ClinicalTrials.gg
CompletedNCT01472588Updated Oct 23, 2023

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

A Phase 2 interventional study of DPP lifestyle intervention-Community Health Coach (CHWs) and DPP Lifestyle intervention--health professionals/(PHCs) in Overweight, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by University of Arkansas · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
277
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight

Browse trials for

03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's enrollment of 277 is above the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Arkansas is the lead sponsor of 398 studies on the registry; 37 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
277 participants (actual)

Study arms

  • Experimental
    Community Health Coach

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

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

  • Experimental
    Public Health Coach

    DPP behavioral lifestyle intervention delivered by health professionals (PHCs)

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

  • Other
    Self Help

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

    Other: Self Help

Interventions

  • BehavioralDPP 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.

    Also known as: DPP Lifestyle Balance Program

  • BehavioralDPP 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.

    Also known as: DPP Lifestyle Balance Program

  • OtherSelf Help

    Public education/information booklet on weight management.

    Also known as: Aim for a Healthy Weight (DHHS, NIH-NHLBI), --publically available education material.

06

What researchers measure

Primary outcomes

  1. Weight Loss

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

    Time frame: 16 months

Secondary outcomes

  1. Physical Activity

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

    Time frame: 16 months

07

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01472588
Responsible party
Sponsor
First posted
Nov 16, 2011
Start date
Sep 2007
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Oct 23, 2023

Study contacts

Theresa E. Prewitt, DrPH
principal investigator · University of Arkansas
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion