- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377506
Translation of Obesity and Cognitive Program by Lay Health Educators (Coaches)
June 21, 2012 updated by: University of Arkansas
Translation of Obesity and Cognitive Research in a Rural State Via Senior Centers
Obesity is a major public health problem among older adults, with 31% of non-institutionalized older persons (60 years+) in the US obese and projections indicating that this will rise to 40% by 2010.
A second public health challenge on the horizon for the aging US population is the increasing number of individuals experiencing cognitive decline, dementia or Alzheimer 's disease.
Recent clinical trials have demonstrated efficacy in reducing risks associated with both of these significant and increasingly pervasive health problems, which are more common among rural, low income and ethnic minority populations.
The Diabetes Prevention Program (DPP) Lifestyle Intervention produced sustained weight losses in a large, diverse population of high-risk individuals and dramatically reduced rates of type 2 diabetes onset, particularly among older adults.
SeniorWISE produced improvements in memory in community dwelling older persons.
Transferring these exciting technologies to community settings where they can benefit older adults is a pressing public health need.
Therefore, the current project seeks to transfer these two evidence-based interventions to older adults in a rural state using senior centers as the venue for dissemination and lay health educators to deliver the interventions.
Senior centers are a particularly attractive context for translation of evidence-based health promotion technologies in predominantly rural states like Arkansas because they have a well-established infrastructure in communities and share a common goal of promoting healthy aging and reducing health care costs.
The 3-year randomized, controlled trial will evaluate translation of the interventions by randomizing senior centers (N=16) across Arkansas to implement either (1) the DPP Lifestyle Weight Loss Program or (2) the SeniorWISE Cognitive Training Program.
Older (age > 60) adults (N=288) nested within senior centers will receive the programs delivered in a group format by a trained lay health educator.
Primary outcomes are changes in body weight and cognitive functioning at 12 months.
The multi-level evaluation plan will characterize reach, effectiveness, adoption, implementation and maintenance of the interventions, with a cost effectiveness component.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria for senior centers (unit of randomization):
- located in the state of Arkansas
- agree to be randomized
- able to identify two or three volunteers or staff members willing to be trained (including IRB certification) and deliver the programs within the senior center over the course of a year
- have adequate space for group meetings and for private data collection visits
- agreement that it would be likely that they could identify 18 interested and eligible (obese and not cognitively impaired) senior adults willing to attend the program over the course of 12 months
Exclusion Criteria:
- inability to identify and secure lay health educator from within their community
- concerns of inability to recruit the requisite 18 senior adult participants who met minimal inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lifestyle counseling
Diabetes Prevention Program Lifestyle Balance Intervention delivered by lay health educator
|
21 session group-based behavioral weight management program delivered in senior center over 12 months by lay health educators
Other Names:
|
|
Active Comparator: Cognitive Training
Adaptation of SeniorWise Memory Training program for delivery by lay health educator, matched in duration and contact to the other study arm
|
21 session group-based cognitive training program delivered in senior center over 12 months by lay health educators
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight loss
Time Frame: 4 and 12 month
|
weight change from baseline in kg and percent weight loss [1-(12-month weight/baseline weight)
|
4 and 12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cognitive function
Time Frame: 4 and 12 month
|
change in memory (immediate and delayed) and attention
|
4 and 12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Delia S West, PhD, University of Arkansas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
June 17, 2011
First Submitted That Met QC Criteria
June 17, 2011
First Posted (Estimate)
June 21, 2011
Study Record Updates
Last Update Posted (Estimate)
June 25, 2012
Last Update Submitted That Met QC Criteria
June 21, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 104877
- R18DP001145 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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