NCT06654843 · Columbia University
Free Time For Wellness 2+
(FT4W2+)
What this study is about
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.
View original scientific description
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.
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
Weekly MVPA, total physical activity, sedentary time, and sleep will be objectively assessed using a blinded research-grade wrist-worn accelerometer (Axivity AX3) in all groups.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- New York, New York
Collaborators
Monash University, Loughborough University, University of Iowa, Public Health Institute, Jovie USA, LLC, West Side Campaign Against Hunger, New York City Parks and Recreation, National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2025 · Source of record for eligibility and locations