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Completed

NCT Number: NCT01377506

Translation of Obesity and Cognitive Program by Lay Health Educators

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

21 session group-based behavioral weight management program delivered in senior center over 12 months by lay health educators

Other names: DPP Lifestyle Balance Program

Cognitive training

Behavioral

21 session group-based cognitive training program delivered in senior center over 12 months by lay health educators

Primary outcomes

  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 outcomes

  1. cognitive function

    Time frame: 4 and 12 month

    change in memory (immediate and delayed) and attention

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

Translation of Obesity and Cognitive Research in a Rural State Via Senior Centers

Acronym: Coaches

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jun 21, 2011
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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