Wellness Program for Sedentary Lifestyle

(FT4W Trial)

Recruiting at 3 trial locations

Overseen By Lauren Houghton, PhD Msc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: High income

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

89 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lauren C Houghton, PhD, MSc

Principal Investigator

Dept of Epidemiology, MSPH

Eligibility Criteria

This trial is for low-resourced mothers with children under 12 years old who own a mobile phone and live near Shape Up NYC sites. They must understand or speak English or Spanish. Women with household incomes greater than 165% of the area median income are not eligible.

Inclusion Criteria

I have children under 12 years old.

Own a mobile phone

Live in the zip code surrounding Shape Up NYC sites

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized into one of three arms: fitness classes only, fitness classes with childcare, or fitness classes with childcare and peer support activities. Each participant attends 12 weekly fitness classes.

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for physical activity and health outcomes using questionnaires and accelerometers.

2-4 weeks

Treatment Details

Interventions

• Free Time for Wellness

Trial Overview The 'Free Time For Wellness' program aims to increase physical activity among mothers facing structural and social barriers to active leisure time, which can lead to chronic diseases due to inactivity.

Participant Groups

Group I: Enhanced intervention arm: Fitness classes + childcare + peer support Experimental Treatment 1 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. 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 II: Control Arm: Fitness classes only Active Control 1 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.

Group III: Comparator Arm: Fitness classes + childcare Active Control 1 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. 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Loughborough University

Collaborator

Trials

95

Recruited

35,000+

Public Health Institute

Collaborator

Trials

2

Recruited

720+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Jovie USA, LLC

Industry Sponsor

Trials

3

Recruited

1,100+

West Side Campaign Against Hunger

Collaborator

Trials

2

Recruited

720+

New York City Parks and Recreation

Collaborator

Trials

2

Recruited

720+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Monash University

Collaborator

Trials

204

Recruited

10,570,000+