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Clinical Trials/NCT03538158
NCT03538158
Completed
N/A

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

Weill Medical College of Cornell University2 sites in 1 country181 target enrollmentNovember 26, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Social Isolation
Sponsor
Weill Medical College of Cornell University
Enrollment
181
Locations
2
Primary Endpoint
VO2 Max
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
October 26, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

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

Outcomes

Primary Outcomes

VO2 Max

Time Frame: Baseline, 3 month follow-up and 6 month follow-up

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

Secondary Outcomes

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

Study Sites (2)

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