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Completed

NCT Number: NCT01472588

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 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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

DPP lifestyle intervention-Community Health Coach (CHWs)

Behavioral

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 names: DPP Lifestyle Balance Program

DPP Lifestyle intervention--health professionals/(PHCs)

Behavioral

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 names: DPP Lifestyle Balance Program

Self Help

Other

Public education/information booklet on weight management.

Other names: Aim for a Healthy Weight (DHHS, NIH-NHLBI), --publically available education material.

Primary outcomes

  1. Weight Loss

    Time frame: 16 months

    change in weight (% loss) from baseline to 16 months

Secondary outcomes

  1. Physical Activity

    Time frame: 16 months

    change in number of minutes of physical activity, baseline to 16 months.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Translating the DPP Lifestyle Intervention to Rural African-American Communities

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Nov 16, 2011
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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