<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03270436</url>
  </required_header>
  <id_info>
    <org_study_id>207034</org_study_id>
    <nct_id>NCT03270436</nct_id>
  </id_info>
  <brief_title>Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population</brief_title>
  <official_title>Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct a comparative effectiveness cluster-randomized controlled&#xD;
      trial (cRCT) of two Diabetes Prevention Program (DPP) lifestyle interventions: a faith-based&#xD;
      intervention (Wholeness, Oneness, Righteousness, Deliverance [WORD] DPP); and a Pacific&#xD;
      Islander adapted intervention (Partnership for Improving Lifestyle Interventions [PILI] DPP.&#xD;
      Each intervention lasted 24 weeks and focused on the importance of healthy eating, being&#xD;
      physically active, and maintaining a healthy weight. Eligible participants included&#xD;
      overweight and obese Marshallese adults living in Arkansas and Oklahoma. The unit of&#xD;
      randomization is at the church level. The primary outcome measure is body weight loss (from&#xD;
      baseline weight). As selected by stakeholders, HbA1c, blood pressure, physical activity, and&#xD;
      dietary intake will be evaluated as secondary outcome measures. Data collection will take&#xD;
      place at baseline (pre-intervention), immediate post-intervention (6 months post-initiation&#xD;
      of the intervention), and 6 months post-intervention (12 months post-initiation of the&#xD;
      intervention).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Rationale&#xD;
&#xD;
      Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific&#xD;
      Islanders.&#xD;
&#xD;
      The Marshallese are a Pacific Islander population experiencing significant health&#xD;
      disparities, with some of the highest documented rates of type 2 diabetes of any population&#xD;
      group in the world. Our review of local, national, and international data sources found&#xD;
      estimates of diabetes in the Marshallese population (those living in the US and in the&#xD;
      Republic of the Marshall Islands) ranging from 20% to 50%, compared to 8.3% for the US&#xD;
      population and 4% worldwide. While national prevalence data are limited, 23.7% of Pacific&#xD;
      Islanders surveyed by the Centers for Disease Control and Prevention (CDC) in 2010 reported a&#xD;
      diagnosis of type 2 diabetes, more than all other racial/ethnic groups. Our pilot research,&#xD;
      which includes health screenings with the Marshallese community in northwest Arkansas&#xD;
      (n=398), documented extremely high incidence of diabetes (38.4%) and pre-diabetes (32.6%).&#xD;
      Our pilot data also revealed similar disparities in one of the strongest risk factors for&#xD;
      diabetes-obesity-with 90% of Marshallese participants classified as overweight or obese.&#xD;
      Thirty-two percent of those who had pre-diabetes were also overweight or obese. Further&#xD;
      compounding these significant disparities in diabetes prevalence and related risk factors,&#xD;
      research indicates that Pacific Islanders living in the US are less likely than other&#xD;
      racial/ethnic groups to receive preventative or diagnostic treatment, or diabetes education.&#xD;
&#xD;
      Reducing disparities by reducing weight. Overweight/obesity is considered the strongest&#xD;
      modifiable risk factor for type 2 diabetes, and even a modest reduction in weight (5-10%) can&#xD;
      be clinically meaningful.&#xD;
&#xD;
      Specific aim. Our aim is to compare the effectiveness of achieving weight loss between two&#xD;
      Diabetes Prevention Program (DPP) Lifestyle Interventions - the faith-based Wholeness,&#xD;
      Oneness, Righteousness, Deliverance (WORD) DPP, and the Pacific Islander culturally-adapted&#xD;
      Partnership for Improving Lifestyle Interventions (PILI) DPP - in the Marshallese population&#xD;
      using a cluster randomized controlled trial (cRCT).&#xD;
&#xD;
      Study design. The study design is a comparative effectiveness cRCT conducted in church&#xD;
      settings or other community setting convenient to the participant group. Churches were&#xD;
      selected as the primary setting based on Marshallese stakeholder input.&#xD;
&#xD;
      Randomized participant assignment. Randomization will occur at the church cluster level, with&#xD;
      1:1 assignment of churches to each arm. Churches and community based participant groups will&#xD;
      be blocked (i.e., grouped into similar units) according to geographic region and approximate&#xD;
      number of adult church members. Randomization will be conducted by a biostatistician or&#xD;
      designated investigator, who will have no interactions with potential participants and has no&#xD;
      supervisory role with study staff responsible for recruiting, consent, and intervention&#xD;
      process.&#xD;
&#xD;
      Recruitment and Consent&#xD;
&#xD;
      Church-based recruitment is specified by stakeholders as culturally appropriate and the&#xD;
      community's preferred recruitment method. During recruitment, Marshallese study staff will&#xD;
      give presentations and distribute study information in English and Marshallese. Those who&#xD;
      express interest will complete an eligibility screener, to determine eligibility. All study&#xD;
      information and consent materials will be provided in English and/or Marshallese based upon&#xD;
      the participants' preferences. Eligible participants will be provided a copy of the consent&#xD;
      to review, and participants will have the opportunity to ask questions, consent, and enroll&#xD;
      in the study. The consent process will include providing information to the potential&#xD;
      participants and the opportunity to have bilingual Marshallese staff answer questions&#xD;
      regarding study participation. The consent document will be given to the participant, and the&#xD;
      informed consent process will be documented in the participant's research record.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">May 14, 2020</completion_date>
  <primary_completion_date type="Actual">May 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Comparison of two diabetes prevention program curricula in the Marshallese population.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Mean Body Weight (kg)</measure>
    <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Mean HbA1c (%)</measure>
