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

Overweight Clinical Trial

Official title:

Translating the DPP Lifestyle Intervention to Rural African-American Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472588
• Other study ID #: UAMS IRB#: 99099
• Secondary ID: 5P20MD002329
• Status: Completed
• Phase: Phase 2
• Start date: September 2007
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

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.
• 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:
• Self Help
Public education/information booklet on weight management.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	change in weight (% loss) from baseline to 16 months	16 months
Secondary	Physical Activity	change in number of minutes of physical activity, baseline to 16 months.	16 months