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OpenTrials
Completed

NCT Number: NCT03538158

A Personalized Health Behavior System

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.

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Key information

Conditions

Social Isolation Aging Behavior Motor Activity Physical Activity Social Behavior

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Miller School of Medicine, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Condition

Behavioral

Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.

Control condition

Behavioral

Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.

Primary outcomes

  1. 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

  1. Timed Up and Go

    Time frame: 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.

Other outcomes

  1. Change in Functional Health and Well-being as Measured by Modified SF-36

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

    Higher score means better functional health and well-being. Range (0-1400)

  2. Change in Loneliness as Measured by Loneliness Scale

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

    Higher score indicates a greater degree of loneliness. Range (0-80)

  3. Change in Social Isolation as Measured by Friendship Scale

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

    Measures the level of social isolation. Lower score indicates less social isolation. Range (0-24)

  4. Change in Social Support as Measured by Interpersonal Support Evaluation List - ISEL

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

    Measures the level of functional social support. Higher scores indicates better and more social support

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Florida Institute for Human and Machine Cognition
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: FITTLESenior

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 25, 2018
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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