Social IsolationFITTLESeniorNCT03538158
A Personalized Health Behavior System
A study testing Intervention Condition in people with Social Isolation and Aging, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Aging, Physical Activity
- What is being tested?
- Intervention Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Nov 2018to 26 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Cognitively impaired
- Visual or hearing impairment
- Actively engaged in structured physical exercise regularly
- Health conditions/illness that would affect participation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami Miller School of Medicine
Miami, Florida, 33136
Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: A Personalized Health Behavior System to Promote Well-Being in Older Adults (FITTLE)
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.
Read the detailed description
The proposed study will evaluate a new tablet-based dynamic system: the Fittle Senior System (FSS) that will provide: (1) personalized, goal-directed behavior-change programs for improved diet and increased physical activity and (2) online social interaction and support from small teams pursuing similar goals. The system builds on two technology-based systems developed by the investigative team: (1) the computer-based PRISM system (Czaja et al., 2015), designed for older populations to support social connectivity and well-being, and (2) the Fittle mobile platform (PARC) designed to support positive health behavior change through integrated online social support and personalized coaching based on artificial intelligence (AI). The Fittle program is based on Self-efficacy and Social Cognitive Theory (Bandura, 1998, 2001), Goal Setting (Locke \& Latham, 2002) and the Theory of Planned Behavior (Ajzen, 1991). Fittle provides support for individuals and teams to progress through lifestyle challenges (e.g., poor eating habits, sedentary behavior), helping individuals master one health improving habit after another in a way that builds on previous achievements. Individuals choose from a variety of challenges to accomplish goals via an intelligent coaching agent and personalized, engaging user experiences. The objective is to maintain and reinforce perceived self-efficacy with daily goals that are perceived as being achievable, and to improve motivation and ability with goals that are perceived as not too easy. The program provides encouragement and social support through a team component. Thus, Fittle is designed to reinforce and build self-efficacy and positive attitudes.
- Conditions
- Social Isolation, Aging, Physical Activity
- Being tested
- Intervention Condition, Control Condition
- Keywords
- Older adults, Physical well-being, Quality of life
- Medical subject headings
- Social Isolation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ConditionBehavioural
Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.
Control ConditionBehavioural
Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition - Fittle Senior | Experimental | Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Receives: Behavioral: Intervention Condition |
| Control condition - paper and pencil | Placebo comparator | Participants will have a written booklet with exercises that they may do it on their own. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 Max
Higher score of VO2 max indicates more oxygen consumption during incremental exercise.
Measured: Baseline, 3 month follow-up and 6 month follow-up
Secondary outcomes (1)
Timed Up and Go
To start the TUG, you will sit in the chair with your arms resting comfortably on your lap or at your sides.
The test begins when the therapist says "Go" and starts the stopwatch. You would then be timed as you rise from the chair, walk three meters, turn around, return to the chair, and sit down.
The recorded time on the stopwatch is the TUG score. Measure to assess mobility. A faster time indicates a better functional performance.
An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Measured: Baseline, 3 month follow-up and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start26 Nov 2018
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Florida Institute for Human and Machine Cognition
- Responsible party
- Sponsor
- Investigators
- Sara J. Czaja, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538158
- Sponsor's protocol ID
- 1806019352
- Other IDs
- R01AG053163
- Acronym
- FITTLESenior
- Status last verified
- Sep 2022
- First submitted
- 15 May 2018
- Last updated
- 12 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with investigators upon request. This data will include sociodemographic data and outcome measures including SF-36, Loneliness Scale, Friendship Scale and Interpersonal Support Evaluation List (ISEL) scores. IPD will be free from any Personal Health Identifiers.
Publications
Lieber SB, Moxley J, Mandl LA, Reid MC, Czaja SJ. Social support and physical activity: does general health matter? Eur Rev Aging Phys Act. 2024 Jun 20;21(1):16. doi: 10.1186/s11556-024-00347-6.
