CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 181 enrolled
Drug / intervention
Intervention Condition +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03538158
NCT03538158N/ACompleted

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

Weill Medical College of Cornell University·interventional·Posted May 25, 2018·Updated Oct 12, 2022

In Brief

A clinical study evaluating Intervention Condition and Control Condition for Social Isolation and 2 related conditions. Completed, enrolled 181 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 25, 2018
Enrollment StartNov 26, 2018
Primary CompletionOct 26, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.1 years ago

Interventions

Intervention Conditionbehavioral

Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.

Control Conditionbehavioral

Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.