Aging, Physical Activity, Social Isolation
Conditions
Keywords
Older adults, Physical well-being, Quality of life
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, 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.
Interventions
BEHAVIORALIntervention Condition
Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.
BEHAVIORALControl Condition
Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
Sponsors
National Institute on Aging (NIA)
Florida Institute for Human and Machine Cognition
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* Cognitively impaired * Visual or hearing impairment * Actively engaged in structured physical exercise regularly * Health conditions/illness that would affect participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2 Max | Baseline, 3 month follow-up and 6 month follow-up | Higher score of VO2 max indicates more oxygen consumption during incremental exercise. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go | Baseline, 3 month follow-up and 6 month follow-up | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Health and Well-being as Measured by Modified SF-36 | 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 | 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 | 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 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 92 |
| 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. | 89 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 7 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Intervention Condition - Fittle Senior | Control Condition - Paper and Pencil | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 70 Participants | 71 Participants | 141 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 17 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants | 76 Participants | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 11 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 72 Participants | 74 Participants | 146 Participants |
| Sex: Female, Male Female | 74 Participants | 67 Participants | 141 Participants |
| Sex: Female, Male Male | 15 Participants | 20 Participants | 35 Participants |
| Timed Up and Go | 10.5 Seconds STANDARD_DEVIATION 3 | 10.2 Seconds STANDARD_DEVIATION 2.6 | 10.4 Seconds STANDARD_DEVIATION 2.8 |
| VO2 Max | 16.6 mL/kg/min STANDARD_DEVIATION 5.4 | 16.8 mL/kg/min STANDARD_DEVIATION 4.9 | 16.7 mL/kg/min STANDARD_DEVIATION 5.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 89 |
| other Total, other adverse events | 4 / 92 | 5 / 89 |
| serious Total, serious adverse events | 3 / 92 | 3 / 89 |
Outcome results
Primary
VO2 Max
Higher score of VO2 max indicates more oxygen consumption during incremental exercise.
Time frame: Baseline, 3 month follow-up and 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Condition - Fittle Senior | VO2 Max | 6 month follow-up | 20.2 mL/kg/min | Standard Deviation 1.4 |
| Intervention Condition - Fittle Senior | VO2 Max | Baseline | 16.6 mL/kg/min | Standard Deviation 5.4 |
| Intervention Condition - Fittle Senior | VO2 Max | 3 month follow-up | 15.7 mL/kg/min | Standard Deviation 4.4 |
| Control Condition - Paper and Pencil | VO2 Max | Baseline | 16.8 mL/kg/min | Standard Deviation 4.9 |
| Control Condition - Paper and Pencil | VO2 Max | 3 month follow-up | 18.5 mL/kg/min | Standard Deviation 5.6 |
| Control Condition - Paper and Pencil | VO2 Max | 6 month follow-up | 17.3 mL/kg/min | Standard Deviation 2 |
p-value: 0.8295% CI: [-287.7, 299.1]Mixed Models Analysis
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.
Time frame: Baseline, 3 month follow-up and 6 month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Condition - Fittle Senior | Timed Up and Go | Baseline | 10.5 Seconds | Standard Deviation 3 |
| Intervention Condition - Fittle Senior | Timed Up and Go | 3 Month Follow-Up | 9.2 Seconds | Standard Deviation 1.8 |
| Intervention Condition - Fittle Senior | Timed Up and Go | 6 Month Follow-Up | 10 Seconds | Standard Deviation 2.3 |
| Control Condition - Paper and Pencil | Timed Up and Go | Baseline | 10 Seconds | Standard Deviation 2.6 |
| Control Condition - Paper and Pencil | Timed Up and Go | 3 Month Follow-Up | 8.6 Seconds | Standard Deviation 3.9 |
| Control Condition - Paper and Pencil | Timed Up and Go | 6 Month Follow-Up | 8.6 Seconds | Standard Deviation 1.1 |
p-value: 0.9795% CI: [-3.5, 4.4]Mixed Models Analysis
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)
Time frame: Baseline, 3 month follow-up and 6 month follow-up
Other Pre-specified
Change in Loneliness as Measured by Loneliness Scale
Higher score indicates a greater degree of loneliness. Range (0-80)
Time frame: Baseline, 3 month follow-up and 6 month follow-up
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)
Time frame: Baseline, 3 month follow-up and 6 month follow-up
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
Time frame: Baseline, 3 month follow-up and 6 month follow-up