<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/NCT03781102</url>
  </required_header>
  <id_info>
    <org_study_id>1R34DK118486-01</org_study_id>
    <nct_id>NCT03781102</nct_id>
  </id_info>
  <brief_title>Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers</brief_title>
  <official_title>Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</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 two main questions that this research study will answer:&#xD;
&#xD;
        1. will a 16-week community-based diabetes prevention program for delivery to at-risk&#xD;
           mothers and children in a Federally Qualified Health Center (FQHC) setting show (a) pre-&#xD;
           and post-intervention improvements to Type 2 Diabetes risk factors in 60 mother-child&#xD;
           dyads; (b) intervention vs. control improvements to T2D risk factors in 30 mother-child&#xD;
           dyads; and (c) maintenance effects to changes to Type 2 Diabetes risk factors in 30&#xD;
           mother-child dyads; and&#xD;
&#xD;
        2. based on the acceptability, adoption, relevance to FQHC and participants, feasibility,&#xD;
           fidelity, program costs, and factors influencing sustainability of this program, can it&#xD;
           be disseminated nationwide to other FQHC's?&#xD;
&#xD;
      The investigators hypothesize that participants (a) will show improvements following the&#xD;
      intervention to T2D risk factors, (b) in the intervention will show significant improvements&#xD;
      to T2D risk factors in versus the controls, and (c) will maintain the benefits beyond the&#xD;
      16-week intervention. The investigators also predict that this program will meet criteria to&#xD;
      be disseminated nationwide to other FQHC's.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal is to implement and evaluate the effects of a 16-week behavioral lifestyle&#xD;
      intervention on Type 2 Diabetes (T2D) risk factors delivered by trained staff at a Federally&#xD;
      Qualified Health Center (FQHC) to 60 mothers with prediabetes or a history of gestational&#xD;
      diabetes (GDM) and 60 overweight/obese children. The specific aims are to (1) adapt an&#xD;
      efficacious community-based diabetes prevention program for delivery to FQHC patients, (2)&#xD;
      evaluate indicators of program implementation and potential for dissemination (Proctor 2011),&#xD;
      and (3) assess the preliminary impact of the program on participants' T2D risk factors.&#xD;
&#xD;
      The study aims to adapt an efficacious community-based diabetes prevention program developed&#xD;
      for delivery to at-risk mothers and children at a FQHC. Successful T2D prevention in children&#xD;
      necessitates family adoption of lifestyle behaviors associated with prevention of excess&#xD;
      weight gain, while supporting normal growth and development. In accord with the 2012&#xD;
      Institute of Medicine Report (IOM 2012) and guidelines set forth by an Expert Committee&#xD;
      (Barlow 2007), three healthy lifestyle goals form the basis for youth-focused aspects of the&#xD;
      intervention: i) make physical activity an integral and routine part of life; ii) eat a&#xD;
      healthy diet (both quality and quantity), and, iii) create food and physical activity&#xD;
      environments to insure healthy options and behaviors are the routine, easy choice. These&#xD;
      goals align with two evidence-based T2D prevention goals mothers will be encouraged to adopt:&#xD;
      i) lose 7% of body weight through healthy eating, and ii) participate in at least 150 minutes&#xD;
      of moderate-to-vigorous physical activity each week. Achievement of these goals has been&#xD;
      associated with significant T2D risk reduction in participants of programs based on the&#xD;
      Centers for Disease Control and Prevention (CDC) National Diabetes Prevention Program (CDC&#xD;
      2017, Albright 2013). The intervention duration, content, and activities, designed to support&#xD;
      families in meeting these recommendations, were drawn from the intervention literature&#xD;
      (Wilfley 2010, Epstein 2007, Ackermann 2008, Hingle 2015). Intervention &quot;dose&quot; (duration ×&#xD;
      time) was modeled after the successful adult-focused DPP/YDPP (characterized by 16 core&#xD;
      sessions) and the recently released 2017 U.S. Preventive Services Task Force (USPSTF)&#xD;
      evidence-based recommendations for weight loss, behavior change, and cardio-metabolic risk&#xD;
      reduction in youth (O'Connor 2017). The topics are focused on practical, culturally-relevant&#xD;
      strategies for modifying the behaviors associated with the pathogenesis of T2D in youth&#xD;
      (Spruijt-Metz 2014) (e.g., availability and accessibility of nutrient- and calorie-dense&#xD;
      foods and food preparation strategies in the home, reducing intake of sugar-sweetened&#xD;
      beverages, increasing time spent in physical activity/decreasing time spent in sedentary&#xD;
      activities, stress management, and obtaining quality sleep), while engaging participants in&#xD;
      fun, active, and interactive food demonstrations, energy balance, and physical activities&#xD;
