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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
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 17, 2011
    Last Updated
    June 21, 2012
    Sponsor
    University of Arkansas
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    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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