Cluster Randomised Controlled Trial to Promote Physical Activity Among Low-resourced Mothers in New York City: Protocol for the Free Time for Wellness (FT4W) Effectiveness Trial (Preprint)
Authors: Houghton Lauren , Magsamen-Conrad Kate , Gokal Kajal , Oakley-Girvan Ingrid , Hirsch Jennifer , Qian Min , Buchsbaum Richard , Niles Charlene , Van Horn Kendra , Moshier Stephanie , Martinez Andreina , Flores Avery , Laine Sherece , Vega Marilisa 
Published: February 2025

BACKGROUND

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.

OBJECTIVE

The broad objective of this study is to test the effectiveness of Free Time for Wellness (FT4W), a multilevel intervention to increase physical activity among low-resourced mothers.

METHODS

This study comprises a 3-arm parallel cluster randomised controlled trial with low-resourced mothers living in New York City. We will randomise 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 peer support activities. Over two years we will recruit a pilot wave followed by seven additional waves totalling 720 participants into 24 fitness classes. Physical activity is the primary outcome, measured using accelerometers, a self-reported questionnaire, and attendance data. We will assess secondary outcomes (e.g., health status) and mediators/moderators (e.g., social support and cohesion) with a baseline and follow-up questionnaire. 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. Ethnographic methods will examine how intersecting forms of social identity shape women’s experiences of physical activity and to understand how real-world conditions shape the intervention implementation.

RESULTS

The study is active and recruiting participants. Data collection is anticipated to occur until September 2026 for primary completion. The estimated study completion date is December 2026. Dissemination of the results will take place with participants, community members, partners, and researchers through methods such as reports, web sites, events, and academic publications and conferences.

CONCLUSIONS

This cluster-RCT tests a structural barrier to physical activity for mothers, lack of childcare, which is understudied. The study design and outcomes are geared toward integrating ethnographic methods with a cluster RCT to better understand mechanisms and the impact of intersecting factors such as race/ethnicity, culture, gender, and socioeconomic position. The study leverages widely accessible, existing resources to promote physical activity and foster social support with the ultimate goal of assessing the effect of childcare access on parental health.

CLINICALTRIAL

This protocol was registered with ClinicalTrials.gov (Reference Number NCT06654843).