      appropriate for the entire family. All sessions are group-based (attended by up to 10&#xD;
      families total) and led by a minimum of two trained bilingual FQHC health and wellness staff.&#xD;
      The sessions will be approximately 1.5-2 hours in length and conducted over 16 consecutive&#xD;
      weeks at one of two FQHC locations. The sessions foster skill building and provide repeated&#xD;
      opportunities to practice healthy lifestyle behaviors. Each session will follow a similar&#xD;
      format consisting of: (1) a featured physical activity encouraging families to get moving&#xD;
      upon arrival; (2) small group discussions focused on goal-setting and building intra- and&#xD;
      inter-family camaraderie; (3) hands-on food preparation and tasting opportunities centered&#xD;
      around vegetables, whole grains, and legumes; (4) low- to no-cost fun family physical&#xD;
      activities (on alternating weeks, mothers will participate in a moderated discussion on&#xD;
      proactive parenting); (5) energy balance activities (e.g. label reading) to increase&#xD;
      foundational knowledge and skills related to healthy food selection, physical activity&#xD;
      benefits, and creating a supportive home environment; and, (6) opportunities to set new&#xD;
      weekly goals (or revise previous goals).&#xD;
&#xD;
      The second aim evaluates program implementation outcomes including acceptability, adoption,&#xD;
      relevance to FQHC and participants, feasibility, fidelity, program costs, and factors&#xD;
      influencing sustainability. Consistent with the tenets of implementation science (Glasgow&#xD;
      2012), these variables are assessed at recommended time points (Proctor 2011) to insure all&#xD;
      aspects of the intervention work as intended, including participant acceptability&#xD;
      (participant satisfaction) and relevance to FQHC personnel and study participants (rated&#xD;
      using brief surveys of the relevance of the intervention to daily life, promoters and&#xD;
      barriers to program attendance and engagement, the degree to which families report using the&#xD;
      intervention to guide behavioral choices, and surveys of lifestyle coaches trained to deliver&#xD;
      the intervention). The investigators also assess adoption by the FQHC and integration with&#xD;
      the existing clinical setting (ascertained through semi-structured interviews with FQHC&#xD;
      wellness staff and administrators exploring 'fit' among existing program offerings,&#xD;
      availability of personnel and resources needed to implement, and potential for reimbursement)&#xD;
      and feasibility (of delivery by providers and FQHC determined by recruitment, enrollment, and&#xD;
      retention rates, adherence data including session attendance and observed participant&#xD;
      engagement with intervention activities; a brief, three-question interview will be conducted&#xD;
      with every eligible respondent who elects not to participate). Fidelity is assessed through&#xD;
      observation of research staff following an established rubric, and program costs are&#xD;
      evaluated using a bottom-up micro-costing approach (for participants, surveys assessing cost,&#xD;
      burden, and benefit such as time and resources spent in travel, services, equipment, and food&#xD;
      to meet program recommendations; FQHC direct medical and non-medical costs including&#xD;
      personnel gross hourly salaries, intervention material costs, and overhead costs related to&#xD;
      use of facilities for prevention services are tracked and analyzed in partnership with FQHC&#xD;
      data team members). The investigators also explore the potential for replication and&#xD;
      dissemination using semi-structured interviews with the FQHC wellness staff assigned to&#xD;
      coordinate and deliver the program, and administrators and advisory board members who&#xD;
      understand how to align the intervention with the FQHC's fiscal and strategic plans, and who&#xD;
      have relationships with other FQHCs in Arizona and nationally. Program sustainability is also&#xD;
      of great interest to the FQHC, thus our a priori focus on factors influencing sustainability&#xD;
      (e.g., reach, integration with other health/wellness programs, institutionalization) beyond&#xD;
      the research funding period are a major consideration throughout the proposed study. At the&#xD;
      conclusion of the proposed work, this evaluation is designed to produce an intervention&#xD;
      curriculum and approach suitable for replication and scaling across a larger number of&#xD;
      (cluster-randomized) FQHC sites.&#xD;
&#xD;
      The third aim is to assess the preliminary efficacy of the program on T2D risk factors&#xD;
      including weight status, metabolic syndrome phenotype, lifestyle behaviors, and&#xD;
      socio-environmental determinants of health outcomes in 60 mothers and 60 children&#xD;
      participating in the 16-week intervention. Intervention participants are measured at Week 0&#xD;
      (baseline), Week 16 (post-intervention), and Week 32 (maintenance) and wait-listed control&#xD;
      participants at Week 0 (baseline), Week 16 (follow-up and pre-intervention), and Week 32&#xD;
