Translating the Diabetes Prevention Program (DPP) Lifestyle Intervention to Rural African-American Communities (HEALTHY Ways)
| Tracking Information | |||||
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| First Received Date ICMJE | October 25, 2011 | ||||
| Last Updated Date | November 19, 2012 | ||||
| Start Date ICMJE | September 2007 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Weight Loss [ Time Frame: 16 months ] [ Designated as safety issue: No ] change in weight (% loss) from baseline to 16 months |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01472588 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Physical Activity [ Time Frame: 16 months ] [ Designated as safety issue: No ] change in number of minutes of physical activity, baseline to 16 months. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Translating the Diabetes Prevention Program (DPP) Lifestyle Intervention to Rural African-American Communities (HEALTHY Ways) | ||||
| Official Title ICMJE | Translating the DPP Lifestyle Intervention to Rural African-American Communities | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Overweight | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 279 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01472588 | ||||
| Other Study ID Numbers ICMJE | UAMS IRB#: 99099, 5P20MD002329 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | University of Arkansas | ||||
| Study Sponsor ICMJE | University of Arkansas | ||||
| Collaborators ICMJE | National Center on Minority Health and Health Disparities (NCMHD) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Arkansas | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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