Free Time For Wellness 2+ (FT4W2+)

Columbia University

Status: Enrolling

Conditions: Physical Inactivity

Treatments: Behavioral: Enhanced intervention arm; Behavioral: Comparator Arm

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06654843

AAAU8303 Wave 2+

5R01MD018609 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 630 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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630 participants in 3 patient groups

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

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Comparator Arm

Enhanced intervention arm: Fitness classes + childcare + peer support

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced intervention arm