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
Bibliographic record
Abstract
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, a multilevel intervention to increase physical activity among low-resourced mothers. METHODS: This 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. RESULTS: The 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. CONCLUSIONS: This 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 REGISTRATION: ClinicalTrials.gov NCT06654843; https://clinicaltrials.gov/study/NCT06654843. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71381.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.019 | 0.022 |
| Meta-epidemiology (narrow) | 0.006 | 0.002 |
| Meta-epidemiology (broad) | 0.010 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.002 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.006 | 0.007 |
| Insufficient payload (model declined to judge) | 0.074 | 0.009 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".