N/A
N=181
A Personalized Health Behavior System
Social Isolation · Aging · Physical Activity
Bottom Line
View on ClinicalTrials.gov: NCT03538158 ↗Enrolled (actual)
181
Serious AEs
3.3%
Results posted
Oct 2022
Primary outcome: Primary: VO2 Max — 16.6; 16.8; 15.7; 18.5 mL/kg/min — p=.82
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention Condition (Behavioral); Control Condition (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VO2 Max |
16.6; 16.8; 15.7; 18.5; 20.2; 17.3 | .82 |
| SECONDARY Timed Up and Go |
10.5; 10; 9.2; 8.6; 10; 8.6 | .97 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03538158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.