Free Time For Wellness Pilot Effectiveness Trial

NCT ID: NCT06474715

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2025-04-01

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 pilot test the Free Time for Wellness (FT4W), an innovative multilevel physical activity intervention to increase physical activity among low-resourced mothers.

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 pilot test the 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. The study team will recruit 90 participants into 3 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.

Conditions

Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Enhanced intervention arm: Fitness classes + childcare + peer support

There will be 3 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.

In addition, 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.

Group Type: EXPERIMENTAL

Arms

Intervention Type: BEHAVIORAL

The intervention includes a task-based interaction (volunteer activities) where cognitive demand is low and interactional roles are clear. The focus is on the task, rather than developing relationships, reducing the pressure of interaction. As the volunteer activities continue, they also offer the opportunity for group members to enhance empathy, another salient component of cross-group relational development. Mediated interaction supports new relational development through a disinhibiting effect, lowering inhibitions and increasing comfort and disclosure

Control Arm: Fitness classes only

There will be 3 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Comparator Arm: Fitness classes + childcare

There will be 3 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.

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

Weekly reminders for each class will be sent via automated text messages to individuals.

Group Type: ACTIVE_COMPARATOR

Arms

Intervention Type: BEHAVIORAL

The intervention includes a task-based interaction (volunteer activities) where cognitive demand is low and interactional roles are clear. The focus is on the task, rather than developing relationships, reducing the pressure of interaction. As the volunteer activities continue, they also offer the opportunity for group members to enhance empathy, another salient component of cross-group relational development. Mediated interaction supports new relational development through a disinhibiting effect, lowering inhibitions and increasing comfort and disclosure

Interventions

Arms

The intervention includes a task-based interaction (volunteer activities) where cognitive demand is low and interactional roles are clear. The focus is on the task, rather than developing relationships, reducing the pressure of interaction. As the volunteer activities continue, they also offer the opportunity for group members to enhance empathy, another salient component of cross-group relational development. Mediated interaction supports new relational development through a disinhibiting effect, lowering inhibitions and increasing comfort and disclosure

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Monash University

OTHER

Sponsor Role: collaborator

Loughborough University

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

Public Health Institute

UNKNOWN

Sponsor Role: collaborator

Jovie USA, LLC

INDUSTRY

Sponsor Role: collaborator

West Side Campaign Against Hunger

UNKNOWN

Sponsor Role: collaborator

New York City Parks and Recreation

UNKNOWN

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Lauren C. Houghton

Assistant Professor of Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren C Houghton, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Dept of Epidemiology, MSPH

Locations

Astoria Park

Astoria, New York, United States

Crocheron Park

Bayside, New York, United States

Forest Park

Richmond Hill, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R01MD018609

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU8303 - Pilot

Identifier Type: -

Identifier Source: org_study_id