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

Primary Purpose

Overweight

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DPP lifestyle intervention-Community Health Coach (CHWs)
DPP Lifestyle intervention--health professionals/(PHCs)
Self Help
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Community Health Coach

Public Health Coach

Self Help

Arm Description

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

DPP behavioral lifestyle intervention delivered by health professionals (PHCs)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2011
Last Updated
October 19, 2023
Sponsor
University of Arkansas
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01472588
Brief Title
Translating the Diabetes Prevention Program (DPP) Lifestyle Intervention to Rural African-American Communities (HEALTHY Ways)
Official Title
Translating the DPP Lifestyle Intervention to Rural African-American Communities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community Health Coach
Arm Type
Experimental
Arm Description
DPP behavioral lifestyle intervention delivered by Community Health Coach (CHWs)
Arm Title
Public Health Coach
Arm Type
Experimental
Arm Description
DPP behavioral lifestyle intervention delivered by health professionals (PHCs)
Arm Title
Self Help
Arm Type
Other
Arm Description
Booklet, Aim for a Healthy Weight (DHHS, NIH-NHLBI) provided.
Intervention Type
Behavioral
Intervention Name(s)
DPP lifestyle intervention-Community Health Coach (CHWs)
Other Intervention Name(s)
DPP Lifestyle Balance Program
Intervention Description
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
Intervention Name(s)
DPP Lifestyle intervention--health professionals/(PHCs)
Other Intervention Name(s)
DPP Lifestyle Balance Program
Intervention Description
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
Other
Intervention Name(s)
Self Help
Other Intervention Name(s)
Aim for a Healthy Weight (DHHS, NIH-NHLBI), --publically available education material.
Intervention Description
Public education/information booklet on weight management.
Primary Outcome Measure Information:
Title
Weight Loss
Description
change in weight (% loss) from baseline to 16 months
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Physical Activity
Description
change in number of minutes of physical activity, baseline to 16 months.
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa E. Prewitt, DrPH
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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

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