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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

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


Condition or disease Intervention/treatment Phase
Isolated Older Adults Behavioral: Intervention Condition Behavioral: Control Condition Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Personalized Health Behavior System to Promote Well-Being in Older Adults -
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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+)

  2. 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+)

  3. 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)

  4. 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)

  5. 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)

  6. 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



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Chin Chin Lee, MS, MSPH 305-355-9062 c.lee7@miami.edu
Contact: Daniel E. Jimenez, PhD 305-355-9063 dej18@miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Institute on Aging (NIA)
Florida Institute for Human and Machine Cognition
Investigators
Principal Investigator: Sara J. Czaja, PhD University of Miami

Responsible Party: Sara J Czaja, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03538158     History of Changes
Other Study ID Numbers: 20160128
R01AG053163 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sara J Czaja, University of Miami:
Older adults
Physical well-being
Quality of life