New York, New York 10065

  • Physical Activity

Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

1806019352


NCT ID:

NCT03538158


Secondary ID:

R01AG053163


Study Acronym:

FITTLESenior


Brief Title:

A Personalized Health Behavior System


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Weill Medical College of Cornell University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

181


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sara J. Czaja, PhD
Principal Investigator
Weill Medical College of Cornell University

Study Dates

Start Date:November 26, 2018
Completion Date:August 20, 2021
Completion Type:Anticipated
Primary Completion Date:August 20, 2021
Primary Completion Type:Anticipated
Verification Date:March 2021
Last Changed Date:March 5, 2021
First Received Date:May 15, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in VO2 max
Time Frame:Baseline, 3 month follow-up and 6 month follow-up
Safety Issues:False
Description:Higher score of VO2 max indicates more oxygen consumption during incremental exercise. Range (10+)
Outcome Type:Secondary Outcome
Measure:Change in Timed Up and Go
Time Frame:Baseline, 3 month follow-up and 6 month follow-up
Safety Issues:False
Description:Measure of fall risk. A faster time indicates a better functional performance. Range (1+)

Study Interventions

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

Study Arms

Study Arm Type:Experimental
Arm Name:Intervention condition - Fittle Senior
Description:Participants will have access to the Fittle Senior System which will provide guided exercises and social support.
Study Arm Type:Placebo Comparator
Arm Name:Control condition - paper and pencil
Description:Participants will have a written booklet with exercises that they may do it on their own.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Weill Medical College of Cornell University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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