Med-South Lifestyle Program Implementation Study

Scaling up the Med-South Lifestyle Program to Reduce Chronic Disease in Partnership With Rural Communities: Phase 2

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Lifestyle
• Intervention / Treatment: Behavioral: Med-South Lifestyle Program

Detailed Description

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 Prevention with Mediterranean Diet (PREDIMED) 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 2, the investigators will apply an effectiveness-implementation hybrid design to compare two formats for scaling up MSLP on implementation outcomes (primary aim) and confirm the MSLP's impact on behavioral and clinical outcomes (secondary aim).

Participants: Phase II participants include: staff at 20 rural North Carolina sites (10 health departments and 10 federally qualified health centers) and participants from each site (15 each, 300 total)

Procedures (methods): Test the effects of scaling up MSLP using two different formats. Using an effectiveness-implementation hybrid Type 3 design, the investigators will randomize 20 sites (10 health departments and 10 Federally Qualified Health Centers (FQHCs)) to 1 of 2 formats for delivering scale up strategies: distance (webinar and phone) vs. a blended in-person/distance collaborative format. Each site will collect data on 15 patients (n=300).

Aim 1: Site level: compare the relative effects of the 2 scale-up formats on implementation outcomes (reach, acceptability, feasibility, fidelity, and cost).

Aim 2: Participant-level: assess changes in behavioral and clinical outcomes: (1) self-reported diet and physical activity and (2) weight from baseline to follow-up (4 and 10 months). Compare outcomes across the 2 scale-up delivery formats.

• Study Type: Interventional
• Enrollment (Actual): 368
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female
• English speaking (Spanish-speaking only in selected sites with bilingual staff)
• Ages 18-80

Exclusion Criteria:

• Malignancy
• Advanced kidney disease (estimated creatinine clearance < 30 mL/min)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Distance Scale-Up Format; 10 sites with up to 150 program participants will be randomly assigned to a distance scale-up format where each site implementation team will receive technical assistance individually. All implementation training will occur using a virtual web-based format. Implementation teams will receive 8 hours of web-conferences, 2 hours of online training, and 4 hours of technical assistance.	Behavioral: Med-South Lifestyle Program; The Med-South Lifestyle Program (MSLP) 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. To promote healthy dietary intake and increased physical activity, the intervention incorporates theory-based behavioral approaches targeting self-efficacy, self-regulation, and internal motivation. The MSLP is delivered in 4 monthly counseling sessions with 3 interim phone follow-up contacts. A maintenance phase lasting 6 months follows the 4-month MSLP and includes 2 phone contacts about 2 months apart. Participants are counseled individually, with 2 in-person counseling visits (at the 1st and 4th counseling visit) and 5 total phone contacts. Each participant is provided with program materials in a participant manual, a cookbook, and a local resource manual identifying community resources to support making targeted behavior changes.; Other Names: Med-South Program
Experimental: Quality Improvement Collaborative Scale-Up Format; 10 sites with up to 150 program participants will be randomly assigned to a quality improvement collaborative scale-up format where implementation teams will work collaboratively during training and implementation. All implementation training will occur using a virtual web-based format. Implementation teams will receive 8 hours of web-conferences, 2 hours of online training, and 4 hours of technical assistance.	Behavioral: Med-South Lifestyle Program; The Med-South Lifestyle Program (MSLP) 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. To promote healthy dietary intake and increased physical activity, the intervention incorporates theory-based behavioral approaches targeting self-efficacy, self-regulation, and internal motivation. The MSLP is delivered in 4 monthly counseling sessions with 3 interim phone follow-up contacts. A maintenance phase lasting 6 months follows the 4-month MSLP and includes 2 phone contacts about 2 months apart. Participants are counseled individually, with 2 in-person counseling visits (at the 1st and 4th counseling visit) and 5 total phone contacts. Each participant is provided with program materials in a participant manual, a cookbook, and a local resource manual identifying community resources to support making targeted behavior changes.; Other Names: Med-South Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eligible Patients Participating	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.	Month 10
Percentage of Med-South Lifestyle Program Delivered as Intended	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.	Month 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Number of Fruit and Vegetable Servings Per Day	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.	Month 0, Month 10
Mean Change in Minutes of Physical Activity Per Week	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.	Month 0, Month 10
Mean Percent Change in Weight	Mean weight change (in kg) from baseline to follow-up expressed as a percentage of baseline weight	Month 0, Month 10
Mean Change in Systolic Blood Pressure at end of 4-Month Med-South Program	Mean difference in systolic blood pressure measured at session 1 and at the end of the Med-south Program (session 4).	Month 0, Month 4
Mean Change in Systolic Blood Pressure at end of 6-Month Maintenance Phase	Mean difference in systolic blood pressure measured at session 4 of the Med-South Program and at the end of the maintenance phase (month 10).	Month 4, Month 10
Mean Change in Diastolic Blood Pressure at end of 4-Month Med-South Program	Mean difference in diastolic blood pressure measured at session 1 and at the end of the Med-South Program (session 4).	Month 0, Month 4
Mean Change in Diastolic Blood Pressure at end of 6-Month Maintenance Phase	Mean difference in diastolic blood pressure measured at session 4 of the Med-South Program and at the end of the maintenance phase (month 10).	Month 4, Month 10

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Carmen Samuel-Hodge, PhD, University of North Carolina, Chapel Hill; Principal Investigator: Jennifer Leeman, DrPH, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• The current study will adapt intervention and dissemination materials from the CHANGE Study.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Estimated): September 29, 2024
• Study Completion (Estimated): September 29, 2024

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-1281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: Investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No