Med-South Lifestyle Program Implementation Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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:
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| 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:
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Outcome Measures
Primary Outcome Measures
- Percentage of Eligible Patients Participating [Month 10]
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.
- Percentage of Med-South Lifestyle Program Delivered as Intended [Month 10]
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.
Secondary Outcome Measures
- Mean Change in Number of Fruit and Vegetable Servings Per Day [Month 0, Month 10]
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.
- Mean Change in Minutes of Physical Activity Per Week [Month 0, Month 10]
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.
- Mean Percent Change in Weight [Month 0, Month 10]
Mean weight change (in kg) from baseline to follow-up expressed as a percentage of baseline weight
- Mean Change in Systolic Blood Pressure at end of 4-Month Med-South Program [Month 0, Month 4]
Mean difference in systolic blood pressure measured at session 1 and at the end of the Med-south Program (session 4).
- Mean Change in Systolic Blood Pressure at end of 6-Month Maintenance Phase [Month 4, Month 10]
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).
- Mean Change in Diastolic Blood Pressure at end of 4-Month Med-South Program [Month 0, Month 4]
Mean difference in diastolic blood pressure measured at session 1 and at the end of the Med-South Program (session 4).
- Mean Change in Diastolic Blood Pressure at end of 6-Month Maintenance Phase [Month 4, Month 10]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female
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English speaking (Spanish-speaking only in selected sites with bilingual staff)
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Ages 18-80
Exclusion Criteria:
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Malignancy
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Advanced kidney disease (estimated creatinine clearance < 30 mL/min)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UNC Chapel Hill | Chapel Hill | North Carolina | United States | 27514 |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
- Centers for Disease Control and Prevention
Investigators
- Principal Investigator: Jennifer Leeman, DrPH, UNC Chapel Hill
- Principal Investigator: CARMEN SAMUEL-HODGE, PhD, UNC at Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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. Review.
- 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.
- 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.
- 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.
- 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.
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