Translating the Diabetes Prevention Program (DPP) Lifestyle Intervention to Rural African-American Communities (HEALTHY Ways)

Study Overview
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Brief Summary
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Obesity is a significant and growing problem in the US that negatively impacts health and well-being of racial and ethnic minorities, people of low socioeconomic status, and persons living in rural communities and in the South. Obesity is a major concern in Arkansas, where the obesity rate for adults is higher than the rate for other adults in the nation. However effective weight loss programs are not typically available in these communities. Research has shown that the Diabetes Prevention Program (DPP) lifestyle intervention is effective in promoting weight loss in high risk individuals through changes in diet and physical activity that significantly reduce the chances of type 2 diabetes. Effective methods are desperately needed to translate the DPP to community settings, where obesity is a compelling public health burden. A major step in translating the DPP is to examine the efficacy of health professionals and community health workers (CHWs) in delivering the program in real-world settings. This is an important issue from the perspective of how evidence-based weight loss interventions can be provided to underserved, and resource constrained communities that typically may not have access to trained professionals for program delivery. The current project is a 5 year randomized controlled trial that examines DPP delivery and weight outcomes for individuals randomly assigned to either: (1) the DPP intervention delivered by CHWs or (2) the DPP intervention delivered by health professionals or (3) the Self Help condition. The study population consists of overweight adults (body mass index (BMI) > 25) who reside in communities with a high proportion of African Americans. Primary outcome is change in body weight at 16 months. Cost effectiveness and lifestyle behaviors are also evaluated.

Official Title
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Translating the DPP Lifestyle Intervention to Rural African-American Communities

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: DPP lifestyle intervention-Community Health Coach (CHWs)
* Behavioral: DPP Lifestyle intervention--health professionals/(PHCs)
* Other: Self Help


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-institutionalized men and women aged 18 and older BMI [weight (kg)/ height (m2)] > 25 Able to walk for exercise Able to provide informed consent Willing to accept random assignment Exclusion Criteria: Currently pregnant or nursing, or pregnant within previous 6 months Recent heart attack or stroke (in past 6 months) Congestive heart failure (NYHA Class 3-4) History of bariatric surgery or weight loss in excess of 10% in past 6 months Current use of weight loss medications Another member of household enrolled in study Presence of significant impairment that might interfere with participation, such as underlying disease likely to limit lifespan, infectious disease (e.g., HIV, tuberculosis), substantial cognitive impairment, renal dialysis, diagnosis of schizophrenia, psychosis or substance abuse, or other condition that might compromise participation or for which weight loss is not recommended Plans to move from the area within the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community Health Coach<br>DPP behavioral lifestyle intervention delivered by Community Health Coach (CHWs) | Behavioral: DPP lifestyle intervention-Community Health Coach (CHWs)<br>* Lifestyle counseling. During a 16 month period, the behavioral weight loss program (n=24 sessions of the DPP lifestyle intervention) is delivered by CHWs in group format in community settings.<br>* Other names: DPP Lifestyle Balance Program;|
| Experimental: Public Health Coach<br>DPP behavioral lifestyle intervention delivered by health professionals (PHCs) | Behavioral: DPP Lifestyle intervention--health professionals/(PHCs)<br>* Lifestyle counseling. During a 16 month period, the behavioral weight loss program (n=24 sessions of the DPP lifestyle intervention) is delivered by PHCs in group format in community settings.<br>* Other names: DPP Lifestyle Balance Program;|
| Other: Self Help<br>Booklet, Aim for a Healthy Weight (DHHS, NIH-NHLBI) provided. | Other: Self Help<br>* Public education/information booklet on weight management.<br>* Other names: --publically available education material.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | change in weight (% loss) from baseline to 16 months | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | change in number of minutes of physical activity, baseline to 16 months. | 16 months |