Translation of Obesity and Cognitive Program by Lay Health Educators (Coaches)
Primary Purpose
Overweight, Memory Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lifestyle counseling
Cognitive Training
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring behavioral weight control, lifestyle intervention, memory training, cognitive training, community-based
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lifestyle counseling
Cognitive Training
Arm Description
Diabetes Prevention Program Lifestyle Balance Intervention delivered by lay health educator
Adaptation of SeniorWise Memory Training program for delivery by lay health educator, matched in duration and contact to the other study arm
Outcomes
Primary Outcome Measures
weight loss
weight change from baseline in kg and percent weight loss [1-(12-month weight/baseline weight)
Secondary Outcome Measures
cognitive function
change in memory (immediate and delayed) and attention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01377506
Brief Title
Translation of Obesity and Cognitive Program by Lay Health Educators
Acronym
Coaches
Official Title
Translation of Obesity and Cognitive Research in a Rural State Via Senior Centers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Memory Disorder
Keywords
behavioral weight control, lifestyle intervention, memory training, cognitive training, community-based
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Diabetes Prevention Program Lifestyle Balance Intervention delivered by lay health educator
Arm Title
Cognitive Training
Arm Type
Active Comparator
Arm Description
Adaptation of SeniorWise Memory Training program for delivery by lay health educator, matched in duration and contact to the other study arm
Intervention Type
Behavioral
Intervention Name(s)
lifestyle counseling
Other Intervention Name(s)
DPP Lifestyle Balance Program
Intervention Description
21 session group-based behavioral weight management program delivered in senior center over 12 months by lay health educators
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
21 session group-based cognitive training program delivered in senior center over 12 months by lay health educators
Primary Outcome Measure Information:
Title
weight loss
Description
weight change from baseline in kg and percent weight loss [1-(12-month weight/baseline weight)
Time Frame
4 and 12 month
Secondary Outcome Measure Information:
Title
cognitive function
Description
change in memory (immediate and delayed) and attention
Time Frame
4 and 12 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delia S West, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21961465
Citation
West DS, Bursac Z, Cornell CE, Felix HC, Fausett JK, Krukowski RA, Lensing S, Love SJ, Prewitt TE, Beck C. Lay health educators translate a weight-loss intervention in senior centers: a randomized controlled trial. Am J Prev Med. 2011 Oct;41(4):385-91. doi: 10.1016/j.amepre.2011.06.041.
Results Reference
derived
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Translation of Obesity and Cognitive Program by Lay Health Educators
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