Translation of Obesity and Cognitive Program by Lay Health Educators (Coaches)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01377506
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 25, 2012
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment
Overweight Memory Disorder Behavioral: lifestyle counseling Behavioral: Cognitive Training

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Translation of Obesity and Cognitive Research in a Rural State Via Senior Centers
Study Start Date : September 2007
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lifestyle counseling
Diabetes Prevention Program Lifestyle Balance Intervention delivered by lay health educator
Behavioral: lifestyle counseling
21 session group-based behavioral weight management program delivered in senior center over 12 months by lay health educators
Other Name: DPP Lifestyle Balance Program
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
Behavioral: Cognitive Training
21 session group-based cognitive training program delivered in senior center over 12 months by lay health educators

Primary Outcome Measures :
  1. weight loss [ Time Frame: 4 and 12 month ]
    weight change from baseline in kg and percent weight loss [1-(12-month weight/baseline weight)

Secondary Outcome Measures :
  1. cognitive function [ Time Frame: 4 and 12 month ]
    change in memory (immediate and delayed) and attention

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01377506

Sponsors and Collaborators
University of Arkansas
Principal Investigator: Delia S West, PhD University of Arkansas

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Arkansas Identifier: NCT01377506     History of Changes
Other Study ID Numbers: 104877
R18DP001145 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012

Keywords provided by University of Arkansas:
behavioral weight control
lifestyle intervention
memory training
cognitive training

Additional relevant MeSH terms:
Memory Disorders
Body Weight
Signs and Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases