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.

backgroundPhysical 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.

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

methodsThis study comprises a 3-arm parallel cluster randomized controlled trial (RCT) with low-resourced mothers living in New York City. We 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 peer support activities. Over 2 years, we will recruit a pilot wave followed by 7 additional waves, totaling 720 participants into 24 fitness classes. Physical activity is the primary outcome, measured using accelerometers, but secondary outcomes also include physical activity assessed using a self-reported questionnaire and attendance data. We will assess additional secondary outcomes (eg, health status, depression, and anxiety) and mediators or moderators (eg, social support and cohesion) with a baseline and follow-up questionnaire. The intention-to-treat analysis will use linear mixed-effects models 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 understand how real-world conditions shape the intervention implementation.

resultsThe study received funding from the US National Institute of Health, covering the period of time from April 1, 2023, through March 31, 2028. We received initial institutional review board approval in August 2023. The study is active and recruiting participants. As of the day of manuscript submission, we have enrolled 471 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, websites, events, and academic publications and conferences.

conclusionsThis cluster RCT tests whether access to childcare (an understudied structural barrier) and social support can increase physical activity. The study design and outcomes integrate ethnographic methods with a cluster RCT to better understand mechanisms and the impact of intersecting factors such as race or 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.

trial registrationClinicalTrials.gov NCT06654843; https://clinicaltrials.gov/study/NCT06654843. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71381.