Recruiting

FT4WFree Time For Wellness 2+

Sponsor:

Columbia University

Code:

NCT06654843

Conditions

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Comparator Arm

Enhanced intervention arm

Study Details

Brief summary:

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.

Conditions

Physical Inactivity

Study ID

NCT06654843

Start date

Nov 15, 2024

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

630 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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.

Interventions

Comparator Arm

In addition to fitness classes, they will receive childcare in an adjacent space to the fitness class.

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 measure

Total minutes of time spent in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Baseline and follow-up between weeks 10-12 ]

Central Contacts and Locations

Central contacts

Lauren C Houghton, PhD

2123420246 lh2746@cumc.columbia.edu

Sherece Laine, MPH

9175747512 ssl2200@cumc.columbia.edu

Locations

Highbridge Park

Recruiting

New York, New York, United States, 10033

St. James Recreation

Recruiting

New York, New York, United States, 10468

Hunts Point Recreation Center

Recruiting

New York, New York, United States, 10474

More Information

Sponsor

Columbia University

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

motherhood
childcare
social cohesion
child
exercise
social networking
public health
community-based

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-11-12.