Free Time For Wellness 2+

Official title

Cluster Randomized Controlled Trial to Promote Physical Activity Among Low-resourced Mothers in New York City: Protocol for the Free Time for Wellness (FT4W) Effectiveness Trial.

Overview

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.

Detailed description

Physical inactivity is particularly prevalent in women of low socioeconomic position (SEP) (60% are inactive), suggesting that there are structural barriers to being physically active. This study will test the effectiveness of an intervention to increase physical activity among mothers of low SEP, where there is high risk of chronic disease and significant potential to make an impact on these health disparities.

This study comprises a 3-arm parallel cluster randomized controlled trial with low-resourced mothers living in New York City. The study team will randomize fitness class sites (clusters) into Arm A (contact control), receipt of free weekly fitness classes; Arm B, receipt of free childcare combined with free weekly fitness classes; and Arm C, receipt of free childcare combined with free weekly fitness classes and, plus peer support activities. Over two years the study team will recruit eight waves totaling 630 participants into 21 fitness classes. Physical activity is the primary outcome measured using accelerometers, a self-reported questionnaire, and attendance data. Secondary outcomes (e.g., health status) and mediators/moderators (e.g., social support and cohesion) will be assessed with a baseline and follow-up questionnaire. Ethnographic methods will be used to examine how intersecting forms of social inequality shape women's experiences of physical activity and to understand how real-world conditions shape the intervention implementation. The intention-to-treat analysis will employ linear mixed-effects models (LMM) to assess the main intervention effects on physical activity outcomes and other secondary outcomes.

Interventions

• Behavioral Comparator Arm
  In addition to fitness classes, they will receive childcare in an adjacent space to the fitness class.
• Behavioral Enhanced intervention arm
  In 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.

Primary outcome measures

• Total minutes of time spent in Moderate to Vigorous Physical Activity (MVPA) [Time frame: Baseline and follow-up between weeks 10-12]

Secondary outcome measures (6)

• EQ5D-5L score [Time frame: At baseline and follow-up between weeks 10-12]
• ICEpop CAPability measure for Adults (ICECAP-A) score [Time frame: At baseline and follow-up between weeks 10-12]
• Attendance [Time frame: 12 weeks]
• Generalized Anxiety Disorder 2-item (GAD-2) score [Time frame: Baseline and follow-up between weeks 10-12]
• Patient Health Questionnaire-2 (PHQ-2) [Time frame: Baseline and follow-up between weeks 10-12]
• International Physical Activity Questionnaire (IPAQ) score [Time frame: Baseline and follow-up between weeks 10-12]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 10 centers

• Thomas Jefferson Recreation Center — New York
• Highbridge Park — New York
• Jackie Robinson Recreation Center — New York
• Williamsbridge Oval — New York
• St. James Recreation — New York
• Hunts Point Recreation Center — New York
• St. John's Park Recreation Center — New York
• PS 003 — New York
• … and 2 more centers

Publications

• Watterson J, Magsamen-Conrad K, Gokal K, Oakley-Girvan I, Hirsch JS, Qian M, Buchsbaum R, Niles C, Van Horn K, Moshier S, Martinez A, Garcia Flores A, Laine S, Vega M, Houghton LC. Cluster Randomized Controlled Trial to Promote Physical Activity Among Low-Resourced Mothers in New York City: Protocol for the Free Time for Wellness Effectiveness Trial. JMIR Res Protoc. 2026 Jan 13;15:e71381. doi: 10 PMID 41529256

Identifiers

NCT: NCT06654843 · AAAU8303 Wave 2+ · 5R01MD018609

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