Free Time For Wellness 2+
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT06654843
- Status
- Recruiting
Conditions
- Physical Inactivity
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Comparator Arm — BEHAVIORALIn addition to fitness classes, they will receive childcare in an adjacent space to the fitness class.
- Enhanced intervention arm — BEHAVIORALIn addition to fitness classes, they will receive childcare in an adjacent space to the fitness class. In addition to childcare, Arm C will also receive peer support activities. Peer support activities will consist of group volunteer activities at food pantries, free deliveries of food pantry groceries, and group play dates at local playgrounds. A Community Champion will also facilitate group text messages.
Study Details
Physical inactivity is pervasive and prevalent in the United States, particularly among women of low socioeconomic position, and women with children. Structural and social barriers make active leisure time a rare commodity creating a pressing health issue because physical inactivity increases the risk of chronic diseases and poor health. The broad objective of this study is to test the effectiveness of Free Time for Wellness (FT4W), an innovative multilevel physical activity intervention to increase physical activity among low-resourced mothers.
Key Dates
- Start date
- Nov 15, 2024
- Status verified
- Nov 2025
- Primary completion
- Sep 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 630 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- No Intervention: Control Arm: No Intervention: Control Arm: Fitness classes onlyThere will be 21 Shape Up NYC classes offered weekly for one hour free of charge to consenting participants in all three arms with a total of 12 classes offered per participant. Weekly reminders for each class will be sent via automated text messages to individuals.
- Active Comparator: Comparator Arm: Fitness classes + childcareThere will be 21 Shape Up NYC classes offered weekly for one hour free of charge to consenting participants in all three arms with a total of 12 classes offered per participant. Weekly reminders for each class will be sent via automated text messages to individuals.
- Experimental: Enhanced intervention arm: Fitness classes + childcare + peer supportThere will be 21 Shape Up NYC classes offered weekly for one hour free of charge to consenting participants in all three arms with a total of 12 classes offered per participant.
Primary Outcome Measure
Total minutes of time spent in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Baseline and follow-up between weeks 10-12 ]
Central Contacts
- Lauren C Houghton, PhD2123420246
- Sherece Laine, MPH9175747512
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Highbridge Park | New York | New York | 10033 | - |
| Hunts Point Recreation Center | New York | New York | 10474 | - |
| Jackie Robinson Recreation Center | New York | New York | 10039 | - |
| McCarren Play Center | New York | New York | 11222 | - |
| PS 003 | New York | New York | 11216 | - |
| PS19 | New York | New York | 11368 | - |
| St. James Recreation | New York | New York | 10468 | - |
| St. John's Park Recreation Center | New York | New York | 11213 | - |
| Thomas Jefferson Recreation Center | New York | New York | 10029 | - |
| Williamsbridge Oval | New York | New York | 10467 | - |
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