A Personalized Health Behavior System

Not Applicable

Completed

• Conditions: Aging; Social Isolation; Physical Activity
• Interventions: Behavioral: Intervention Condition; Behavioral: Control Condition

• Registration Number: NCT03538158
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-25
• Study Start: 2018-11-26
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Results First Submitted: 2022-08-08
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-14
• Last Update Submitted: 2022-09-14
• Results First Posted: 2022-10-12
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention condition - Fittle Senior	Intervention Condition	Participants will have access to the Fittle Senior System which will provide guided exercises and social support.
Control condition - paper and pencil	Control Condition	Participants will have a written booklet with exercises that they may do it on their own.

Primary Outcome Measures

Name	Time	Method
VO2 Max	Baseline, 3 month follow-up and 6 month follow-up	Higher score of VO2 max indicates more oxygen consumption during incremental exercise.

Secondary Outcome Measures

Name	Time	Method
Timed Up and Go	Baseline, 3 month follow-up and 6 month follow-up	To start the TUG, you will sit in the chair with your arms resting comfortably on your lap or at your sides.; The test begins when the therapist says "Go" and starts the stopwatch. You would then be timed as you rise from the chair, walk three meters, turn around, return to the chair, and sit down.; The recorded time on the stopwatch is the TUG score. Measure to assess mobility. A faster time indicates a better functional performance.; An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.

Trial Locations

Locations (2)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States