A Personalized Health Behavior System

Aging Clinical Trial

— FITTLESenior  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538158
• Other study ID #: 1806019352
• Secondary ID: R01AG053163
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: October 26, 2021

Study information

• Verified date: September 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Physical Activity
• Social Isolation

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Weill Cornell Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Florida Institute for Human and Machine Cognition, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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