Clinical trial NCT03538158: A Personalized Health Behavior System
Official title: A Personalized Health Behavior System to Promote Well-Being in Older Adults (FITTLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Aging
Physical Activity
Keywords: Older adults
Physical well-being
Quality of life
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Florida Institute for Human and Machine Cognition
First posted: 2018-05-25
Enrollment: 181
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: VO2 Max
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
Secondary outcomes:
measure: Timed Up and Go
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
Other outcomes:
measure: Change in Functional Health and Well-being as Measured by Modified SF-36
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Change in Loneliness as Measured by Loneliness Scale
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Change in Social Isolation as Measured by Friendship Scale
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Change in Social Support as Measured by Interpersonal Support Evaluation List - ISEL
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sara J. Czaja, PhD
role: PRINCIPAL_INVESTIGATOR
References: