Free Time For Wellness Pilot Effectiveness Trial

NCT06474715 | Completed Results

• 2 other identifiers: AAAU8303 - Pilot5R01MD018609
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 3

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.

Conditions

Physical Inactivity

Keywords

Motherhood; Childcare; Social cohesion

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

Study Arms (3)

Control Arm: Fitness classes only

NO INTERVENTION

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.

Comparator Arm: Fitness classes + childcare

ACTIVE COMPARATOR

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.

Behavioral: Arms

Enhanced intervention arm: Fitness classes + childcare + peer support

EXPERIMENTAL

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.

Behavioral: Arms

Interventions

Arms 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

Comparator Arm: Fitness classes + childcare; Enhanced intervention arm: Fitness classes + childcare + peer support

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (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).

Sponsors & Collaborators

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

Study Sites (3)

Astoria Park

Astoria, New York, 11105, United States

Location

Crocheron Park

Bayside, New York, 11361, United States

Location

Forest Park

Richmond Hill, New York, 11418, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Lauren Houghton, PhD Msc
• Organization: Columbia University Irving Medical Center

lh2746@cumc.columbia.edu

212-342-0246

Study Officials

• Lauren C Houghton, PhD, MSc

  Dept of Epidemiology, MSPH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

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.

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: May 30, 2024
• Primary Completion: October 14, 2024
• Study Completion: April 1, 2025
• Last Updated: April 24, 2026
• Results First Posted: November 21, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)