      (post-intervention). Measurements are conducted by trained research staff following&#xD;
      standardized measurement procedures, and take place at the FQHC site to which the child and&#xD;
      parent is assigned. Care is taken to avoid simultaneous scheduling of intervention and&#xD;
      wait-listed control families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    COVID19&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Anticipated">September 14, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>Participants (60 children and their biological mothers (n=120)) will be assigned to a clinic location nearest to their home address, which will determine the order in which they will complete the 16-week intervention. Two clinics were selected to participate in this pilot study. Randomization to the intervention and wait-list control conditions will be performed *by site* (flip of a coin). Randomization by site is proposed as it has the least potential for contamination during the initial delivery period. Group A participants (n=30) will begin the 16-week face-to-face group program immediately, whereas the Group B participants (n=30) will receive normal standard of care. After 16 weeks, the Group A participants will transition to follow-up while the Group B participants begin the intervention. This design is responsive to standards of care for T2D prevention by primary care providers and will provide the opportunity to investigate all the outcome questions.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>Body weight (kg) is measured using a calibrated, Cardinal Detecto ProDoc Series PD300MHR Digital Physician scale and a Cardinal Detecto 758C Weight Indicator</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Height</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>Body height (cm) measured using a calibrated, Cardinal Detecto ProDoc Series PD300MHR Digital Physician scale with a mechanical height rod and a Cardinal Detecto 758C Weight Indicator with a Seca 213 Portable Stadiometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>BMI (kg/m2) is categorized using international classifications of BMI (overweight, 25-29.9kg/m2; obese, &gt;30kg/m2) (WHO 2006).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Mass Index (BMI) Percentile</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>BMI percentile in children is determined using age- and sex-specific growth charts developed by the CDC in 2000 (Kuczmarski 2000).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Circumference</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>Child and adult waist circumferences are measured at the umbilicus. All measures are completed in duplicate, and the average of the two measures is used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Blood Pressure</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>Blood pressure assessed with an aneroid sphygmomanometer and with a Mindray Accutorr V vital signs monitor with an appropriate-sized cuff after participants are seated and relaxed for at least 5 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1C</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>HbA1C as assessed using a finger stick sample will be collected using a Siemens Diagnostics DCA HbA1C analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Cholesterol / HDL-cholesterol</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>Total Cholesterol and HDL-cholesterol as assessed using a finger stick sample will be measured using a Cholestech LDX® lipid analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dietary Intake (daily eating patterns)</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>Dietary Intake - Child - assessed with interviewer-administered 24-hr dietary recalls. Parent- assessed using Arizona Food Frequency Questionnaire (AFFQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Moderate to vigorous physical activity (MVPA) and sedentary behavior</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>MVPA and sedentary behavior - Child - assessed using the Youth Activity Profile (YAP). Parent - assessed using the Arizona Activity Frequency Questionnaire (AAFQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep behavior (daily sleeping patterns)</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>Sleep Behavior - Child - assessed using the Children's Sleep Habits Questionnaire, Abbreviated. Adult - N/A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in home food and physical activity environment</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>Home food and physical activity environment - assessed using the Family Nutrition and Physical Activity Tool (FNPA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in demographic and social and environmental risk factors for T2D</measure>
    <time_frame>Baseline, Week 16, Week 32</time_frame>
