<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/NCT04421703</url>
  </required_header>
  <id_info>
    <org_study_id>19-2079</org_study_id>
    <nct_id>NCT04421703</nct_id>
  </id_info>
  <brief_title>Med-South Lifestyle Study: Phase 1</brief_title>
  <official_title>Scaling up the Med-South Lifestyle Program to Reduce Chronic Disease in Partnership With Rural Communities: Phase 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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 purpose of this study is to determine the processes by which a previously proven&#xD;
      lifestyle intervention (the Med-South Lifestyle Program) can most effectively and efficiently&#xD;
      be translated into public health and clinical practice to positively impact chronic disease&#xD;
      risk reduction among mostly minority, rural, and medically underserved populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: Although lifestyle behavior change interventions are widely recommended to improve&#xD;
      health, they are not being implemented sufficiently or equitably on a national scale,&#xD;
      particularly in rural communities. The research team has developed and tested multiple&#xD;
      lifestyle interventions, which have culminated in the Med-South Lifestyle Program (MSLP), an&#xD;
      evidence-based behavior change intervention that translates the PREDIMED (Mediterranean)&#xD;
      dietary pattern for a Southeastern US population and includes support for increased physical&#xD;
      activity. In this research the investigators propose to identify the most effective and&#xD;
      efficient way to scale-up the MSLP for use in public health and clinical practices settings&#xD;
      so that it reaches minority, rural, and medically underserved populations.&#xD;
&#xD;
      In Phase 1, the investigators will develop, pilot test, and refine implementation strategies&#xD;
      that will be used to take the MSLP to scale.&#xD;
&#xD;
      Participants: Phase I participants include up to 80 participants who will receive the MSLP&#xD;
      and for whom the study team will collect baseline and follow-up data.&#xD;
&#xD;
      Procedures (methods): An evidence-based framework for scaling-up health interventions will be&#xD;
      used to guide Phase I activities. The initial phase involves refining the &quot;scalable unit&quot;&#xD;
      which includes the lifestyle program (MSLP), implementation strategies for the sites that&#xD;
      will give the program, and strategies UNC will use to train sites on implementing the&#xD;
      program. To refine the scalable unit the investigators will apply a descriptive, qualitative&#xD;
      design to assess the feasibility and acceptability of the MSLP's intervention and&#xD;
      implementation strategies (i.e., what the investigators will scale-up in Phases 2 and 3). In&#xD;
      Phase 1, the study team will recruit 2 local health departments and 2 federally qualified&#xD;
      health centers as participating sites. Each site will form an implementation team of 2-4&#xD;
      individuals who will go through training on intervention delivery and implementation. Sites&#xD;
      will be randomized to receive training either through a distance (webinar) or&#xD;
      in-person/collaborative format. Each site will recruit up to 20 participants (for a total of&#xD;
      80 across all sites) to receive the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Actual">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Eligible Patients Participating</measure>
    <time_frame>Month 6</time_frame>
    <description>Percentage of each setting's eligible patients who participate in the Med-South Lifestyle Program and the representativeness of participants (age, gender, race/ethnicity) as compared to overall population of eligible patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Med-South Lifestyle Program Delivered as Intended</measure>
    <time_frame>Month 6</time_frame>
    <description>To determine delivery fidelity, the study team will measure the degree to which the intervention is delivered as intended as assessed by direct observations and audio file reviews documented by checklist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change Number of Fruit and Vegetable Servings Per Day</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>The mean difference in fruit and vegetable servings per day (baseline servings/day - follow-up servings/day) as measured by the Block Fruit-Vegetable-Fiber Screener.&#xD;
The Block Fruit-Vegetable-Fiber Screener is a 10-item scale with responses ranging from: (1) Less than 1/week to (5) 2+ a day. Higher scores reflect a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Minutes of Physical Activity Per Week</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Mean difference in minutes of physical activity per week (baseline activity in minutes/week - follow-up activity in minutes/week) as measured by the validated modified RESIDE questionnaire. The RESIDE questionnaire is a 21-item self-administered instrument in which participants recall the frequency, duration, and destination of their walking (for transport and recreation) within and outside of their neighborhood, and cycling activity in a usual week. Higher scores indicate more minutes of activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Percent Change in Weight</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Mean weight change (in kg) from baseline to follow-up expressed as a percentage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy Lifestyle</condition>
