Free Time For Wellness 2+

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Physical Inactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Comparator Arm

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Enhanced intervention arm

Intervention Type BEHAVIORAL

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.

Interventions

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Comparator Arm

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Responsible Party

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Lauren C. Houghton

Assistant Professor of Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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