跳至主要内容
临床试验/NCT01377506
NCT01377506已完成不适用

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

University of Arkansas0 个研究点目标入组 16 人开始时间: 2007年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
主要终点
weight loss

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Lifestyle counseling

Experimental

Diabetes Prevention Program Lifestyle Balance Intervention delivered by lay health educator

干预措施: lifestyle counseling (Behavioral)

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

干预措施: Cognitive Training (Behavioral)

结局指标

主要结局

weight loss

时间窗: 4 and 12 month

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

次要结局

  • cognitive function(4 and 12 month)

研究者

申办方类型
Other
责任方
Sponsor

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