PubMed 38902616
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Health Behavior System to Promote Well-Being in Older Adults (FITTLE)
- ClinicalTrials.gov ID
- NCT03538158
- Acronym / sponsor ID
- FITTLESenior / 1806019352
- Conditions
- Social Isolation, Aging, Physical Activity
- Keywords
- Older adults, Physical well-being, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Florida Institute for Human and Machine Cognition
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Posted 12 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed study will evaluate a new tablet-based dynamic system: the Fittle Senior System (FSS) that will provide: (1) personalized, goal-directed behavior-change programs for improved diet and increased physical activity and (2) online social interaction and support from small teams pursuing similar goals. The system builds on two technology-based systems developed by the investigative team: (1) the computer-based PRISM system (Czaja et al., 2015), designed for older populations to support social connectivity and well-being, and (2) the Fittle mobile platform (PARC) designed to support positive health behavior change through integrated online social support and personalized coaching based on artificial intelligence (AI). The Fittle program is based on Self-efficacy and Social Cognitive Theory (Bandura, 1998, 2001), Goal Setting (Locke \& Latham, 2002) and the Theory of Planned Behavior (Ajzen, 1991). Fittle provides support for individuals and teams to progress through lifestyle challenges (e.g., poor eating habits, sedentary behavior), helping individuals master one health improving habit after another in a way that builds on previous achievements. Individuals choose from a variety of challenges to accomplish goals via an intelligent coaching agent and personalized, engaging user experiences. The objective is to maintain and reinforce perceived self-efficacy with daily goals that are perceived as being achievable, and to improve motivation and ability with goals that are perceived as not too easy. The program provides encouragement and social support through a team component. Thus, Fittle is designed to reinforce and build self-efficacy and positive attitudes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention condition - Fittle Senior | Experimental | Behavioral: Intervention ConditionParticipants will have access to the Fittle Senior System which will provide guided exercises and social support. |
| Control condition - paper and pencil | Placebo comparator | Behavioral: Control ConditionParticipants will have a written booklet with exercises that they may do it on their own. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- Cognitively impaired
- Visual or hearing impairment
- Actively engaged in structured physical exercise regularly
- Health conditions/illness that would affect participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ConditionParticipants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study. | Behavioural | Intervention condition - Fittle Senior |
| Control ConditionParticipants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study. | Behavioural | Control condition - paper and pencil |
Primary outcome
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.
1 secondary outcome
Timed Up and Go
Time frame: Baseline, 3 month follow-up and 6 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38902616Lieber SB, Moxley J, Mandl LA, Reid MC, Czaja SJ. Social support and physical activity: does general health matter? Eur Rev Aging Phys Act. 2024 Jun 20;21(1):16. doi: 10.1186/s11556-024-00347-6.
- Individual participant dataSharing planned: Yes. IPD will be shared with investigators upon request. This data will include sociodemographic data and outcome measures including SF-36, Loneliness Scale, Friendship Scale and Interpersonal Support Evaluation List (ISEL) scores. IPD will be free from any Personal Health Identifiers.
Related trials for Social Isolation
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Social Isolation in Older Adults, Poverty
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Improving Diet Quality of Community-Dwelling Seniors Using a Community-Based Participatory Approach
Diet Quality, Social Isolation in Older Adults
Recruiting
Social Connection Collective for Older Adults in Subsidized Housing
Social Isolation in Older Adults, Social Isolation or Loneliness
Not yet recruitingObservational study
The Impact of Long-term Isolation in Antarctica on Social Touch and Its Underlying Biological Mechanisms in Winter-over Crew Members, Assessed During Their Stay Using Standardized Touch Stimulation, Computer-based Touch Sensitivity Tests, Questionnaires and Biological Markers.
Social Isolation, Isolated Confined and Extreme Conditions
Active, not recruiting
Enhancing Wellbeing in Community Dwelling Seniors Through Structured Arts-Based Programmes in the Active Ageing Centres: A Mixed Method Study.
Wellbeing, Social Isolation in Older Adults
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara J. Czaja, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Condition in people with Social Isolation and Aging, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 Max (time frame: Baseline, 3 month follow-up and 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.