    <description>Demographic and social and environmental risk factors for T2D will be assessed using the Sangre Por Salud Biobank Health Questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>PreDiabetes</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 1, or intervention participants (n=60), will participate in a 16-week face-to-face diabetes prevention group program '16-Week Diabetes Prevention Program for Mothers and Children' and then will transition to a 16-week follow-up period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-listed Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Arm 2, or wait-listed controls (n=60), will receive the typical standard of care during the first 16-weeks, followed by the 16-week face-to-face group diabetes prevention program '16-Week Diabetes Prevention Program for Mothers and Children'.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>16-Week Diabetes Prevention Program for Mothers and Children</intervention_name>
    <description>The 16-week intervention is focused on ways to modify behaviors associated with the pathogenesis of Type 2 Diabetes in youth, while engaging participants in fun, active, and interactive food demonstrations, energy balance, and physical activities appropriate for all the family. Weekly sessions will consist of: (1) physical activity upon arrival; (2) small group discussions; (3) hands-on food preparation and tasting opportunities; (4) low- to no-cost fun family physical activities; (5) energy balance activities (e.g. label reading) to increase foundational knowledge; and, (6) opportunities to set new weekly goals.</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Wait-listed Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Child:&#xD;
&#xD;
        8-12-years-old (if the mother has more than one child in the age range, the oldest child&#xD;
        will be invited to participate; other children will be invited to join if the mother wishes&#xD;
        it, but will not be measured),&#xD;
&#xD;
        overweight/obese (≥85th percentile of BMI for age and sex, and ≥2 of the following T2D risk&#xD;
        factors: family history of T2D in first or second degree relative; or, identify as a&#xD;
        racial/ethnic minority; or, exhibit signs of insulin resistance or conditions associated&#xD;
        with insulin resistance, or mother with T2D or GDM during gestation.&#xD;
&#xD;
        Able to read and speak English, and provide written assent.&#xD;
&#xD;
        Mother:&#xD;
&#xD;
        18-54 years-old,&#xD;
&#xD;
        BMI ≥ 25 kg/m2 and a risk score ≥5 on the seven-item American Diabetes Association's&#xD;
        Diabetes Risk Assessment (84). In addition, women must have prediabetes, determined by an&#xD;
        HbA1c value &gt;5.7% and &lt;6.5%, or, a self-reported or chart documented history of gestational&#xD;
        diabetes mellitus with an HbA1c &lt;6.5% and/or casual capillary blood glucose &lt;199 mg/dL.&#xD;
&#xD;
        Must be willing to participate with their child in all intervention activities and&#xD;
        sessions,&#xD;
&#xD;
        Able to read and speak English or Spanish, and provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Mother:&#xD;
&#xD;
        No evidence of prediabetes&#xD;
&#xD;
        Currently pregnant or planning to become pregnant during the study&#xD;
&#xD;
        Have any condition or use any medication that could alter glucose metabolism or weight&#xD;
&#xD;
        Have suffered a heart attack, stroke or transient ischemic attack (TIA) in the past 6&#xD;
        months&#xD;
&#xD;
        Have uncontrolled hypertension (systolic &gt;180 mmHg or diastolic &gt;105 mmHg)&#xD;
&#xD;
        Received treatment for cancer (excluding surgery alone) within the last 2 years (excluding&#xD;
        skin cancer)&#xD;
&#xD;
        Report chest pain, shortness of breath with minimal activity or at rest or unexplained&#xD;
        dizziness or fainting with physical activity,&#xD;
&#xD;
        Have chronic lung disease, chronic obstructive pulmonary disease, or asthma requiring home&#xD;
        oxygen therapy,&#xD;
&#xD;
        Current use of anti-diabetes medications for the treatment of diagnosed diabetes, are&#xD;
        unable to communicate with research staff (including intervention staff),&#xD;
&#xD;
        Do not have a child within the designated age range (8-12-years-old),&#xD;
&#xD;
        Unable to speak or read English or Spanish.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melanie D Hingle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David G Marrero, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>El Rio Community Health Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.</citation>
    <PMID>20957426</PMID>
  </reference>
  <reference>
    <citation>Committee on Accelerating Progress in Obesity Prevention; Food and Nutrition Board; Institute of Medicine; Glickman D, Parker L, Sim LJ, Del Valle Cook H, Miller EA, editors. Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation. Washington (DC): National Academies Press (US); 2012 May 8. Available from http://www.ncbi.nlm.nih.gov/books/NBK201141/</citation>
    <PMID>24830053</PMID>
  </reference>
  <reference>
    <citation>Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.</citation>
    <PMID>18055651</PMID>
  </reference>
  <reference>
    <citation>Centers for Disease Control and Prevention. National Diabetes Prevention Program 2017. Available at: https://www.cdc.gov/diabetes/prevention/index.html [Accessed on October 18, 2017]</citation>
  </reference>
  <reference>