    <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in mean HbA1c (NGSP %) from baseline to immediate post-intervention and 6 months post-intervention. A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant at each time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Systolic Blood Pressure (mmHg)</measure>
    <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in mean systolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Diastolic Blood Pressure (mmHg)</measure>
    <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in mean diastolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sugar-sweetened Beverage Consumption</measure>
    <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in participants' sugar-sweetened beverage (SSB) consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' SSB consumption over the past 30 days using two questions from 'Module 14: Sugar Sweetened Beverages' of the Center for Disease Control and Prevention's Behavioral Risk Factor Surveillance System (BRFSS). Participants could respond in number of times per day, per week, or per month. Responses for each question were converted to number of times per day (i.e., self-reported times per week divided by 7 or self-reported times per month divided by 30), resulting in two measures: number times soda was consumed per day and number of times sugar-sweetened fruit drinks, sweet tea, and sports drinks were consumed per day. Per BRFSS guidelines, these two measures were added together to create a total daily SSB consumption rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fruit and Vegetable Consumption</measure>
    <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in participants' fruit and vegetable consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' fruit and vegetable consumption over the past three months using three items adapted from: Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997;6(5):355-361. Each of the three items was scored as Often=2; Sometimes=1; Never=0. Items were summed to create a scale score, giving a possible range of scores of 0-6, with higher scores indicating more frequent consumption of fruits and vegetables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity</measure>
    <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in proportion of participants engaging in sufficient levels of physical activity (PA) from baseline to immediate post-intervention and 6 months post-intervention. This measure assessed participants' frequency of engaging in both moderate and vigorous PA over the past month (&gt;4 times a week, 2-4 times a week, about once a week, etc.). This measure was adapted to include relevant cultural examples of PA from the Dietary Approaches to Stop Hypertension 2 Brief Physical Activity Questionnaire (https://biolincc.nhlbi.nih.gov/media/studies/dashsodium/Forms_Manual.pdf?link_time=2018-11-13_18:06:05.776099). Both items used a 4-point response scale: 1) Rarely or Never; 2) Once a week; 3) 2-4 times a week; and 4) More than 4 times a week. Each 4-point scale for moderate PA and vigorous PA was weighted: 0=Rarely or Never; 1=Once a week; 2=2-4 times a week; and 4=More than 4 times a week. The weights were then summed and dichotomized as follows: ≥4 = sufficient PA and &lt;4 = insufficient PA.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Eating Habits Self-efficacy Score</measure>
    <time_frame>Baseline, Immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in eating habits self-efficacy from baseline to immediate post-intervention and 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy related to their ability to make healthy eating decisions in the face of real or perceived barriers (e.g. while at social events, while watching television, etc.). This 7-item measure was adapted from items in the original Weight Efficacy Life-Style (WEL) Questionnaire (Clark MM, Abrams DB, Niaura RS, et al. Self-efficacy in weight management. J Consult Clin Psychol. 1991;59(5):739-744). Each of the 7 items are measured via 3 response options (&quot;Yes/Completely Sure&quot;=2; &quot;Maybe/Not Sure&quot;=1; and &quot;No/Not Sure at All&quot;=0), giving a possible range of scores of 0-14, with higher scores indicating higher self-efficacy for making healthy eating decisions in spite of barriers.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Physical Activity Self-efficacy</measure>
    <time_frame>Baseline, Immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in physical activity self-efficacy from baseline to immediate post-intervention and 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy for exercising in the face of real or perceived barriers (e.g., bad weather, exercising alone, etc.). This 9-item measure was adapted from the Self-Efficacy for Exercise (SEE) Scale (Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000;49(3):154-159. &amp; Resnick B, Luisi D, Vogel A, Junaleepa P. Reliability and validity of the Self-Efficacy for Exercise and Outcome Expectations for Exercise Scales with minority older adults. J Nurs Measurement. 2004; 12(3):235-247.) Each of the 9 items are measured via 3 response options (&quot;Yes/Completely Sure&quot;=2; &quot;Maybe/Not Sure&quot;=1; and &quot;No/Not Sure at All&quot;=0), giving a possible range of scores of 0-18, with higher scores indicating higher self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Perceived Family Support for Exercise and Dietary Habits</measure>
    <time_frame>Baseline, Immediate post-intervention, 6 months post-intervention</time_frame>
    <description>Change in perceived family support for exercise and dietary habits from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure was adapted to examine changes in perceived family support for engaging in healthy exercise and dietary habits. This measure consists of a 6-item scale adapted from: Gruber KJ. Social support for exercise and dietary habits among college students. Adolescence. 2008;43(171):557-575. Each of the 6 items are measured via 3 response options (&quot;Often&quot;=2; &quot;Sometimes&quot;=1; and &quot;Never&quot;=0), giving a possible range of scores of 0-12, with higher scores indicating higher perceived family support for exercising and eating healthier.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">380</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</intervention_name>
    <description>Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
    <arm_group_label>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</intervention_name>
