A Personalized Health Behavior System

NCT ID: NCT03538158

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2021-10-26

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.

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.

Conditions

Social Isolation; Aging; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention condition - Fittle Senior

Participants will have access to the Fittle Senior System which will provide guided exercises and social support.

Group Type: EXPERIMENTAL

Intervention Condition

Intervention Type: BEHAVIORAL

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

Control condition - paper and pencil

Participants will have a written booklet with exercises that they may do it on their own.

Group Type: PLACEBO_COMPARATOR

Control Condition

Intervention Type: BEHAVIORAL

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

Interventions

Intervention Condition

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

Intervention Type: BEHAVIORAL

Control Condition

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Florida Institute for Human and Machine Cognition

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara J. Czaja, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

University of Miami Miller School of Medicine

Miami, Florida, United States

Weill Cornell Medicine

New York, New York, United States

Countries

United States

References

Lieber SB, Moxley J, Mandl LA, Reid MC, Czaja SJ. Social support and physical activity: does general health matter? Eur Rev Aging Phys Act. 2024 Jun 20;21(1):16. doi: 10.1186/s11556-024-00347-6.

Reference Type: DERIVED

PMID: 38902616 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01AG053163

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1806019352

Identifier Type: -

Identifier Source: org_study_id