  <arm_group>
    <arm_group_label>Distance Collaborative</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For sites randomized to the distance arm, training will be delivered via web conference, and technical assistance and assessment and feedback will be delivered by phone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blended in-person/distance collaborative</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the QI collaborative arm, training will be delivered in two in-person collaborative meetings; and the remainder of the strategies will be delivered via web-conferencing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Med-South Lifestyle Program</intervention_name>
    <description>The Med-South Lifestyle Program is an evidence-based behavior change intervention that translates the PREDIMED (Mediterranean) dietary pattern for a Southeastern US population and includes support for increased physical activity.</description>
    <arm_group_label>Blended in-person/distance collaborative</arm_group_label>
    <arm_group_label>Distance Collaborative</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Ages 18-80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Advanced kidney disease (estimated creatinine clearance &lt; 30 mL/min)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmen Samuel-Hodge, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Leeman, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rural Health Group</name>
      <address>
        <city>Norlina</city>
        <state>North Carolina</state>
        <zip>27563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Granville-Vance Public Health</name>
      <address>
        <city>Oxford</city>
        <state>North Carolina</state>
        <zip>27565</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Person Family Medical Center</name>
      <address>
        <city>Roxboro</city>
        <state>North Carolina</state>
        <zip>27573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://change.web.unc.edu/</url>
    <description>The current study will adapt intervention and dissemination materials from the CHANGE Study.</description>
  </link>
  <reference>
    <citation>Samuel-Hodge CD, Gizlice Z, Allgood SD, Bunton AJ, Erskine A, Leeman J, Cykert S. Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study. BMC Public Health. 2020 Feb 21;20(1):264. doi: 10.1186/s12889-020-8223-x.</citation>
    <PMID>32085707</PMID>
  </reference>
  <reference>
    <citation>Leeman J, Calancie L, Hartman MA, Escoffery CT, Herrmann AK, Tague LE, Moore AA, Wilson KM, Schreiner M, Samuel-Hodge C. What strategies are used to build practitioners' capacity to implement community-based interventions and are they effective?: a systematic review. Implement Sci. 2015 May 29;10:80. doi: 10.1186/s13012-015-0272-7.</citation>
    <PMID>26018220</PMID>
  </reference>
  <reference>
    <citation>Keyserling TC, Samuel-Hodge CD, Pitts SJ, Garcia BA, Johnston LF, Gizlice Z, Miller CL, Braxton DF, Evenson KR, Smith JC, Davis GB, Quenum EL, Elliott NT, Gross MD, Donahue KE, Halladay JR, Ammerman AS. A community-based lifestyle and weight loss intervention promoting a Mediterranean-style diet pattern evaluated in the stroke belt of North Carolina: the Heart Healthy Lenoir Project. BMC Public Health. 2016 Aug 5;16:732. doi: 10.1186/s12889-016-3370-9.</citation>
    <PMID>27495295</PMID>
  </reference>
  <reference>
    <citation>Cubillos L, Estrada Del Campo Y, Harbi K, Keyserling T, Samuel-Hodge C, Reuland DS. Feasibility and Acceptability of a Clinic-based Mediterranean-style Diet Intervention to Reduce Cardiovascular Risk for Hispanic Americans With Type 2 Diabetes. Diabetes Educ. 2017 Jun;43(3):286-296. doi: 10.1177/0145721717706030. Epub 2017 Apr 21.</citation>
    <PMID>28427311</PMID>
  </reference>
  <reference>
    <citation>Thomas T, Samuel-Hodge CD, Porterfield DS, Alva ML, Leeman J. Scaling Up Diabetes Prevention Programs in North Carolina: Perceptions of Demand From Potential Program Recipients and Providers. Diabetes Educ. 2019 Feb;45(1):116-124. doi: 10.1177/0145721718811564. Epub 2018 Nov 9. No abstract available.</citation>
    <PMID>30413136</PMID>
  </reference>
  <reference>
    <citation>Rohweder C, Wangen M, Black M, Dolinger H, Wolf M, O'Reilly C, Brandt H, Leeman J. Understanding quality improvement collaboratives through an implementation science lens. Prev Med. 2019 Dec;129S:105859. doi: 10.1016/j.ypmed.2019.105859. Epub 2019 Oct 23.</citation>
    <PMID>31655174</PMID>
  </reference>
  <reference>
    <citation>Leeman J, Toles M. What does it take to scale-up a complex intervention? Lessons learned from the Connect-Home transitional care intervention. J Adv Nurs. 2020 Jan;76(1):387-397. doi: 10.1111/jan.14239. Epub 2019 Nov 20.</citation>
    <PMID>31642091</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>February 22, 2022</last_update_submitted>
  <last_update_submitted_qc>February 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04421703
org study id: 19-2079
nct id: NCT04421703
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the processes by which a previously proven
      lifestyle intervention (the Med-South Lifestyle Program) can most effectively and efficiently
      be translated into public health and clinical practice to positively impact chronic disease
      risk reduction among mostly minority, rural, and medically underserved populations.
Purpose: Although lifestyle behavior change interventions are widely recommended to improve
      health, they are not being implemented sufficiently or equitably on a national scale,
      particularly in rural communities. The research team has developed and tested multiple
      lifestyle interventions, which have culminated in the Med-South Lifestyle Program (MSLP), an
      evidence-based behavior change intervention that translates the PREDIMED (Mediterranean)
      dietary pattern for a Southeastern US population and includes support for increased physical
      activity. In this research the investigators propose to identify the most effective and
      efficient way to scale-up the MSLP for use in public health and clinical practices settings
      so that it reaches minority, rural, and medically underserved populations.

      In Phase 1, the investigators will develop, pilot test, and refine implementation strategies
      that will be used to take the MSLP to scale.

      Participants: Phase I participants include up to 80 participants who will receive the MSLP
      and for whom the study team will collect baseline and follow-up data.

      Procedures (methods): An evidence-based framework for scaling-up health interventions will be
      used to guide Phase I activities. The initial phase involves refining the "scalable unit"
      which includes the lifestyle program (MSLP), implementation strategies for the sites that
      will give the program, and strategies UNC will use to train sites on implementing the
      program. To refine the scalable unit the investigators will apply a descriptive, qualitative
      design to assess the feasibility and acceptability of the MSLP's intervention and
      implementation strategies (i.e., what the investigators will scale-up in Phases 2 and 3). In
      Phase 1, the study team will recruit 2 local health departments and 2 federally qualified
      health centers as participating sites. Each site will form an implementation team of 2-4
      individuals who will go through training on intervention delivery and implementation. Sites
      will be randomized to receive training either through a distance (webinar) or
      in-person/collaborative format. Each site will recruit up to 20 participants (for a total of
      80 across all sites) to receive the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Eligible Patients Participating
time frame: Month 6
description: Percentage of each setting's eligible patients who participate in the Med-South Lifestyle Program and the representativeness of participants (age, gender, race/ethnicity) as compared to overall population of eligible patients.
measure: Percentage of Med-South Lifestyle Program Delivered as Intended
time frame: Month 6
description: To determine delivery fidelity, the study team will measure the degree to which the intervention is delivered as intended as assessed by direct observations and audio file reviews documented by checklist.
measure: Mean Change Number of Fruit and Vegetable Servings Per Day
time frame: Baseline, Month 6
description: The mean difference in fruit and vegetable servings per day (baseline servings/day - follow-up servings/day) as measured by the Block Fruit-Vegetable-Fiber Screener.
The Block Fruit-Vegetable-Fiber Screener is a 10-item scale with responses ranging from: (1) Less than 1/week to (5) 2+ a day. Higher scores reflect a better outcome.
measure: Mean Change in Minutes of Physical Activity Per Week
time frame: Baseline, Month 6
description: Mean difference in minutes of physical activity per week (baseline activity in minutes/week - follow-up activity in minutes/week) as measured by the validated modified RESIDE questionnaire. The RESIDE questionnaire is a 21-item self-administered instrument in which participants recall the frequency, duration, and destination of their walking (for transport and recreation) within and outside of their neighborhood, and cycling activity in a usual week. Higher scores indicate more minutes of activity.
