Med-South Lifestyle Program Implementation Study

NCT05067816 | Completed

• 1 other identifier: 21-1281
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Lifestyle

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Mean Change in Number of Fruit and Vegetable Servings Per Day

  Month 0, Month 10

• Mean Change in Minutes of Physical Activity Per Week

  Month 0, Month 10

• Mean Percent Change in Weight

  Month 0, Month 10

• Mean Change in Systolic Blood Pressure at end of 4-Month Med-South Program

  Month 0, Month 4

• Mean Change in Systolic Blood Pressure at end of 6-Month Maintenance Phase

  Month 4, Month 10

Study Arms (2)

Distance Scale-Up Format

ACTIVE COMPARATOR

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

Quality Improvement Collaborative Scale-Up Format

EXPERIMENTAL

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

Interventions

Med-South Lifestyle Program BEHAVIORAL

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.

Also known as: Med-South Program

Distance Scale-Up Format; Quality Improvement Collaborative Scale-Up Format

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Samuel-Hodge CD, Pham L, Lyons K, Draeger LB, Jiang L, Lin FC, Ram R, Leeman J. Scaling up the Med-South Lifestyle Program in public health settings to reduce chronic disease risk: a hybrid implementation-effectiveness study. Front Public Health. 2025 Jun 5;13:1564567. doi: 10.3389/fpubh.2025.1564567. eCollection 2025.

  PMID: 40538692 DERIVED

Related Links

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

Study Officials

• Carmen Samuel-Hodge, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Jennifer Leeman, DrPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Effectiveness-implementation hybrid Type 3 study design

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 5, 2021
• Study Start: October 26, 2021
• Primary Completion: September 29, 2023
• Study Completion: February 1, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 9 to 36 months following publication
• 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.

Locations

US (1)