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

NCT ID: NCT01472588

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 277 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2014-01-31

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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Community Health Coach

DPP behavioral lifestyle intervention delivered by Community Health Coach (CHWs)

Group Type: EXPERIMENTAL

DPP lifestyle intervention-Community Health Coach (CHWs)

Intervention Type: 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.

Public Health Coach

DPP behavioral lifestyle intervention delivered by health professionals (PHCs)

Group Type: EXPERIMENTAL

DPP Lifestyle intervention--health professionals/(PHCs)

Intervention Type: 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.

Self Help

Booklet, Aim for a Healthy Weight (DHHS, NIH-NHLBI) provided.

Group Type: OTHER

Self Help

Intervention Type: OTHER

Public education/information booklet on weight management.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Self Help

Public education/information booklet on weight management.

Intervention Type: OTHER

Other Intervention Names

DPP Lifestyle Balance Program; DPP Lifestyle Balance Program; Aim for a Healthy Weight (DHHS, NIH-NHLBI); --publically available education material.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa E. Prewitt, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

5P20MD002329

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UAMS IRB#: 99099

Identifier Type: -

Identifier Source: org_study_id