Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG053163 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Florida Institute for Human and Machine Cognition | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention condition - Fittle Senior | Experimental | Participants will have access to the Fittle Senior System which will provide guided exercises and social support. |
|
| Control condition - paper and pencil | Placebo Comparator | Participants will have a written booklet with exercises that they may do it on their own. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Condition | Behavioral | Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VO2 Max | Higher score of VO2 max indicates more oxygen consumption during incremental exercise. | Baseline, 3 month follow-up and 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Health and Well-being as Measured by Modified SF-36 | Higher score means better functional health and well-being. Range (0-1400) | Baseline, 3 month follow-up and 6 month follow-up |
| Change in Loneliness as Measured by Loneliness Scale |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sara J. Czaja, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States | ||
| Weill Cornell Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38902616 | Derived | 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. |
Not provided
Not provided
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.
Data will become available following the publication of the primary outcomes paper and will be available at request for 5 years.
Data will be available to investigators at request.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Condition - Fittle Senior | Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study. |
| FG001 | Control Condition - Paper and Pencil | Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Condition - Fittle Senior | Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | VO2 Max | Higher score of VO2 max indicates more oxygen consumption during incremental exercise. | The number analyzed is different than the number of subjects in the participant flow because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19. | Posted | Mean | Standard Deviation | mL/kg/min | Baseline, 3 month follow-up and 6 month follow-up |
|
The 6 months the participant was enrolled in the study.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Condition - Fittle Senior | Participants will have access to the Fittle Senior System which will provide guided exercises and social support. Intervention Condition: Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart surgery | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsie Burchett | Weill Cornell Medicine | 212-746-1417 | cob2014@med.cornell.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2021 | Aug 4, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012934 | Social Isolation |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Condition | Behavioral | Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study. |
|
| Baseline, 3 month follow-up and 6 month follow-up |
Higher score indicates a greater degree of loneliness. Range (0-80)
| Baseline, 3 month follow-up and 6 month follow-up |
| Change in Social Isolation as Measured by Friendship Scale | Measures the level of social isolation. Lower score indicates less social isolation. Range (0-24) | Baseline, 3 month follow-up and 6 month follow-up |
| Change in Social Support as Measured by Interpersonal Support Evaluation List - ISEL | Measures the level of functional social support. Higher scores indicates better and more social support | Baseline, 3 month follow-up and 6 month follow-up |
| New York |
| New York |
| 10065 |
| United States |
| Control Condition - Paper and Pencil |
Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| VO2 Max | The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19. | Mean | Standard Deviation | mL/kg/min |
|
| 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. | The number analyzed is different than the overall number of baseline participants because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19. | Mean | Standard Deviation | Seconds |
|
Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study. |
|
|
|
| Secondary | 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. | The number analyzed is different than the number of subjects in the participant flow because some participants were loss to follow up, withdrew from the study, or the data was not collected due to COVID-19. | Posted | Mean | Standard Deviation | Seconds | Baseline, 3 month follow-up and 6 month follow-up |
|
|
|
|
| Other Pre-specified | Change in Functional Health and Well-being as Measured by Modified SF-36 | Higher score means better functional health and well-being. Range (0-1400) | Not Posted | Baseline, 3 month follow-up and 6 month follow-up | Participants |
| Other Pre-specified | Change in Loneliness as Measured by Loneliness Scale | Higher score indicates a greater degree of loneliness. Range (0-80) | Not Posted | Baseline, 3 month follow-up and 6 month follow-up | Participants |
| Other Pre-specified | Change in Social Isolation as Measured by Friendship Scale | Measures the level of social isolation. Lower score indicates less social isolation. Range (0-24) | Not Posted | Baseline, 3 month follow-up and 6 month follow-up | Participants |
| Other Pre-specified | Change in Social Support as Measured by Interpersonal Support Evaluation List - ISEL | Measures the level of functional social support. Higher scores indicates better and more social support | Not Posted | Baseline, 3 month follow-up and 6 month follow-up | Participants |
| 0 |
| 92 |
| 3 |
| 92 |
| 4 |
| 92 |
| EG001 | Control Condition - Paper and Pencil | Participants will have a written booklet with exercises that they may do it on their own. Control Condition: Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study. | 0 | 89 | 3 | 89 | 5 | 89 |
| Cancer | General disorders | Non-systematic Assessment |
|
| Kidney Stone | Renal and urinary disorders | Non-systematic Assessment |
|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Kidney Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Shoulder Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 3 Month Follow-Up |
|
|
| 6 Month Follow-Up |
|
|