A Personalized Health Behavior System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Social Isolation, Aging, Physical Activity

Intervention / Treatment
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* Behavioral: Intervention Condition
* Behavioral: Control Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention condition - Fittle Senior<br>Participants will have access to the Fittle Senior System which will provide guided exercises and social support. | Behavioral: Intervention Condition<br>* Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.<br>|
| Placebo Comparator: Control condition - paper and pencil<br>Participants will have a written booklet with exercises that they may do it on their own. | Behavioral: Control Condition<br>* Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 Max | Higher score of VO2 max indicates more oxygen consumption during incremental exercise. | Baseline, 3 month follow-up and 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go | 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. | Baseline, 3 month follow-up and 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Physical well-being, Quality of life