    <citation>Albright AL, Gregg EW. Preventing type 2 diabetes in communities across the U.S.: the National Diabetes Prevention Program. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S346-51. doi: 10.1016/j.amepre.2012.12.009.</citation>
    <PMID>23498297</PMID>
  </reference>
  <reference>
    <citation>Wilfley DE, Vannucci A, White EK. Early intervention of eating- and weight-related problems. J Clin Psychol Med Settings. 2010 Dec;17(4):285-300. doi: 10.1007/s10880-010-9209-0.</citation>
    <PMID>20960039</PMID>
  </reference>
  <reference>
    <citation>Epstein LH, Paluch RA, Roemmich JN, Beecher MD. Family-based obesity treatment, then and now: twenty-five years of pediatric obesity treatment. Health Psychol. 2007 Jul;26(4):381-91. doi: 10.1037/0278-6133.26.4.381.</citation>
    <PMID>17605557</PMID>
  </reference>
  <reference>
    <citation>Ackermann RT, Finch EA, Brizendine E, Zhou H, Marrero DG. Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. Am J Prev Med. 2008 Oct;35(4):357-63. doi: 10.1016/j.amepre.2008.06.035.</citation>
    <PMID>18779029</PMID>
  </reference>
  <reference>
    <citation>Hingle MD, Turner T, Kutob R, Merchant N, Roe DJ, Stump C, Going SB. The EPIC Kids Study: a randomized family-focused YMCA-based intervention to prevent type 2 diabetes in at-risk youth. BMC Public Health. 2015 Dec 18;15:1253. doi: 10.1186/s12889-015-2595-3.</citation>
    <PMID>26679186</PMID>
  </reference>
  <reference>
    <citation>O'Connor EA, Evans CV, Burda BU, Walsh ES, Eder M, Lozano P. Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017 Jun 20;317(23):2427-2444. doi: 10.1001/jama.2017.0332.</citation>
    <PMID>28632873</PMID>
  </reference>
  <reference>
    <citation>Spruijt-Metz D, O'Reilly GA, Cook L, Page KA, Quinn C. Behavioral contributions to the pathogenesis of type 2 diabetes. Curr Diab Rep. 2014 Apr;14(4):475. doi: 10.1007/s11892-014-0475-3.</citation>
    <PMID>24604714</PMID>
  </reference>
  <reference>
    <citation>Glasgow RE, Vinson C, Chambers D, Khoury MJ, Kaplan RM, Hunter C. National Institutes of Health approaches to dissemination and implementation science: current and future directions. Am J Public Health. 2012 Jul;102(7):1274-81. doi: 10.2105/AJPH.2012.300755. Epub 2012 May 17.</citation>
    <PMID>22594758</PMID>
  </reference>
  <reference>
    <citation>World Health Organization (WHO). BMI classification. 2006 Available at: http://apps.who.int/bmi/index.jsp?introPage=intro_3.html [Accessed on October 18, 2017]</citation>
  </reference>
  <reference>
    <citation>Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27.</citation>
    <PMID>11183293</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Arizona</investigator_affiliation>
    <investigator_full_name>Melanie Hingle</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Nutritional Sciences</investigator_title>
  </responsible_party>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Diabetes Prevention</keyword>
  <keyword>Prediabetes Intervention</keyword>
  <keyword>Mothers</keyword>
  <keyword>Children</keyword>
  <keyword>Federally Qualified Health Center (FQHC) Program</keyword>
  <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>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03781102
org study id: 1R34DK118486-01
nct id: NCT03781102
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The two main questions that this research study will answer:

        1. will a 16-week community-based diabetes prevention program for delivery to at-risk
           mothers and children in a Federally Qualified Health Center (FQHC) setting show (a) pre-
           and post-intervention improvements to Type 2 Diabetes risk factors in 60 mother-child
           dyads; (b) intervention vs. control improvements to T2D risk factors in 30 mother-child
           dyads; and (c) maintenance effects to changes to Type 2 Diabetes risk factors in 30
           mother-child dyads; and

        2. based on the acceptability, adoption, relevance to FQHC and participants, feasibility,
           fidelity, program costs, and factors influencing sustainability of this program, can it
           be disseminated nationwide to other FQHC's?

      The investigators hypothesize that participants (a) will show improvements following the
      intervention to T2D risk factors, (b) in the intervention will show significant improvements
      to T2D risk factors in versus the controls, and (c) will maintain the benefits beyond the
      16-week intervention. The investigators also predict that this program will meet criteria to
      be disseminated nationwide to other FQHC's.
The goal is to implement and evaluate the effects of a 16-week behavioral lifestyle
      intervention on Type 2 Diabetes (T2D) risk factors delivered by trained staff at a Federally
      Qualified Health Center (FQHC) to 60 mothers with prediabetes or a history of gestational
      diabetes (GDM) and 60 overweight/obese children. The specific aims are to (1) adapt an
      efficacious community-based diabetes prevention program for delivery to FQHC patients, (2)
      evaluate indicators of program implementation and potential for dissemination (Proctor 2011),
      and (3) assess the preliminary impact of the program on participants' T2D risk factors.

