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Fittle Senior System (FittleSenior)

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ClinicalTrials.gov Identifier: NCT03538158
Recruitment Status : Not yet recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Florida Institute for Human and Machine Cognition
Information provided by (Responsible Party):
Sara J Czaja, University of Miami

May 15, 2018
May 25, 2018
May 25, 2018
July 1, 2018
July 1, 2020   (Final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Fittle Senior System
A Personalized Health Behavior System to Promote Well-Being in Older Adults -

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, 3mths post active intervention and 3mths post maintenance (6mths following active intervention) on measures of health and health behaviors, and indices of social support.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Isolated Older Adults
  • Behavioral: Intervention Condition
    Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.
  • Behavioral: Control Condition
    Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
  • Experimental: Intervention condition - Fittle Senior
    Participants will have access to the Fittle Senior System which will provide guided exercises and social support.
    Intervention: Behavioral: Intervention Condition
  • Placebo Comparator: Control condition - paper and pencil
    Participants will have a written booklet with exercises that they may do it on their own.
    Intervention: Behavioral: Control Condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
180
Same as current
April 30, 2021
July 1, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 65 years old
  • Self-identified as White, Black, or Hispanic
  • Speak English or Spanish
  • Able to read at the 6th grade
  • Socially isolated
  • Living alone
  • Planning to stay in the study geographical area for the duration of the study

Exclusion Criteria:

  • Cognitively impaired
  • Visual impairment
  • Actively engaged in structure physical exercise regularly
  • Lack of doctor's clearance to participate in the study
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Yes
Contact: Chin Chin Lee, MS, MSPH 305-355-9062 c.lee7@miami.edu
Contact: Daniel E. Jimenez, PhD 305-355-9063 dej18@miami.edu
United States
 
 
NCT03538158
20160128
R01AG053163 ( U.S. NIH Grant/Contract )
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Sara J Czaja, University of Miami
University of Miami
  • National Institute on Aging (NIA)
  • Florida Institute for Human and Machine Cognition
Principal Investigator: Sara J. Czaja, PhD University of Miami
University of Miami
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP