OverweightPhase 2NCT01472588
Translating the Diabetes Prevention Program (DPP) Lifestyle Intervention to Rural African-American Communities (HEALTHY Ways)
A Phase 2 study testing DPP lifestyle intervention-Community Health Coach (CHWs), DPP Lifestyle intervention--health professionals/(PHCs) and Self Help in people with Overweight, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- DPP lifestyle intervention-Community Health Coach (CHWs), DPP Lifestyle intervention--health professionals/(PHCs) and Self Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Translating the DPP Lifestyle Intervention to Rural African-American Communities
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
- Being tested
- DPP lifestyle intervention-Community Health Coach (CHWs), DPP Lifestyle intervention--health professionals/(PHCs), Self Help
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPP lifestyle intervention-Community Health Coach (CHWs)Behavioural
Also called DPP Lifestyle Balance Program
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)Behavioural
Also called DPP Lifestyle Balance Program
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 HelpOther
Also called Aim for a Healthy Weight (DHHS, NIH-NHLBI), --publically available education material.
Public education/information booklet on weight management.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Coach | Experimental | DPP behavioral lifestyle intervention delivered by Community Health Coach (CHWs) Receives: Behavioral: DPP lifestyle intervention-Community Health Coach (CHWs) |
| Public Health Coach | Experimental | DPP behavioral lifestyle intervention delivered by health professionals (PHCs) Receives: Behavioral: DPP Lifestyle intervention--health professionals/(PHCs) |
| Self Help | Other | Booklet, Aim for a Healthy Weight (DHHS, NIH-NHLBI) provided. Receives: Other: Self Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
change in weight (% loss) from baseline to 16 months
Measured: 16 months
Secondary outcomes (1)
Physical Activity
change in number of minutes of physical activity, baseline to 16 months.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startSep 2007
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Theresa E. Prewitt, DrPH, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472588
- Sponsor's protocol ID
- UAMS IRB#: 99099
- Other IDs
- 5P20MD002329
- Status last verified
- Sep 2014
- First submitted
- 25 Oct 2011
- Last updated
- 23 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating the DPP Lifestyle Intervention to Rural African-American Communities
- ClinicalTrials.gov ID
- NCT01472588
- Acronym / sponsor ID
- UAMS IRB#: 99099
- Conditions
- Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Sep 2007
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community Health Coach | Experimental | Behavioral: DPP lifestyle intervention-Community Health Coach (CHWs)DPP behavioral lifestyle intervention delivered by Community Health Coach (CHWs) |
| Public Health Coach | Experimental | Behavioral: DPP Lifestyle intervention--health professionals/(PHCs)DPP behavioral lifestyle intervention delivered by health professionals (PHCs) |
| Self Help | Other | Other: Self HelpBooklet, Aim for a Healthy Weight (DHHS, NIH-NHLBI) provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPP lifestyle intervention-Community Health Coach (CHWs)Also: DPP Lifestyle Balance ProgramLifestyle 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. | Behavioural | Community Health Coach |
| DPP Lifestyle intervention--health professionals/(PHCs)Also: DPP Lifestyle Balance ProgramLifestyle 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. | Behavioural | Public Health Coach |
| Self HelpAlso: Aim for a Healthy Weight (DHHS, NIH-NHLBI), --publically available education material.Public education/information booklet on weight management. | Other | Self Help |
Primary outcome
Weight Loss
Time frame: 16 months
change in weight (% loss) from baseline to 16 months
1 secondary outcome
Physical Activity
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa E. Prewitt, DrPH principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DPP lifestyle intervention-Community Health Coach (CHWs), DPP Lifestyle intervention--health professionals/(PHCs) and Self Help in people with Overweight, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.