      The study aims to adapt an efficacious community-based diabetes prevention program developed
      for delivery to at-risk mothers and children at a FQHC. Successful T2D prevention in children
      necessitates family adoption of lifestyle behaviors associated with prevention of excess
      weight gain, while supporting normal growth and development. In accord with the 2012
      Institute of Medicine Report (IOM 2012) and guidelines set forth by an Expert Committee
      (Barlow 2007), three healthy lifestyle goals form the basis for youth-focused aspects of the
      intervention: i) make physical activity an integral and routine part of life; ii) eat a
      healthy diet (both quality and quantity), and, iii) create food and physical activity
      environments to insure healthy options and behaviors are the routine, easy choice. These
      goals align with two evidence-based T2D prevention goals mothers will be encouraged to adopt:
      i) lose 7% of body weight through healthy eating, and ii) participate in at least 150 minutes
      of moderate-to-vigorous physical activity each week. Achievement of these goals has been
      associated with significant T2D risk reduction in participants of programs based on the
      Centers for Disease Control and Prevention (CDC) National Diabetes Prevention Program (CDC
      2017, Albright 2013). The intervention duration, content, and activities, designed to support
      families in meeting these recommendations, were drawn from the intervention literature
      (Wilfley 2010, Epstein 2007, Ackermann 2008, Hingle 2015). Intervention "dose" (duration ×
      time) was modeled after the successful adult-focused DPP/YDPP (characterized by 16 core
      sessions) and the recently released 2017 U.S. Preventive Services Task Force (USPSTF)
      evidence-based recommendations for weight loss, behavior change, and cardio-metabolic risk
      reduction in youth (O'Connor 2017). The topics are focused on practical, culturally-relevant
      strategies for modifying the behaviors associated with the pathogenesis of T2D in youth
      (Spruijt-Metz 2014) (e.g., availability and accessibility of nutrient- and calorie-dense
      foods and food preparation strategies in the home, reducing intake of sugar-sweetened
      beverages, increasing time spent in physical activity/decreasing time spent in sedentary
      activities, stress management, and obtaining quality sleep), while engaging participants in
      fun, active, and interactive food demonstrations, energy balance, and physical activities
      appropriate for the entire family. All sessions are group-based (attended by up to 10
      families total) and led by a minimum of two trained bilingual FQHC health and wellness staff.
      The sessions will be approximately 1.5-2 hours in length and conducted over 16 consecutive
      weeks at one of two FQHC locations. The sessions foster skill building and provide repeated
      opportunities to practice healthy lifestyle behaviors. Each session will follow a similar
      format consisting of: (1) a featured physical activity encouraging families to get moving
      upon arrival; (2) small group discussions focused on goal-setting and building intra- and
      inter-family camaraderie; (3) hands-on food preparation and tasting opportunities centered
      around vegetables, whole grains, and legumes; (4) low- to no-cost fun family physical
      activities (on alternating weeks, mothers will participate in a moderated discussion on
      proactive parenting); (5) energy balance activities (e.g. label reading) to increase
      foundational knowledge and skills related to healthy food selection, physical activity
      benefits, and creating a supportive home environment; and, (6) opportunities to set new
      weekly goals (or revise previous goals).

      The second aim evaluates program implementation outcomes including acceptability, adoption,
      relevance to FQHC and participants, feasibility, fidelity, program costs, and factors
      influencing sustainability. Consistent with the tenets of implementation science (Glasgow
      2012), these variables are assessed at recommended time points (Proctor 2011) to insure all
      aspects of the intervention work as intended, including participant acceptability
      (participant satisfaction) and relevance to FQHC personnel and study participants (rated
      using brief surveys of the relevance of the intervention to daily life, promoters and
      barriers to program attendance and engagement, the degree to which families report using the
      intervention to guide behavioral choices, and surveys of lifestyle coaches trained to deliver
      the intervention). The investigators also assess adoption by the FQHC and integration with
      the existing clinical setting (ascertained through semi-structured interviews with FQHC
      wellness staff and administrators exploring 'fit' among existing program offerings,
      availability of personnel and resources needed to implement, and potential for reimbursement)
      and feasibility (of delivery by providers and FQHC determined by recruitment, enrollment, and
      retention rates, adherence data including session attendance and observed participant
      engagement with intervention activities; a brief, three-question interview will be conducted
      with every eligible respondent who elects not to participate). Fidelity is assessed through
      observation of research staff following an established rubric, and program costs are
      evaluated using a bottom-up micro-costing approach (for participants, surveys assessing cost,
      burden, and benefit such as time and resources spent in travel, services, equipment, and food
      to meet program recommendations; FQHC direct medical and non-medical costs including
      personnel gross hourly salaries, intervention material costs, and overhead costs related to
      use of facilities for prevention services are tracked and analyzed in partnership with FQHC
      data team members). The investigators also explore the potential for replication and
      dissemination using semi-structured interviews with the FQHC wellness staff assigned to
      coordinate and deliver the program, and administrators and advisory board members who
      understand how to align the intervention with the FQHC's fiscal and strategic plans, and who
      have relationships with other FQHCs in Arizona and nationally. Program sustainability is also
      of great interest to the FQHC, thus our a priori focus on factors influencing sustainability
      (e.g., reach, integration with other health/wellness programs, institutionalization) beyond
      the research funding period are a major consideration throughout the proposed study. At the
      conclusion of the proposed work, this evaluation is designed to produce an intervention
      curriculum and approach suitable for replication and scaling across a larger number of
      (cluster-randomized) FQHC sites.