measure: Mean Percent Change in Weight
time frame: Baseline, Month 6
description: Mean weight change (in kg) from baseline to follow-up expressed as a percentage.
arm group label: Distance Collaborative
arm group type: Experimental
description: For sites randomized to the distance arm, training will be delivered via web conference, and technical assistance and assessment and feedback will be delivered by phone.
arm group label: Blended in-person/distance collaborative
arm group type: Experimental
description: For the QI collaborative arm, training will be delivered in two in-person collaborative meetings; and the remainder of the strategies will be delivered via web-conferencing.
intervention type: Behavioral
intervention name: Med-South Lifestyle Program
description: The Med-South Lifestyle Program is an evidence-based behavior change intervention that translates the PREDIMED (Mediterranean) dietary pattern for a Southeastern US population and includes support for increased physical activity.
arm group label: Blended in-person/distance collaborative
arm group label: Distance Collaborative
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carmen Samuel-Hodge, PhD
role: Principal Investigator
affiliation: UNC Chapel Hill
last name: Jennifer Leeman, DrPH
role: Principal Investigator
affiliation: UNC Chapel Hill
facility: 
facility: 
facility: 
country: United States
url: http://change.web.unc.edu/
description: The current study will adapt intervention and dissemination materials from the CHANGE Study.
citation: Samuel-Hodge CD, Gizlice Z, Allgood SD, Bunton AJ, Erskine A, Leeman J, Cykert S. Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study. BMC Public Health. 2020 Feb 21;20(1):264. doi: 10.1186/s12889-020-8223-x.
PMID: 32085707
citation: Leeman J, Calancie L, Hartman MA, Escoffery CT, Herrmann AK, Tague LE, Moore AA, Wilson KM, Schreiner M, Samuel-Hodge C. What strategies are used to build practitioners' capacity to implement community-based interventions and are they effective?: a systematic review. Implement Sci. 2015 May 29;10:80. doi: 10.1186/s13012-015-0272-7.
PMID: 26018220
citation: Keyserling TC, Samuel-Hodge CD, Pitts SJ, Garcia BA, Johnston LF, Gizlice Z, Miller CL, Braxton DF, Evenson KR, Smith JC, Davis GB, Quenum EL, Elliott NT, Gross MD, Donahue KE, Halladay JR, Ammerman AS. A community-based lifestyle and weight loss intervention promoting a Mediterranean-style diet pattern evaluated in the stroke belt of North Carolina: the Heart Healthy Lenoir Project. BMC Public Health. 2016 Aug 5;16:732. doi: 10.1186/s12889-016-3370-9.
PMID: 27495295
citation: Cubillos L, Estrada Del Campo Y, Harbi K, Keyserling T, Samuel-Hodge C, Reuland DS. Feasibility and Acceptability of a Clinic-based Mediterranean-style Diet Intervention to Reduce Cardiovascular Risk for Hispanic Americans With Type 2 Diabetes. Diabetes Educ. 2017 Jun;43(3):286-296. doi: 10.1177/0145721717706030. Epub 2017 Apr 21.
PMID: 28427311
citation: Thomas T, Samuel-Hodge CD, Porterfield DS, Alva ML, Leeman J. Scaling Up Diabetes Prevention Programs in North Carolina: Perceptions of Demand From Potential Program Recipients and Providers. Diabetes Educ. 2019 Feb;45(1):116-124. doi: 10.1177/0145721718811564. Epub 2018 Nov 9. No abstract available.
PMID: 30413136
citation: Rohweder C, Wangen M, Black M, Dolinger H, Wolf M, O'Reilly C, Brandt H, Leeman J. Understanding quality improvement collaboratives through an implementation science lens. Prev Med. 2019 Dec;129S:105859. doi: 10.1016/j.ypmed.2019.105859. Epub 2019 Oct 23.
PMID: 31655174
citation: Leeman J, Toles M. What does it take to scale-up a complex intervention? Lessons learned from the Connect-Home transitional care intervention. J Adv Nurs. 2020 Jan;76(1):387-397. doi: 10.1111/jan.14239. Epub 2019 Nov 20.
PMID: 31642091
responsible party type: Sponsor
sharing ipd: No