    <description>Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
    <arm_group_label>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self reported Marshallese&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  BMI greater than or equal to 25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS,&#xD;
             etc.)&#xD;
&#xD;
          -  Currently pregnant or breastfeeding an infant who is 6 months old or younger&#xD;
&#xD;
          -  Have any condition that makes it unlikely that the participant will be able to follow&#xD;
             the protocol, such as terminal illness, plans to move out of the area within 6 months,&#xD;
             an inability to finish the intervention, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pearl McElfish, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences Northwest</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <results_first_submitted>October 1, 2020</results_first_submitted>
  <results_first_submitted_qc>November 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 9, 2020</results_first_posted>
  <last_update_submitted>November 13, 2020</last_update_submitted>
  <last_update_submitted_qc>November 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03270436/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
          <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
        </group>
        <group group_id="P2">
          <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
          <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="167"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="212"/>
                <participants group_id="P2" count="166"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Immediate Post-Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="167"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="111"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>6 Months Post-Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="167"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The total number of participants providing data at baseline data collection.Two enrolled participants failed to provide data at baseline.</population>
      <group_list>
        <group group_id="B1">
          <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
          <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
        </group>
        <group group_id="B2">
          <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
          <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="212"/>
            <count group_id="B2" value="166"/>
            <count group_id="B3" value="378"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.9" spread="10.6"/>
                    <measurement group_id="B2" value="41.4" spread="12.8"/>
                    <measurement group_id="B3" value="42.3" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="214"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="212"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="378"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="212"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (kg)</title>
          <description>Participant weight (without shoes) was measured in light clothing using a calibrated digital scale.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85.4" spread="15.6"/>
                    <measurement group_id="B2" value="83.4" spread="14.3"/>
                    <measurement group_id="B3" value="84.4" spread="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Mean Body Weight (kg)</title>
        <description>Change in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.</description>
        <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Body Weight (kg)</title>
          <description>Change in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.</description>
          <units>Kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.44" spread="1.65"/>
                    <measurement group_id="O2" value="84.32" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.47" spread="1.72"/>
                    <measurement group_id="O2" value="84.40" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.18" spread="1.84"/>
                    <measurement group_id="O2" value="83.80" spread="2.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3599</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of change in mean weight from baseline to immediate post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3207</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of change in mean weight from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean HbA1c (%)</title>
        <description>Change in mean HbA1c (NGSP %) from baseline to immediate post-intervention and 6 months post-intervention. A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant at each time point.</description>
        <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean HbA1c (%)</title>
          <description>Change in mean HbA1c (NGSP %) from baseline to immediate post-intervention and 6 months post-intervention. A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant at each time point.</description>
          <units>Percent Glycated Hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.27" spread="0.30"/>
                    <measurement group_id="O2" value="7.66" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.32" spread="0.31"/>
                    <measurement group_id="O2" value="7.55" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.25" spread="0.33"/>
                    <measurement group_id="O2" value="7.61" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5698</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4106</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Systolic Blood Pressure (mmHg)</title>
        <description>Change in mean systolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.</description>
        <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Systolic Blood Pressure (mmHg)</title>
          <description>Change in mean systolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129.42" spread="2.39"/>
                    <measurement group_id="O2" value="128.20" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.83" spread="2.47"/>
                    <measurement group_id="O2" value="119.65" spread="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.75" spread="2.61"/>
