A Personalized Health Behavior System (FITTLESenior)
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|ClinicalTrials.gov Identifier: NCT03538158|
Recruitment Status : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : March 9, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Social Isolation Aging Physical Activity||Behavioral: Intervention Condition Behavioral: Control Condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Personalized Health Behavior System to Promote Well-Being in Older Adults (FITTLE)|
|Actual Study Start Date :||November 26, 2018|
|Estimated Primary Completion Date :||August 20, 2021|
|Estimated Study Completion Date :||August 20, 2021|
Experimental: Intervention condition - Fittle Senior
Participants will have access to the Fittle Senior System which will provide guided exercises and social support.
Behavioral: Intervention Condition
Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.
Placebo Comparator: Control condition - paper and pencil
Participants will have a written booklet with exercises that they may do it on their own.
Behavioral: Control Condition
Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
- Change in VO2 max [ Time Frame: Baseline, 3 month follow-up and 6 month follow-up ]Higher score of VO2 max indicates more oxygen consumption during incremental exercise. Range (10+)
- Change in Timed Up and Go [ Time Frame: Baseline, 3 month follow-up and 6 month follow-up ]Measure of fall risk. A faster time indicates a better functional performance. Range (1+)
- Change in functional health and well-being as measured by modified SF-36 [ Time Frame: Baseline, 3 month follow-up and 6 month follow-up ]Higher score means better functional health and well-being. Range (0-1400)
- Change in loneliness as measured by Loneliness scale [ Time Frame: Baseline, 3 month follow-up and 6 month follow-up ]Higher score indicates a greater degree of loneliness. Range (0-80)
- Change in social isolation as measured by Friendship Scale [ Time Frame: Baseline, 3 month follow-up and 6 month follow-up ]Measures the level of social isolation. Lower score indicates less social isolation. Range (0-24)
- Change in social support as measured by Interpersonal Support Evaluation List - ISEL [ Time Frame: Baseline, 3 month follow-up and 6 month follow-up ]Measures the level of functional social support. Higher scores indicates better and more social support
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538158
|United States, Florida|
|University of Miami Miller School of Medicine|
|Miami, Florida, United States, 33136|
|United States, New York|
|Weill Cornell Medicine|
|New York, New York, United States, 10065|
|Principal Investigator:||Sara J. Czaja, PhD||Weill Medical College of Cornell University|