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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01377506
First received: June 17, 2011
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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 Intervention
Overweight
Memory Disorder
Behavioral: lifestyle counseling
Behavioral: Cognitive Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Translation of Obesity and Cognitive Research in a Rural State Via Senior Centers

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • weight loss [ Time Frame: 4 and 12 month ] [ Designated as safety issue: No ]
    weight change from baseline in kg and percent weight loss [1-(12-month weight/baseline weight)


Secondary Outcome Measures:
  • cognitive function [ Time Frame: 4 and 12 month ] [ Designated as safety issue: No ]
    change in memory (immediate and delayed) and attention


Enrollment: 16
Study Start Date: September 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377506

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

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01377506     History of Changes
Other Study ID Numbers: 104877, R18 DP001145
Study First Received: June 17, 2011
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board
Sponsor: CDC

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

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

ClinicalTrials.gov processed this record on August 28, 2014