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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01472588
First received: October 25, 2011
Last updated: January 15, 2014
Last verified: January 2014

October 25, 2011
January 15, 2014
September 2007
October 2013   (final data collection date for primary outcome measure)
Weight Loss [ Time Frame: 16 months ] [ Designated as safety issue: No ]
change in weight (% loss) from baseline to 16 months
Same as current
Complete list of historical versions of study NCT01472588 on ClinicalTrials.gov Archive Site
Physical Activity [ Time Frame: 16 months ] [ Designated as safety issue: No ]
change in number of minutes of physical activity, baseline to 16 months.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Overweight
  • Behavioral: DPP 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.
    Other Name: DPP Lifestyle Balance Program
  • Behavioral: DPP 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.
    Other Name: DPP Lifestyle Balance Program
  • Other: Self Help
    Public education/information booklet on weight management.
    Other Names:
    • Aim for a Healthy Weight (DHHS, NIH-NHLBI)
    • --publically available education material.
  • Experimental: Community Health Coach
    DPP behavioral lifestyle intervention delivered by Community Health Coach (CHWs)
    Intervention: Behavioral: DPP lifestyle intervention-Community Health Coach (CHWs)
  • Experimental: Public Health Coach
    DPP behavioral lifestyle intervention delivered by health professionals (PHCs)
    Intervention: Behavioral: DPP Lifestyle intervention--health professionals/(PHCs)
  • Self Help
    Booklet, Aim for a Healthy Weight (DHHS, NIH-NHLBI) provided.
    Intervention: Other: Self Help
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
277
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01472588
UAMS IRB#: 99099, 5P20MD002329
Not Provided
University of Arkansas
University of Arkansas
National Center on Minority Health and Health Disparities (NCMHD)
Principal Investigator: Theresa E. Prewitt, DrPH University of Arkansas
University of Arkansas
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP