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

Phase 2

Completed

• Conditions: Overweight
• Interventions: Behavioral: DPP lifestyle intervention-Community Health Coach (CHWs); Other: Self Help; Behavioral: DPP Lifestyle intervention--health professionals/(PHCs)

• Registration Number: NCT01472588
• Lead Sponsor: University of Arkansas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-16
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-09
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

Inclusion Criteria

1. Non-institutionalized men and women aged 18 and older
2. BMI [weight (kg)/ height (m2)] > 25
3. Able to walk for exercise
4. Able to provide informed consent
5. Willing to accept random assignment

Exclusion Criteria

1. Currently pregnant or nursing, or pregnant within previous 6 months
2. Recent heart attack or stroke (in past 6 months)
3. Congestive heart failure (NYHA Class 3-4)
4. History of bariatric surgery or weight loss in excess of 10% in past 6 months
5. Current use of weight loss medications
6. Another member of household enrolled in study
7. 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
8. Plans to move from the area within the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Health Coach	DPP lifestyle intervention-Community Health Coach (CHWs)	DPP behavioral lifestyle intervention delivered by Community Health Coach (CHWs)
Self Help	Self Help	Booklet, Aim for a Healthy Weight (DHHS, NIH-NHLBI) provided.
Public Health Coach	DPP Lifestyle intervention--health professionals/(PHCs)	DPP behavioral lifestyle intervention delivered by health professionals (PHCs)

Primary Outcome Measures

Name	Time	Method
Weight Loss	16 months	change in weight (% loss) from baseline to 16 months

Secondary Outcome Measures

Name	Time	Method
Physical Activity	16 months	change in number of minutes of physical activity, baseline to 16 months.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States