A Personalized Health Behavior System (FITTLESenior)

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Aging; Social Isolation
• Intervention / Treatment: Behavioral: Intervention Condition; Behavioral: Control Condition

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Health and Well-being as Measured by Modified SF-36	Higher score means better functional health and well-being. Range (0-1400)	Baseline, 3 month follow-up and 6 month follow-up
Change in Loneliness as Measured by Loneliness Scale	Higher score indicates a greater degree of loneliness. Range (0-80)	Baseline, 3 month follow-up and 6 month follow-up
Change in Social Isolation as Measured by Friendship Scale	Measures the level of social isolation. Lower score indicates less social isolation. Range (0-24)	Baseline, 3 month follow-up and 6 month follow-up
Change in Social Support as Measured by Interpersonal Support Evaluation List - ISEL	Measures the level of functional social support. Higher scores indicates better and more social support	Baseline, 3 month follow-up and 6 month follow-up

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA); Florida Institute for Human and Machine Cognition
• Investigators: Principal Investigator: Sara J. Czaja, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Older adults; Physical well-being
• Other Study ID Numbers: 1806019352; R01AG053163 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared with investigators upon request. This data will include sociodemographic data and outcome measures including SF-36, Loneliness Scale, Friendship Scale and Interpersonal Support Evaluation List (ISEL) scores. IPD will be free from any Personal Health Identifiers.
• IPD Sharing Time Frame: Data will become available following the publication of the primary outcomes paper and will be available at request for 5 years.
• IPD Sharing Access Criteria: Data will be available to investigators at request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No