A Personalized Health Behavior System

Overview

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.

Full Title of Study: “A Personalized Health Behavior System to Promote Well-Being in Older Adults (FITTLE)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 1, 2020

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.

Interventions

  • Behavioral: Intervention Condition
    • Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.
  • Behavioral: Control Condition
    • Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.

Arms, Groups and Cohorts

  • Experimental: Intervention condition – Fittle Senior
    • Participants will have access to the Fittle Senior System which will provide guided exercises and social support.
  • Placebo Comparator: Control condition – paper and pencil
    • Participants will have a written booklet with exercises that they may do it on their own.

Clinical Trial Outcome Measures

Primary Measures

  • Change in 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. Range (10+)

Secondary Measures

  • Change in Timed Up and Go
    • Time Frame: Baseline, 3 month follow-up and 6 month follow-up
    • Measure of fall risk. A faster time indicates a better functional performance. Range (1+)

Participating in This Clinical Trial

Inclusion Criteria

  • At least 65 years old
  • Self-identified as White, Black, or Hispanic
  • Speak English or Spanish
  • Able to read at the 6th grade
  • Living alone
  • Planning to stay in the study geographical area for the duration of the study

Exclusion Criteria

  • Cognitively impaired
  • Visual impairment
  • Actively engaged in structure physical exercise regularly
  • Lack of doctor's clearance to participate in the study

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Weill Medical College of Cornell University
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sara J. Czaja, PhD, Principal Investigator, Weill Cornell Medicine
  • Overall Contact(s)
    • Chelsie O Burchett, MA, 6469627140, cob2014@med.cornell.edu

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