A Personalized Health Behavior System (FITTLESenior)

• ClinicalTrials.gov Identifier: NCT03538158
• Recruitment Status: Completed
• First Posted: May 25, 2018
• Last Update Posted: December 22, 2021
• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA); Florida Institute for Human and Machine Cognition
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Social Isolation; Aging; Physical Activity	Behavioral: Intervention Condition; Behavioral: Control Condition	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 181 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Personalized Health Behavior System to Promote Well-Being in Older Adults (FITTLE)
• Actual Study Start Date: November 26, 2018
• Actual Primary Completion Date: October 26, 2021
• Actual Study Completion Date: October 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in 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. Range (10+)

Secondary Outcome Measures :

1. Change in Timed Up and Go [ Time Frame: Baseline, 3 month follow-up and 6 month follow-up ]
   Measure of fall risk. A faster time indicates a better functional performance. Range (1+)

Other Outcome Measures:

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Florida

University of Miami Miller School of Medicine

Miami, Florida, United States, 33136

United States, New York

Weill Cornell Medicine

New York, New York, United States, 10065

Sponsors and Collaborators

Weill Medical College of Cornell University

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

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03538158
• Other Study ID Numbers: 1806019352; R01AG053163 ( U.S. NIH Grant/Contract )
• First Posted: May 25, 2018
• Last Update Posted: December 22, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Data will become available following the publication of the primary outcomes paper and will be available at request for 5 years.
• Access Criteria: Data will be available to investigators at request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:

Older adults; Physical well-being; Quality of life