                    <measurement group_id="O2" value="118.30" spread="2.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0293</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4686</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Diastolic Blood Pressure (mmHg)</title>
        <description>Change in mean diastolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.</description>
        <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Diastolic Blood Pressure (mmHg)</title>
          <description>Change in mean diastolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.60" spread="1.12"/>
                    <measurement group_id="O2" value="78.33" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.50" spread="1.19"/>
                    <measurement group_id="O2" value="74.08" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.41" spread="1.29"/>
                    <measurement group_id="O2" value="76.24" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0068</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9181</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sugar-sweetened Beverage Consumption</title>
        <description>Change in participants' sugar-sweetened beverage (SSB) consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' SSB consumption over the past 30 days using two questions from 'Module 14: Sugar Sweetened Beverages' of the Center for Disease Control and Prevention's Behavioral Risk Factor Surveillance System (BRFSS). Participants could respond in number of times per day, per week, or per month. Responses for each question were converted to number of times per day (i.e., self-reported times per week divided by 7 or self-reported times per month divided by 30), resulting in two measures: number times soda was consumed per day and number of times sugar-sweetened fruit drinks, sweet tea, and sports drinks were consumed per day. Per BRFSS guidelines, these two measures were added together to create a total daily SSB consumption rate.</description>
        <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sugar-sweetened Beverage Consumption</title>
          <description>Change in participants' sugar-sweetened beverage (SSB) consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' SSB consumption over the past 30 days using two questions from 'Module 14: Sugar Sweetened Beverages' of the Center for Disease Control and Prevention's Behavioral Risk Factor Surveillance System (BRFSS). Participants could respond in number of times per day, per week, or per month. Responses for each question were converted to number of times per day (i.e., self-reported times per week divided by 7 or self-reported times per month divided by 30), resulting in two measures: number times soda was consumed per day and number of times sugar-sweetened fruit drinks, sweet tea, and sports drinks were consumed per day. Per BRFSS guidelines, these two measures were added together to create a total daily SSB consumption rate.</description>
          <units>SSBs consumed per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.65" spread="0.16"/>
                    <measurement group_id="O2" value="2.16" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.24" spread="0.17"/>
                    <measurement group_id="O2" value="1.36" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="0.17"/>
                    <measurement group_id="O2" value="1.40" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5984</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to immediate post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3376</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fruit and Vegetable Consumption</title>
        <description>Change in participants' fruit and vegetable consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' fruit and vegetable consumption over the past three months using three items adapted from: Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997;6(5):355-361. Each of the three items was scored as Often=2; Sometimes=1; Never=0. Items were summed to create a scale score, giving a possible range of scores of 0-6, with higher scores indicating more frequent consumption of fruits and vegetables.</description>
        <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fruit and Vegetable Consumption</title>
          <description>Change in participants' fruit and vegetable consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' fruit and vegetable consumption over the past three months using three items adapted from: Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997;6(5):355-361. Each of the three items was scored as Often=2; Sometimes=1; Never=0. Items were summed to create a scale score, giving a possible range of scores of 0-6, with higher scores indicating more frequent consumption of fruits and vegetables.</description>
          <units>scale score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.59" spread="0.15"/>
                    <measurement group_id="O2" value="3.70" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.94" spread="0.16"/>
                    <measurement group_id="O2" value="3.72" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.10" spread="0.16"/>
                    <measurement group_id="O2" value="3.80" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2960</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in fruit &amp; vegetable consumption scores from baseline to immediate post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1519</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in fruit &amp; vegetable consumption scores from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity</title>
        <description>Change in proportion of participants engaging in sufficient levels of physical activity (PA) from baseline to immediate post-intervention and 6 months post-intervention. This measure assessed participants' frequency of engaging in both moderate and vigorous PA over the past month (&gt;4 times a week, 2-4 times a week, about once a week, etc.). This measure was adapted to include relevant cultural examples of PA from the Dietary Approaches to Stop Hypertension 2 Brief Physical Activity Questionnaire (https://biolincc.nhlbi.nih.gov/media/studies/dashsodium/Forms_Manual.pdf?link_time=2018-11-13_18:06:05.776099). Both items used a 4-point response scale: 1) Rarely or Never; 2) Once a week; 3) 2-4 times a week; and 4) More than 4 times a week. Each 4-point scale for moderate PA and vigorous PA was weighted: 0=Rarely or Never; 1=Once a week; 2=2-4 times a week; and 4=More than 4 times a week. The weights were then summed and dichotomized as follows: ≥4 = sufficient PA and &lt;4 = insufficient PA.</description>
