Clinical Trials Directory

Trials / Completed

CompletedNCT01472588

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

Translating the DPP Lifestyle Intervention to Rural African-American Communities

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
277 (actual)
Sponsor
University of Arkansas · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDPP lifestyle intervention-Community Health Coach (CHWs)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.
BEHAVIORALDPP Lifestyle intervention--health professionals/(PHCs)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.
OTHERSelf HelpPublic education/information booklet on weight management.

Timeline

Start date
2007-09-01
Primary completion
2014-01-01
Completion
2014-01-01
First posted
2011-11-16
Last updated
2023-10-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01472588. Inclusion in this directory is not an endorsement.