NCT01377506

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

3.8 years

First QC Date

June 17, 2011

Last Update Submit

June 21, 2012

Conditions

Keywords

behavioral weight controllifestyle interventionmemory trainingcognitive trainingcommunity-based

Outcome Measures

Primary Outcomes (1)

  • weight loss

    weight change from baseline in kg and percent weight loss \[1-(12-month weight/baseline weight)

    4 and 12 month

Secondary Outcomes (1)

  • cognitive function

    4 and 12 month

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Diabetes Prevention Program Lifestyle Balance Intervention delivered by lay health educator

Behavioral: lifestyle counseling

Cognitive Training

ACTIVE COMPARATOR

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

Interventions

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

Also known as: DPP Lifestyle Balance Program
Lifestyle counseling

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

Cognitive Training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • inability to identify and secure lay health educator from within their community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightMemory Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Delia S West, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2011

First Posted

June 21, 2011

Study Start

September 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

June 25, 2012

Record last verified: 2012-06