N/A
N=80
Free Time For Wellness Pilot Effectiveness Trial
Physical Inactivity
Bottom Line
View on ClinicalTrials.gov: NCT06474715 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) — 548; 512; 354; 737 minutes of MVPA per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arms (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) |
548; 512; 354; 737; 479; 404 | — |
| SECONDARY EQ5D-5L Score |
0.86; 0.89; 0.90; 0.87; 0.91; 0.92 | — |
| SECONDARY ICEpop CAPability Measure for Adults (ICECAP-A) Score |
0.39; 0.36; 0.44; 0.41; 0.32; 0.34 | — |
| SECONDARY Attendance |
0.13; 0.19; 0.22 | — |
| SECONDARY Generalized Anxiety Disorder 2-item (GAD-2) Score |
1.6; 1.6; 1.5; 1.8; 1.3; 1.4 | — |
| SECONDARY Patient Health Questionnaire-2 (PHQ-2) |
1.1; 1.3; 1.7; 1.2; 1.2; 1.3 | — |
| SECONDARY International Physical Activity Questionnaire (IPAQ) Score |
3065; 2840; 2449; 2652; 2054; 2088 | — |
Summary
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 pilot test the Free Time for Wellness (FT4W), an innovative multilevel physical activity intervention to increase physical activity among low-resourced mothers.
Eligibility Criteria
Inclusion Criteria
- Understand/speak English or Spanish
- Have children <12 years old
- Own a mobile phone
- Live in the zip code surrounding as Shape Up NYC sites
Exclusion Criteria
- Total household income being greater than 165% of the area median income (calculated by household size).
Data sourced from ClinicalTrials.gov (NCT06474715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.