NCT06654843

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Nov 2024Dec 2026

First Submitted

Initial submission to the registry

October 21, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

October 21, 2024

Last Update Submit

November 10, 2025

Conditions

Physical Inactivity

Keywords

motherhoodchildcaresocial cohesionchildexercisesocial networkingpublic healthcommunity-based

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • EQ5D-5L score

    At baseline and follow-up between weeks 10-12

  • ICEpop CAPability measure for Adults (ICECAP-A) score

    At baseline and follow-up between weeks 10-12

  • Attendance

    12 weeks

  • Generalized Anxiety Disorder 2-item (GAD-2) score

    Baseline and follow-up between weeks 10-12

  • Patient Health Questionnaire-2 (PHQ-2)

    Baseline and follow-up between weeks 10-12

  • +1 more secondary outcomes

Study Arms (3)

Control Arm: No Intervention: Control Arm: Fitness classes only

NO INTERVENTION

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.

Comparator Arm: Fitness classes + childcare

ACTIVE COMPARATOR

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

Enhanced intervention arm: Fitness classes + childcare + peer support

EXPERIMENTAL

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

Interventions

Comparator ArmBEHAVIORAL

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

Comparator Arm: Fitness classes + childcare
Enhanced intervention armBEHAVIORAL

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.

Enhanced intervention arm: Fitness classes + childcare + peer support

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMothers
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Total household income being greater than 165% of the area median income (calculated by household size).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Thomas Jefferson Recreation Center

New York, New York, 10029, United States

ACTIVE NOT RECRUITING

Highbridge Park

New York, New York, 10033, United States

RECRUITING

Jackie Robinson Recreation Center

New York, New York, 10039, United States

ACTIVE NOT RECRUITING

Williamsbridge Oval

New York, New York, 10467, United States

ACTIVE NOT RECRUITING

St. James Recreation

New York, New York, 10468, United States

RECRUITING

Hunts Point Recreation Center

New York, New York, 10474, United States

RECRUITING

St. John's Park Recreation Center

New York, New York, 11213, United States

ACTIVE NOT RECRUITING

PS 003

New York, New York, 11216, United States

ACTIVE NOT RECRUITING

McCarren Play Center

New York, New York, 11222, United States

ACTIVE NOT RECRUITING

PS19

New York, New York, 11368, United States

ACTIVE NOT RECRUITING

Related Publications (1)

  • Watterson J, Magsamen-Conrad K, Gokal K, Oakley-Girvan I, Hirsch JS, Qian M, Buchsbaum R, Niles C, Van Horn K, Moshier S, Martinez A, Garcia Flores A, Laine S, Vega M, Houghton LC. 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. JMIR Res Protoc. 2026 Jan 13;15:e71381. doi: 10.2196/71381.

    PMID: 41529256DERIVED

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Lauren C Houghton, PhD

CONTACT

2123420246lh2746@cumc.columbia.edu

Sherece Laine, MPH

CONTACT

9175747512ssl2200@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The FT4W program is founded on social cognitive theory, which posits that human behavior is the product of the dynamic interplay of personal, behavioral, and environmental influences. Social cognitive theory emphasizes reciprocal determinism in interactions between people and their environments. The majority of physical activity interventions use social cognitive theory as indicated by the theory and technique tool developed by the Human Behavior Change Project. The study team also used the theory and technique tool to align the FT4W program components and mediating pathways with behavior change techniques and mechanisms of action substantiated in behavior change literature and expert consensus. For our study, the study team will measure social influence via social cohesion.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Epidemiology

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 23, 2024

Study Start

November 15, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(10)