Med-South Lifestyle Study: Phase 1

NCT04421703 | Completed

• 1 other identifier: 19-2079
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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 6

• 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 6

Secondary Outcomes (3)

• Mean Change Number of Fruit and Vegetable Servings Per Day

  Baseline, Month 6

• Mean Change in Minutes of Physical Activity Per Week

  Baseline, Month 6

• Mean Percent Change in Weight

  Baseline, Month 6

Study Arms (2)

Distance Collaborative

EXPERIMENTAL

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.

Behavioral: Med-South Lifestyle Program

Blended in-person/distance collaborative

EXPERIMENTAL

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.

Behavioral: Med-South Lifestyle Program

Interventions

Med-South Lifestyle Program BEHAVIORAL

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.

Blended in-person/distance collaborative; Distance Collaborative

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
• 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 (3)

Rural Health Group

Norlina, North Carolina, 27563, United States

Location

Granville-Vance Public Health

Oxford, North Carolina, 27565, United States

Location

Person Family Medical Center

Roxboro, North Carolina, 27573, United States

Location

Related Publications (7)

• 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

Related Links

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

Study Officials

• Carmen Samuel-Hodge, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

• Jennifer Leeman, DrPH

  UNC 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

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: June 9, 2020
• Study Start: December 1, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: November 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)