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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 November 2012
• Main ID: NCT01472588
• Date of registration: 25/10/2011
• Primary sponsor: University of Arkansas
• Public title: Translating the Diabetes Prevention Program (DPP) Lifestyle Intervention to Rural African-American Communities (HEALTHY Ways)
• Scientific title: Translating the DPP Lifestyle Intervention to Rural African-American Communities
• Date of first enrolment: September 2007
• Target sample size: 279
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01472588
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Theresa E. Prewitt, DrPH
• Affiliation: University of Arkansas

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Overweight

Intervention(s)

Behavioral: DPP Lifestyle intervention--health professionals/(PHCs)

Behavioral: DPP lifestyle intervention-Community Health Coach (CHWs)

Other: Self Help

Primary Outcome(s)

Weight Loss [Time Frame: 16 months]

Secondary Outcome(s)

Physical Activity [Time Frame: 16 months]

Secondary ID(s)

5P20MD002329

UAMS IRB#: 99099

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center on Minority Health and Health Disparities (NCMHD)