        <time_frame>Baseline, immediate post-intervention, 6 months post-intervention</time_frame>
        <population>Analysis includes only those with data on the relevant outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity</title>
          <description>Change in proportion of participants engaging in sufficient levels of physical activity (PA) from baseline to immediate post-intervention and 6 months post-intervention. This measure assessed participants' frequency of engaging in both moderate and vigorous PA over the past month (&gt;4 times a week, 2-4 times a week, about once a week, etc.). This measure was adapted to include relevant cultural examples of PA from the Dietary Approaches to Stop Hypertension 2 Brief Physical Activity Questionnaire (https://biolincc.nhlbi.nih.gov/media/studies/dashsodium/Forms_Manual.pdf?link_time=2018-11-13_18:06:05.776099). Both items used a 4-point response scale: 1) Rarely or Never; 2) Once a week; 3) 2-4 times a week; and 4) More than 4 times a week. Each 4-point scale for moderate PA and vigorous PA was weighted: 0=Rarely or Never; 1=Once a week; 2=2-4 times a week; and 4=More than 4 times a week. The weights were then summed and dichotomized as follows: ≥4 = sufficient PA and &lt;4 = insufficient PA.</description>
          <population>Analysis includes only those with data on the relevant outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted repeated measures generalized estimating equations (GEE) model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2824</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of change from baseline to immediate post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>Mantel Haenszel</method>
            <method_desc>The model includes only the study arm and time interaction.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted repeated measures generalized estimating equations (GEE) model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7547</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of change from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>Mantel Haenszel</method>
            <method_desc>The model includes only the study arm and time interaction.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Eating Habits Self-efficacy Score</title>
        <description>Change in eating habits self-efficacy from baseline to immediate post-intervention and 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy related to their ability to make healthy eating decisions in the face of real or perceived barriers (e.g. while at social events, while watching television, etc.). This 7-item measure was adapted from items in the original Weight Efficacy Life-Style (WEL) Questionnaire (Clark MM, Abrams DB, Niaura RS, et al. Self-efficacy in weight management. J Consult Clin Psychol. 1991;59(5):739-744). Each of the 7 items are measured via 3 response options (&quot;Yes/Completely Sure&quot;=2; &quot;Maybe/Not Sure&quot;=1; and &quot;No/Not Sure at All&quot;=0), giving a possible range of scores of 0-14, with higher scores indicating higher self-efficacy for making healthy eating decisions in spite of barriers.</description>
        <time_frame>Baseline, Immediate post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Eating Habits Self-efficacy Score</title>
          <description>Change in eating habits self-efficacy from baseline to immediate post-intervention and 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy related to their ability to make healthy eating decisions in the face of real or perceived barriers (e.g. while at social events, while watching television, etc.). This 7-item measure was adapted from items in the original Weight Efficacy Life-Style (WEL) Questionnaire (Clark MM, Abrams DB, Niaura RS, et al. Self-efficacy in weight management. J Consult Clin Psychol. 1991;59(5):739-744). Each of the 7 items are measured via 3 response options (&quot;Yes/Completely Sure&quot;=2; &quot;Maybe/Not Sure&quot;=1; and &quot;No/Not Sure at All&quot;=0), giving a possible range of scores of 0-14, with higher scores indicating higher self-efficacy for making healthy eating decisions in spite of barriers.</description>
          <units>scale score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.97" spread="0.26"/>
                    <measurement group_id="O2" value="11.46" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.77" spread="0.28"/>
                    <measurement group_id="O2" value="11.92" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.87" spread="0.28"/>
                    <measurement group_id="O2" value="11.62" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6928</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4947</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Physical Activity Self-efficacy</title>
        <description>Change in physical activity self-efficacy from baseline to immediate post-intervention and 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy for exercising in the face of real or perceived barriers (e.g., bad weather, exercising alone, etc.). This 9-item measure was adapted from the Self-Efficacy for Exercise (SEE) Scale (Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000;49(3):154-159. &amp; Resnick B, Luisi D, Vogel A, Junaleepa P. Reliability and validity of the Self-Efficacy for Exercise and Outcome Expectations for Exercise Scales with minority older adults. J Nurs Measurement. 2004; 12(3):235-247.) Each of the 9 items are measured via 3 response options (&quot;Yes/Completely Sure&quot;=2; &quot;Maybe/Not Sure&quot;=1; and &quot;No/Not Sure at All&quot;=0), giving a possible range of scores of 0-18, with higher scores indicating higher self-efficacy.</description>
        <time_frame>Baseline, Immediate post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Physical Activity Self-efficacy</title>
          <description>Change in physical activity self-efficacy from baseline to immediate post-intervention and 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy for exercising in the face of real or perceived barriers (e.g., bad weather, exercising alone, etc.). This 9-item measure was adapted from the Self-Efficacy for Exercise (SEE) Scale (Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000;49(3):154-159. &amp; Resnick B, Luisi D, Vogel A, Junaleepa P. Reliability and validity of the Self-Efficacy for Exercise and Outcome Expectations for Exercise Scales with minority older adults. J Nurs Measurement. 2004; 12(3):235-247.) Each of the 9 items are measured via 3 response options (&quot;Yes/Completely Sure&quot;=2; &quot;Maybe/Not Sure&quot;=1; and &quot;No/Not Sure at All&quot;=0), giving a possible range of scores of 0-18, with higher scores indicating higher self-efficacy.</description>
