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
2 other identifiers
interventional
277
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 25, 2011
CompletedFirst Posted
Study publicly available on registry
November 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedOctober 23, 2023
September 1, 2014
6.3 years
October 25, 2011
October 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Weight Loss
change in weight (% loss) from baseline to 16 months
16 months
Secondary Outcomes (1)
Physical Activity
16 months
Study Arms (3)
Community Health Coach
EXPERIMENTALDPP behavioral lifestyle intervention delivered by Community Health Coach (CHWs)
Public Health Coach
EXPERIMENTALDPP behavioral lifestyle intervention delivered by health professionals (PHCs)
Self Help
OTHERBooklet, Aim for a Healthy Weight (DHHS, NIH-NHLBI) provided.
Interventions
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.
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.
Public education/information booklet on weight management.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa E. Prewitt, DrPH
University of Arkansas
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2011
First Posted
November 16, 2011
Study Start
September 1, 2007
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
October 23, 2023
Record last verified: 2014-09