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NCT01472588 · ClinicalTrials.gov registry record · Phase 2
Translating the Diabetes Prevention Program (DPP) Lifestyle Intervention to Rural African-American Communities (HEALTHY Ways)
A Phase 2 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 2
- Development phase
- 277
- Enrollment target
NCT01472588 is a Phase 2 study that has completed, run by University of Arkansas. The registered enrollment target is 277 participants.
The verdict
NCT01472588, a Phase 2 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 277 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL DPP lifestyle intervention-Community Health Coach (CHWs)
- BEHAVIORAL DPP Lifestyle intervention--health professionals/(PHCs)
- OTHER Self Help
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2007-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01472588
The ClinicalTrials.gov registry entry for NCT01472588 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 277 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which DPP lifestyle intervention-Community Health Coach (CHWs) is the first listed.
NCT01472588 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01472588 about?
NCT01472588 is a clinical study titled "Translating the Diabetes Prevention Program (DPP) Lifestyle Intervention to Rural African-American Communities (HEALTHY Ways)". 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 adult...
What is the current status of trial NCT01472588?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 277 participants. The study started on 2007-09. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01472588?
The interventions under investigation include: DPP lifestyle intervention-Community Health Coach (CHWs) (BEHAVIORAL), DPP Lifestyle intervention--health professionals/(PHCs) (BEHAVIORAL), Self Help (OTHER).
Who is sponsoring clinical trial NCT01472588?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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