          <units>scale score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.64" spread="0.41"/>
                    <measurement group_id="O2" value="14.24" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.87" spread="0.44"/>
                    <measurement group_id="O2" value="14.72" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.34" spread="0.44"/>
                    <measurement group_id="O2" value="13.57" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1539</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1878</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Perceived Family Support for Exercise and Dietary Habits</title>
        <description>Change in perceived family support for exercise and dietary habits from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure was adapted to examine changes in perceived family support for engaging in healthy exercise and dietary habits. This measure consists of a 6-item scale adapted from: Gruber KJ. Social support for exercise and dietary habits among college students. Adolescence. 2008;43(171):557-575. Each of the 6 items are measured via 3 response options (&quot;Often&quot;=2; &quot;Sometimes&quot;=1; and &quot;Never&quot;=0), giving a possible range of scores of 0-12, with higher scores indicating higher perceived family support for exercising and eating healthier.</description>
        <time_frame>Baseline, Immediate post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
            <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
          </group>
          <group group_id="O2">
            <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
            <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Perceived Family Support for Exercise and Dietary Habits</title>
          <description>Change in perceived family support for exercise and dietary habits from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure was adapted to examine changes in perceived family support for engaging in healthy exercise and dietary habits. This measure consists of a 6-item scale adapted from: Gruber KJ. Social support for exercise and dietary habits among college students. Adolescence. 2008;43(171):557-575. Each of the 6 items are measured via 3 response options (&quot;Often&quot;=2; &quot;Sometimes&quot;=1; and &quot;Never&quot;=0), giving a possible range of scores of 0-12, with higher scores indicating higher perceived family support for exercising and eating healthier.</description>
          <units>scale score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.99" spread="0.25"/>
                    <measurement group_id="O2" value="5.50" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediate post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.66" spread="0.27"/>
                    <measurement group_id="O2" value="6.38" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.48" spread="0.27"/>
                    <measurement group_id="O2" value="6.46" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4322</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to immediate post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Repeated measures regression model used all available participant data (no listwise deletion).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9529</p_value>
            <p_value_desc>The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to 6 months post-intervention. Analyses do not include imputed values.</p_value_desc>
            <method>linear mixed effects regression</method>
            <method_desc>Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From enrollment to 1 year post-enrollment</time_frame>
      <desc>Study staff assessed presence of adverse events via regular contact with participants from both study arms throughout the duration of the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program</title>
          <description>The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.&#xD;
WORD DPP: Faith based diabetes curriculum that teaches participants to connect faith and health.</description>
        </group>
        <group group_id="E2">
          <title>Partnership for Improving Lifestyle Intervention Diabetes Prevention Program</title>
          <description>The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.&#xD;
PILI DPP: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="167"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="167"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="167"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Pearl A. McElfish</name_or_title>
      <organization>University of Arkansas for Medical Sciences</organization>
      <phone>479-713-8680</phone>
      <email>pamcelfish@uams.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03270436
org study id: 207034
nct id: NCT03270436
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators will conduct a comparative effectiveness cluster-randomized controlled
      trial (cRCT) of two Diabetes Prevention Program (DPP) lifestyle interventions: a faith-based
      intervention (Wholeness, Oneness, Righteousness, Deliverance [WORD] DPP); and a Pacific
      Islander adapted intervention (Partnership for Improving Lifestyle Interventions [PILI] DPP.
      Each intervention lasted 24 weeks and focused on the importance of healthy eating, being
      physically active, and maintaining a healthy weight. Eligible participants included
      overweight and obese Marshallese adults living in Arkansas and Oklahoma. The unit of
      randomization is at the church level. The primary outcome measure is body weight loss (from
      baseline weight). As selected by stakeholders, HbA1c, blood pressure, physical activity, and
      dietary intake will be evaluated as secondary outcome measures. Data collection will take
      place at baseline (pre-intervention), immediate post-intervention (6 months post-initiation
      of the intervention), and 6 months post-intervention (12 months post-initiation of the
      intervention).
Background and Rationale

      Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific
      Islanders.

