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临床试验/NCT03538158
NCT03538158已完成不适用

A Personalized Health Behavior System to Promote Well-Being in Older Adults (FITTLE)

Weill Medical College of Cornell University3 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2018年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
181
试验地点
3
主要终点
VO2 Max

研究概览

简要总结

The objectives of this study are to examine the usability and efficacy, for diverse older adults, of a new tablet-based dynamic system: the Fittle Senior System (FSS) that will provide: (1) personalized behavior-change programs for improved diet and increased physical activity and (2) online social interaction and support from small teams pursuing similar goals.

The proposed study involves a two group randomized trial where participants will be randomized to the Fittle Senior System or to a paper-based psycho-educational control condition following a baseline assessment. The duration of the intervention phase will involve an active 12-week intervention phase followed by a 12-week maintenance phase. We will recruit and randomize 180 community dwelling adults aged 65+ years, who live alone and are at risk for social isolation. Participants will be assessed at baseline, 3 months post active intervention and 3 months post maintenance (6 months following active intervention) on measures of health and health behaviors, and indices of social support.

详细描述

The proposed study will evaluate a new tablet-based dynamic system: the Fittle Senior System (FSS) that will provide: (1) personalized, goal-directed behavior-change programs for improved diet and increased physical activity and (2) online social interaction and support from small teams pursuing similar goals. The system builds on two technology-based systems developed by the investigative team: (1) the computer-based PRISM system (Czaja et al., 2015), designed for older populations to support social connectivity and well-being, and (2) the Fittle mobile platform (PARC) designed to support positive health behavior change through integrated online social support and personalized coaching based on artificial intelligence (AI). The Fittle program is based on Self-efficacy and Social Cognitive Theory (Bandura, 1998, 2001), Goal Setting (Locke & Latham, 2002) and the Theory of Planned Behavior (Ajzen, 1991). Fittle provides support for individuals and teams to progress through lifestyle challenges (e.g., poor eating habits, sedentary behavior), helping individuals master one health improving habit after another in a way that builds on previous achievements. Individuals choose from a variety of challenges to accomplish goals via an intelligent coaching agent and personalized, engaging user experiences. The objective is to maintain and reinforce perceived self-efficacy with daily goals that are perceived as being achievable, and to improve motivation and ability with goals that are perceived as not too easy. The program provides encouragement and social support through a team component. Thus, Fittle is designed to reinforce and build self-efficacy and positive attitudes.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 60 years old
  • Speak English
  • Able to read at the 6th grade
  • Plans to remain in the area for the study duration
  • Pass TICS (Telephone Screen for Cognitive Status)

排除标准

  • Cognitively impaired
  • Visual or hearing impairment
  • Actively engaged in structured physical exercise regularly
  • Health conditions/illness that would affect participation

结局指标

主要结局

VO2 Max

时间窗: Baseline, 3 month follow-up and 6 month follow-up

Higher score of VO2 max indicates more oxygen consumption during incremental exercise.

次要结局

  • Timed Up and Go(Baseline, 3 month follow-up and 6 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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