      The third aim is to assess the preliminary efficacy of the program on T2D risk factors
      including weight status, metabolic syndrome phenotype, lifestyle behaviors, and
      socio-environmental determinants of health outcomes in 60 mothers and 60 children
      participating in the 16-week intervention. Intervention participants are measured at Week 0
      (baseline), Week 16 (post-intervention), and Week 32 (maintenance) and wait-listed control
      participants at Week 0 (baseline), Week 16 (follow-up and pre-intervention), and Week 32
      (post-intervention). Measurements are conducted by trained research staff following
      standardized measurement procedures, and take place at the FQHC site to which the child and
      parent is assigned. Care is taken to avoid simultaneous scheduling of intervention and
      wait-listed control families.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants (60 children and their biological mothers (n=120)) will be assigned to a clinic location nearest to their home address, which will determine the order in which they will complete the 16-week intervention. Two clinics were selected to participate in this pilot study. Randomization to the intervention and wait-list control conditions will be performed *by site* (flip of a coin). Randomization by site is proposed as it has the least potential for contamination during the initial delivery period. Group A participants (n=30) will begin the 16-week face-to-face group program immediately, whereas the Group B participants (n=30) will receive normal standard of care. After 16 weeks, the Group A participants will transition to follow-up while the Group B participants begin the intervention. This design is responsive to standards of care for T2D prevention by primary care providers and will provide the opportunity to investigate all the outcome questions.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Body Weight
time frame: Baseline, Week 16, Week 32
description: Body weight (kg) is measured using a calibrated, Cardinal Detecto ProDoc Series PD300MHR Digital Physician scale and a Cardinal Detecto 758C Weight Indicator
measure: Change in Body Height
time frame: Baseline, Week 16, Week 32
description: Body height (cm) measured using a calibrated, Cardinal Detecto ProDoc Series PD300MHR Digital Physician scale with a mechanical height rod and a Cardinal Detecto 758C Weight Indicator with a Seca 213 Portable Stadiometer.
measure: Change in Body Mass Index (BMI)
time frame: Baseline, Week 16, Week 32
description: BMI (kg/m2) is categorized using international classifications of BMI (overweight, 25-29.9kg/m2; obese, >30kg/m2) (WHO 2006).
measure: Change in Body Mass Index (BMI) Percentile
time frame: Baseline, Week 16, Week 32
description: BMI percentile in children is determined using age- and sex-specific growth charts developed by the CDC in 2000 (Kuczmarski 2000).
measure: Change in Waist Circumference
time frame: Baseline, Week 16, Week 32
description: Child and adult waist circumferences are measured at the umbilicus. All measures are completed in duplicate, and the average of the two measures is used.
measure: Change in Blood Pressure
time frame: Baseline, Week 16, Week 32
description: Blood pressure assessed with an aneroid sphygmomanometer and with a Mindray Accutorr V vital signs monitor with an appropriate-sized cuff after participants are seated and relaxed for at least 5 minutes.
measure: Change in HbA1C
time frame: Baseline, Week 16, Week 32
description: HbA1C as assessed using a finger stick sample will be collected using a Siemens Diagnostics DCA HbA1C analyzer.
measure: Change in Total Cholesterol / HDL-cholesterol
time frame: Baseline, Week 16, Week 32
description: Total Cholesterol and HDL-cholesterol as assessed using a finger stick sample will be measured using a Cholestech LDX® lipid analyzer.
measure: Change in Dietary Intake (daily eating patterns)
time frame: Baseline, Week 16, Week 32
description: Dietary Intake - Child - assessed with interviewer-administered 24-hr dietary recalls. Parent- assessed using Arizona Food Frequency Questionnaire (AFFQ).
measure: Change in Moderate to vigorous physical activity (MVPA) and sedentary behavior
time frame: Baseline, Week 16, Week 32
description: MVPA and sedentary behavior - Child - assessed using the Youth Activity Profile (YAP). Parent - assessed using the Arizona Activity Frequency Questionnaire (AAFQ).
measure: Change in sleep behavior (daily sleeping patterns)
time frame: Baseline, Week 16, Week 32
description: Sleep Behavior - Child - assessed using the Children's Sleep Habits Questionnaire, Abbreviated. Adult - N/A
measure: Change in home food and physical activity environment
time frame: Baseline, Week 16, Week 32
description: Home food and physical activity environment - assessed using the Family Nutrition and Physical Activity Tool (FNPA).
measure: Change in demographic and social and environmental risk factors for T2D
time frame: Baseline, Week 16, Week 32
description: Demographic and social and environmental risk factors for T2D will be assessed using the Sangre Por Salud Biobank Health Questionnaire.
