Social Isolation Clinical Trial
Official title:
Using Social Connectedness to Increase Physical Activity
Verified date | October 2023 |
Source | Carnegie Mellon University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized controlled trial will test the effectiveness of social incentives relative to traditional incentives in promoting walking behavior among college students (N=200). Participants who are rewarded for walking together will be compared to those who are rewarded for walking even when alone. Research participants will download activity tracking apps (Fitbit app and AWARE app) that provide activity and location data. Participants will be consented and then randomized to one of two incentive schemes for walking. Over a 2-week intervention period, the standard incentive group will earn $2 per day when they meet their walking goal regardless of whether they walk alone or with others. The social incentive group will earn $1 per day when they reach their walking goal plus an additional $1 when they walk at least 2000 steps with their walking partner. The incentive scheme will be in place for 2-weeks, preceded by a 1-week baseline period and followed by a 2-week follow-up period.
Status | Completed |
Enrollment | 172 |
Est. completion date | January 4, 2021 |
Est. primary completion date | November 25, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18+ - Able to read and understand English-language surveys - Own either iPhone or Android smartphones - Willing to carry the smart phone during the study period and to respond to daily texts or emails from the study team - Registered for the study as a dyad (friend pairs), with one member of the dyad a Carnegie Mellon University student Exclusion Criteria: • Contraindications for increased physical activity |
Country | Name | City | State |
---|---|---|---|
United States | Carnegie Mellon University | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Carnegie Mellon University | University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Intervention Period (Weeks 2 and 3) | Change in mean daily steps walked from baseline (week 1) to intervention period (weeks 2 and 3), as recorded on the FitBit app | week 2-3 | |
Primary | Change in Mean Daily Steps Walked From Baseline Period (Week 1) to Follow-up Period (Weeks 4-5) | Change in mean daily steps walked from baseline to follow-up period, as recorded on the FitBit app | week 4-5 | |
Primary | Mean Number of Days Met Daily Step Goal During Intervention Period (Weeks 2-3) Minus Mean Number of Days Met Same Level of Walking in Baseline Period (Week 1) | Mean number of days when an individual's number of steps walked was at or above daily goal during the intervention period (weeks 2 & 3) minus the mean number of days the individual's number of step's walking was at or above that same level during the baseline period (week 1) | week 2-3 | |
Primary | Mean Number of Days Met Daily Step Goal During Follow-up Period (Weeks 4-5) Minus Mean Number of Days Met Same Level of Walking in Baseline Period (Week 1) | Mean number of days when an individual's number of steps walked was at or above daily goal during the follow-up period (weeks 4 & 5) minus the mean number of days the individual's number of step's walking was at or above that same level during the baseline period (week 1) | week 4-5 | |
Primary | Change in Score on University of California Los Angeles (UCLA) Loneliness Scale (Survey Measure) | 20-item scale measuring subjective feelings of loneliness and social isolation. Minimum score = 0; maximum score = 60; higher scores indicate more loneliness. We computed the difference in score from baseline (beginning of week 1) to end of study (end of week 5). | week 5 | |
Secondary | Fraction of Days Participant Walked Together With Partner (Self Report) During Intervention Period (Weeks 2-3) | Fraction of days with self report of walking at least 2,000 steps with another participant during intervention period (weeks 2-3) | week 2-3 | |
Secondary | Fraction of Days Participant Walked Together With Partner (Self Report) During Follow-up Period (Weeks 4-5) | Fraction of days with self report of walking at least 2,000 steps with another participant during follow-up period (weeks 3-5) | week 4-5 | |
Secondary | Proportion of Days Participant Walked Together With Partner (Coded) | A machine learning (ML) algorithm will compare the walking records from the Aware app of each dyad of participants and assess whether they walked together on each day | week 2-3 | |
Secondary | Proportion of Days Participant Walked Together With Partner (Coded) | A machine learning (ML) algorithm will compare the walking records from the Aware app of each dyad of participants and assess whether they walked together on each day | week 4-5 |
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