      The Marshallese are a Pacific Islander population experiencing significant health
      disparities, with some of the highest documented rates of type 2 diabetes of any population
      group in the world. Our review of local, national, and international data sources found
      estimates of diabetes in the Marshallese population (those living in the US and in the
      Republic of the Marshall Islands) ranging from 20% to 50%, compared to 8.3% for the US
      population and 4% worldwide. While national prevalence data are limited, 23.7% of Pacific
      Islanders surveyed by the Centers for Disease Control and Prevention (CDC) in 2010 reported a
      diagnosis of type 2 diabetes, more than all other racial/ethnic groups. Our pilot research,
      which includes health screenings with the Marshallese community in northwest Arkansas
      (n=398), documented extremely high incidence of diabetes (38.4%) and pre-diabetes (32.6%).
      Our pilot data also revealed similar disparities in one of the strongest risk factors for
      diabetes-obesity-with 90% of Marshallese participants classified as overweight or obese.
      Thirty-two percent of those who had pre-diabetes were also overweight or obese. Further
      compounding these significant disparities in diabetes prevalence and related risk factors,
      research indicates that Pacific Islanders living in the US are less likely than other
      racial/ethnic groups to receive preventative or diagnostic treatment, or diabetes education.

      Reducing disparities by reducing weight. Overweight/obesity is considered the strongest
      modifiable risk factor for type 2 diabetes, and even a modest reduction in weight (5-10%) can
      be clinically meaningful.

      Specific aim. Our aim is to compare the effectiveness of achieving weight loss between two
      Diabetes Prevention Program (DPP) Lifestyle Interventions - the faith-based Wholeness,
      Oneness, Righteousness, Deliverance (WORD) DPP, and the Pacific Islander culturally-adapted
      Partnership for Improving Lifestyle Interventions (PILI) DPP - in the Marshallese population
      using a cluster randomized controlled trial (cRCT).

      Study design. The study design is a comparative effectiveness cRCT conducted in church
      settings or other community setting convenient to the participant group. Churches were
      selected as the primary setting based on Marshallese stakeholder input.

      Randomized participant assignment. Randomization will occur at the church cluster level, with
      1:1 assignment of churches to each arm. Churches and community based participant groups will
      be blocked (i.e., grouped into similar units) according to geographic region and approximate
      number of adult church members. Randomization will be conducted by a biostatistician or
      designated investigator, who will have no interactions with potential participants and has no
      supervisory role with study staff responsible for recruiting, consent, and intervention
      process.

      Recruitment and Consent

      Church-based recruitment is specified by stakeholders as culturally appropriate and the
      community's preferred recruitment method. During recruitment, Marshallese study staff will
      give presentations and distribute study information in English and Marshallese. Those who
      express interest will complete an eligibility screener, to determine eligibility. All study
      information and consent materials will be provided in English and/or Marshallese based upon
      the participants' preferences. Eligible participants will be provided a copy of the consent
      to review, and participants will have the opportunity to ask questions, consent, and enroll
      in the study. The consent process will include providing information to the potential
      participants and the opportunity to have bilingual Marshallese staff answer questions
      regarding study participation. The consent document will be given to the participant, and the
      informed consent process will be documented in the participant's research record.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparison of two diabetes prevention program curricula in the Marshallese population.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Mean Body Weight (kg)
time frame: Baseline, immediate post-intervention, 6 months post-intervention
description: Change in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.
measure: Change in Mean HbA1c (%)
time frame: Baseline, immediate post-intervention, 6 months post-intervention
description: Change in mean HbA1c (NGSP %) from baseline to immediate post-intervention and 6 months post-intervention. A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant at each time point.
measure: Change in Mean Systolic Blood Pressure (mmHg)
time frame: Baseline, immediate post-intervention, 6 months post-intervention
description: Change in mean systolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.
measure: Change in Mean Diastolic Blood Pressure (mmHg)
time frame: Baseline, immediate post-intervention, 6 months post-intervention
description: Change in mean diastolic blood pressure (mmHg) from baseline to immediate post-intervention and 6 months post-intervention. Blood pressure was measured at each time point with a sphygmomanometer and stethoscope or digital blood pressure device, with participants seated and arm elevated.
measure: Change in Sugar-sweetened Beverage Consumption
time frame: Baseline, immediate post-intervention, 6 months post-intervention
description: Change in participants' sugar-sweetened beverage (SSB) consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' SSB consumption over the past 30 days using two questions from 'Module 14: Sugar Sweetened Beverages' of the Center for Disease Control and Prevention's Behavioral Risk Factor Surveillance System (BRFSS). Participants could respond in number of times per day, per week, or per month. Responses for each question were converted to number of times per day (i.e., self-reported times per week divided by 7 or self-reported times per month divided by 30), resulting in two measures: number times soda was consumed per day and number of times sugar-sweetened fruit drinks, sweet tea, and sports drinks were consumed per day. Per BRFSS guidelines, these two measures were added together to create a total daily SSB consumption rate.