arm group label: Intervention
arm group type: Experimental
description: Arm 1, or intervention participants (n=60), will participate in a 16-week face-to-face diabetes prevention group program '16-Week Diabetes Prevention Program for Mothers and Children' and then will transition to a 16-week follow-up period.
arm group label: Wait-listed Control
arm group type: Other
description: Arm 2, or wait-listed controls (n=60), will receive the typical standard of care during the first 16-weeks, followed by the 16-week face-to-face group diabetes prevention program '16-Week Diabetes Prevention Program for Mothers and Children'.
intervention type: Behavioral
intervention name: 16-Week Diabetes Prevention Program for Mothers and Children
description: The 16-week intervention is focused on ways to modify behaviors associated with the pathogenesis of Type 2 Diabetes in youth, while engaging participants in fun, active, and interactive food demonstrations, energy balance, and physical activities appropriate for all the family. Weekly sessions will consist of: (1) physical activity upon arrival; (2) small group discussions; (3) hands-on food preparation and tasting opportunities; (4) low- to no-cost fun family physical activities; (5) energy balance activities (e.g. label reading) to increase foundational knowledge; and, (6) opportunities to set new weekly goals.
arm group label: Intervention
arm group label: Wait-listed Control
criteria: 
gender: All
minimum age: 8 Years
maximum age: 54 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melanie D Hingle, PhD
role: Principal Investigator
affiliation: University of Arizona
last name: David G Marrero, PhD
role: Principal Investigator
affiliation: University of Arizona
facility: 
country: United States
citation: Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PMID: 20957426
citation: Committee on Accelerating Progress in Obesity Prevention; Food and Nutrition Board; Institute of Medicine; Glickman D, Parker L, Sim LJ, Del Valle Cook H, Miller EA, editors. Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation. Washington (DC): National Academies Press (US); 2012 May 8. Available from http://www.ncbi.nlm.nih.gov/books/NBK201141/
PMID: 24830053
citation: Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
PMID: 18055651
citation: Centers for Disease Control and Prevention. National Diabetes Prevention Program 2017. Available at: https://www.cdc.gov/diabetes/prevention/index.html [Accessed on October 18, 2017]
citation: Albright AL, Gregg EW. Preventing type 2 diabetes in communities across the U.S.: the National Diabetes Prevention Program. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S346-51. doi: 10.1016/j.amepre.2012.12.009.
PMID: 23498297
citation: Wilfley DE, Vannucci A, White EK. Early intervention of eating- and weight-related problems. J Clin Psychol Med Settings. 2010 Dec;17(4):285-300. doi: 10.1007/s10880-010-9209-0.
PMID: 20960039
citation: Epstein LH, Paluch RA, Roemmich JN, Beecher MD. Family-based obesity treatment, then and now: twenty-five years of pediatric obesity treatment. Health Psychol. 2007 Jul;26(4):381-91. doi: 10.1037/0278-6133.26.4.381.
PMID: 17605557
citation: Ackermann RT, Finch EA, Brizendine E, Zhou H, Marrero DG. Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. Am J Prev Med. 2008 Oct;35(4):357-63. doi: 10.1016/j.amepre.2008.06.035.
PMID: 18779029
citation: Hingle MD, Turner T, Kutob R, Merchant N, Roe DJ, Stump C, Going SB. The EPIC Kids Study: a randomized family-focused YMCA-based intervention to prevent type 2 diabetes in at-risk youth. BMC Public Health. 2015 Dec 18;15:1253. doi: 10.1186/s12889-015-2595-3.
PMID: 26679186
citation: O'Connor EA, Evans CV, Burda BU, Walsh ES, Eder M, Lozano P. Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017 Jun 20;317(23):2427-2444. doi: 10.1001/jama.2017.0332.
PMID: 28632873
citation: Spruijt-Metz D, O'Reilly GA, Cook L, Page KA, Quinn C. Behavioral contributions to the pathogenesis of type 2 diabetes. Curr Diab Rep. 2014 Apr;14(4):475. doi: 10.1007/s11892-014-0475-3.
PMID: 24604714
citation: Glasgow RE, Vinson C, Chambers D, Khoury MJ, Kaplan RM, Hunter C. National Institutes of Health approaches to dissemination and implementation science: current and future directions. Am J Public Health. 2012 Jul;102(7):1274-81. doi: 10.2105/AJPH.2012.300755. Epub 2012 May 17.
PMID: 22594758
citation: World Health Organization (WHO). BMI classification. 2006 Available at: http://apps.who.int/bmi/index.jsp?introPage=intro_3.html [Accessed on October 18, 2017]
citation: Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27.
PMID: 11183293
responsible party type: Principal Investigator
investigator affiliation: University of Arizona
investigator full name: Melanie Hingle
investigator title: Assistant Professor, Department of Nutritional Sciences
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: Undecided