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N/A N=181 Randomized Double-blind Prevention

A Personalized Health Behavior System

Social Isolation · Aging · Physical Activity

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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