A Personalized Health Behavior System
FITTLESenior
2 other identifiers
interventional
181
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 25, 2018
CompletedStudy Start
First participant enrolled
November 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedResults Posted
Study results publicly available
October 12, 2022
CompletedOctober 12, 2022
September 1, 2022
2.9 years
May 15, 2018
August 8, 2022
September 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Timed Up and Go
Baseline, 3 month follow-up and 6 month follow-up
Other Outcomes (4)
Change in Functional Health and Well-being as Measured by Modified SF-36
Baseline, 3 month follow-up and 6 month follow-up
Change in Loneliness as Measured by Loneliness Scale
Baseline, 3 month follow-up and 6 month follow-up
Change in Social Isolation as Measured by Friendship Scale
Baseline, 3 month follow-up and 6 month follow-up
- +1 more other outcomes
Study Arms (2)
Intervention condition - Fittle Senior
EXPERIMENTALParticipants will have access to the Fittle Senior System which will provide guided exercises and social support.
Control condition - paper and pencil
PLACEBO COMPARATORParticipants will have a written booklet with exercises that they may do it on their own.
Interventions
Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.
Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Cognitively impaired
- Visual or hearing impairment
- Actively engaged in structured physical exercise regularly
- Health conditions/illness that would affect participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Related Publications (1)
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.
PMID: 38902616DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chelsie Burchett
- Organization
- Weill Cornell Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Sara J. Czaja, PhD
Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
May 25, 2018
Study Start
November 26, 2018
Primary Completion
October 26, 2021
Study Completion
October 26, 2021
Last Updated
October 12, 2022
Results First Posted
October 12, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.