Free Time For Wellness 2+ (FT4W2+)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Inactivity
• Intervention / Treatment: Behavioral: Comparator Arm; Behavioral: Enhanced intervention arm

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.

• Study Type: Interventional
• Enrollment (Estimated): 630
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren C Houghton, PhD; Phone Number: 2123420246; Email: lh2746@cumc.columbia.edu
• Study Contact Backup: Name: Sherece Laine, MPH; Phone Number: 9175747512; Email: ssl2200@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10033
      • Recruiting
      • Highbridge Park
    • New York, New York, United States, 10029
      • Active, not recruiting
      • Thomas Jefferson Recreation Center
    • New York, New York, United States, 10039
      • Active, not recruiting
      • Jackie Robinson Recreation Center
    • New York, New York, United States, 10467
      • Active, not recruiting
      • Williamsbridge Oval
    • New York, New York, United States, 10468
      • Recruiting
      • St. James Recreation
    • New York, New York, United States, 10474
      • Recruiting
      • Hunts Point Recreation Center
    • New York, New York, United States, 11213
      • Active, not recruiting
      • St. John's Park Recreation Center
    • New York, New York, United States, 11216
      • Active, not recruiting
      • PS 003
    • New York, New York, United States, 11222
      • Active, not recruiting
      • McCarren Play Center
    • New York, New York, United States, 11368
      • Active, not recruiting
      • PS19

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm: No Intervention: Control Arm: Fitness classes only; There will be 21 Shape Up NYC classes offered weekly for one hour free of charge to consenting participants in all three arms with a total of 12 classes offered per participant. Weekly reminders for each class will be sent via automated text messages to individuals.
Active Comparator: Comparator Arm: Fitness classes + childcare; There will be 21 Shape Up NYC classes offered weekly for one hour free of charge to consenting participants in all three arms with a total of 12 classes offered per participant. Weekly reminders for each class will be sent via automated text messages to individuals.	Behavioral: Comparator Arm; In addition to fitness classes, they will receive childcare in an adjacent space to the fitness class.
Experimental: Enhanced intervention arm: Fitness classes + childcare + peer support; There will be 21 Shape Up NYC classes offered weekly for one hour free of charge to consenting participants in all three arms with a total of 12 classes offered per participant.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total minutes of time spent in Moderate to Vigorous Physical Activity (MVPA)	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.	Baseline and follow-up between weeks 10-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D-5L score	The EQ5D-5L standardized survey is a generic measure of health status that includes five dimensions: mobility, self-care, usual activities, pain, and anxiety/depression. The EQ-5D-5L index is measured on a total scale from 0 to 1, whereby 0 indicates death and 1 perfect health.	At baseline and follow-up between weeks 10-12
ICEpop CAPability measure for Adults (ICECAP-A) score	The ICECAP-A standardized survey captures the broader concept of well-being via five dimensions: feeling settled and secure; love, friendship, and support; being independent; achievement and progress; and enjoyment and pleasure. The ICECAP-A also generates a score between 0 to 1 where one equals 'full capability' and zero equals 'completely incapable'.	At baseline and follow-up between weeks 10-12
Attendance	Shape Up NYC takes attendance at each fitness class, and community champions will take attendance at the peer support activities to understand participation, retention, and attrition levels. Attendance rate of all fitness classes will be presented as the mean percent of attendance ([# of participants present in class] divided by [# of available slots] multiplied by 100) over 12 weeks.	12 weeks
Generalized Anxiety Disorder 2-item (GAD-2) score	The GAD-2 is a brief questionnaire that assesses patient anxiety. The total score range is 0-6, with a higher score indicating worse anxiety.	Baseline and follow-up between weeks 10-12
Patient Health Questionnaire-2 (PHQ-2)	PHQ-2 is a brief questionnaire that assesses frequency of depressed mood and anhedonia. The total score range is 0-6, with a higher score indicating worsening feelings of depression.	Baseline and follow-up between weeks 10-12
International Physical Activity Questionnaire (IPAQ) score	Self-reported physical activity data will be collected using IPAQ. IPAQ asks participants to report the types and frequency of physical activities they have participated in over 7 days. IPAQ score is expressed as median(MET)-min per week: [MET level] x [minutes of activity/day] x [days per week]. It is scored as follows: High: Any one of the following two criteria: Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week OR 7+ days of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week Moderate: Any one of the following three criteria: 3+ days of vigorous activity, at least 20 minutes per day OR 5+ days of moderate-intensity activity or walking of at least 30 minutes per day OR 5+ days of walking, moderate-intensity or vigorous intensity activities achieving a minimum of 600 MET-min/week. Low: Individuals who do not meet criteria for either category	Baseline and follow-up between weeks 10-12

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); University of Iowa; Monash University; Loughborough University; Jovie USA, LLC; Public Health Institute; West Side Campaign Against Hunger; New York City Parks and Recreation

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: exercise; child; community-based; public health; social networking; childcare; motherhood; social cohesion
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Sedentary Behavior
• Other Study ID Numbers: AAAU8303 Wave 2+; 5R01MD018609 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Based on ethical considerations, only the quantitative aggregated data produced in the course of the project will be preserved and shared. The final dataset will include self-reported demographic and behavioral data from surveys and accelerometer data aggregated at the cluster level. To facilitate interpretation of the data, a data dictionary and copies of blank questionnaires will be created, shared, and associated with the relevant datasets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No