measure: Change in Fruit and Vegetable Consumption
time frame: Baseline, immediate post-intervention, 6 months post-intervention
description: Change in participants' fruit and vegetable consumption from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure assessed participants' fruit and vegetable consumption over the past three months using three items adapted from: Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997;6(5):355-361. Each of the three items was scored as Often=2; Sometimes=1; Never=0. Items were summed to create a scale score, giving a possible range of scores of 0-6, with higher scores indicating more frequent consumption of fruits and vegetables.
measure: Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity
time frame: Baseline, immediate post-intervention, 6 months post-intervention
description: Change in proportion of participants engaging in sufficient levels of physical activity (PA) from baseline to immediate post-intervention and 6 months post-intervention. This measure assessed participants' frequency of engaging in both moderate and vigorous PA over the past month (>4 times a week, 2-4 times a week, about once a week, etc.). This measure was adapted to include relevant cultural examples of PA from the Dietary Approaches to Stop Hypertension 2 Brief Physical Activity Questionnaire (https://biolincc.nhlbi.nih.gov/media/studies/dashsodium/Forms_Manual.pdf?link_time=2018-11-13_18:06:05.776099). Both items used a 4-point response scale: 1) Rarely or Never; 2) Once a week; 3) 2-4 times a week; and 4) More than 4 times a week. Each 4-point scale for moderate PA and vigorous PA was weighted: 0=Rarely or Never; 1=Once a week; 2=2-4 times a week; and 4=More than 4 times a week. The weights were then summed and dichotomized as follows: ≥4 = sufficient PA and <4 = insufficient PA.
measure: Change in Eating Habits Self-efficacy Score
time frame: Baseline, Immediate post-intervention, 6 months post-intervention
description: Change in eating habits self-efficacy from baseline to immediate post-intervention and 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy related to their ability to make healthy eating decisions in the face of real or perceived barriers (e.g. while at social events, while watching television, etc.). This 7-item measure was adapted from items in the original Weight Efficacy Life-Style (WEL) Questionnaire (Clark MM, Abrams DB, Niaura RS, et al. Self-efficacy in weight management. J Consult Clin Psychol. 1991;59(5):739-744). Each of the 7 items are measured via 3 response options ("Yes/Completely Sure"=2; "Maybe/Not Sure"=1; and "No/Not Sure at All"=0), giving a possible range of scores of 0-14, with higher scores indicating higher self-efficacy for making healthy eating decisions in spite of barriers.
measure: Change in Physical Activity Self-efficacy
time frame: Baseline, Immediate post-intervention, 6 months post-intervention
description: Change in physical activity self-efficacy from baseline to immediate post-intervention and 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy for exercising in the face of real or perceived barriers (e.g., bad weather, exercising alone, etc.). This 9-item measure was adapted from the Self-Efficacy for Exercise (SEE) Scale (Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000;49(3):154-159. & Resnick B, Luisi D, Vogel A, Junaleepa P. Reliability and validity of the Self-Efficacy for Exercise and Outcome Expectations for Exercise Scales with minority older adults. J Nurs Measurement. 2004; 12(3):235-247.) Each of the 9 items are measured via 3 response options ("Yes/Completely Sure"=2; "Maybe/Not Sure"=1; and "No/Not Sure at All"=0), giving a possible range of scores of 0-18, with higher scores indicating higher self-efficacy.
measure: Change in Perceived Family Support for Exercise and Dietary Habits
time frame: Baseline, Immediate post-intervention, 6 months post-intervention
description: Change in perceived family support for exercise and dietary habits from baseline to immediate post-intervention and 6 months post-intervention. This self-report measure was adapted to examine changes in perceived family support for engaging in healthy exercise and dietary habits. This measure consists of a 6-item scale adapted from: Gruber KJ. Social support for exercise and dietary habits among college students. Adolescence. 2008;43(171):557-575. Each of the 6 items are measured via 3 response options ("Often"=2; "Sometimes"=1; and "Never"=0), giving a possible range of scores of 0-12, with higher scores indicating higher perceived family support for exercising and eating healthier.
arm group label: Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
arm group type: Experimental
description: The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.
arm group label: Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
arm group type: Experimental
description: The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.
intervention type: Behavioral
intervention name: Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
description: Faith based diabetes curriculum that teaches participants to connect faith and health.
arm group label: Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program
intervention type: Behavioral
intervention name: Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
description: Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
arm group label: Partnership for Improving Lifestyle Intervention Diabetes Prevention Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pearl McElfish, PhD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
participant flow: 
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certain agreements: 
point of contact: 