Wellness Program for Sedentary Lifestyle

(FT4W Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help low-income mothers become more physically active by testing a program called Free Time for Wellness. The program includes free fitness classes, with some participants also receiving childcare and peer support. It addresses barriers that prevent many mothers from being active, such as lack of time and resources. Mothers with children under 12, who speak English or Spanish, own a mobile phone, and live near certain NYC areas might be suitable for this trial. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative solutions for overcoming barriers to physical activity.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Free Time for Wellness program is safe?

Research has shown that fitness classes, with or without additional support like childcare and group activities, are generally safe for participants. Studies on exercise indicate that regular physical activity can improve health and lower the risk of chronic diseases. No reports of serious problems related to these programs have emerged.

In the enhanced program, participants receive both fitness classes and additional support, such as childcare and group activities, designed to make staying active easier. While specific safety data for this program isn't provided, the activities involved are generally considered safe and beneficial.

Overall, joining fitness classes with added benefits like childcare and group support is expected to be well-received, helping people become more active without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wellness Program for Sedentary Lifestyle because it offers a holistic approach to increasing physical activity. Unlike traditional fitness programs that only offer exercise classes, this program provides additional support such as childcare and peer activities, making it easier for participants to attend classes and stay motivated. The enhanced intervention arm even includes community-building activities and peer support, which can foster a sense of belonging and increase long-term engagement. This comprehensive support system is a fresh take on promoting an active lifestyle and could make it more accessible and sustainable for participants.

What evidence suggests that this trial's treatments could be effective for increasing physical activity among low-resourced mothers?

Research has shown that adding peer support and childcare to fitness classes can help mothers become more active. In this trial, participants in the enhanced intervention arm will receive fitness classes along with childcare and peer support. Studies have found that this combination makes it easier for mothers to exercise by removing common obstacles like lack of time and childcare duties. Participants in programs with peer support often feel more motivated and committed. This approach can lead to more moderate-to-vigorous physical activity, which is linked to better health. Overall, combining fitness classes with childcare and peer support appears promising for increasing physical activity levels. ^{5 6 7 8 9}

Who Is on the Research Team?

Lauren C Houghton, PhD, MSc

Principal Investigator

Dept of Epidemiology, MSPH

Are You a Good Fit for This Trial?

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

Own a mobile phone

Live in the zip code surrounding Shape Up NYC sites

I have children under 12 years old.

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11579959/

Associations Between Childcare Physical Activity and ... The aim of this study was to examine the association between preschool children's physical activity and sedentary time during childcare and various ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12013060/

Associations of different types of physical activity and ... Context matters: examining perceived health and fitness outcomes of physical activity participation among South Korean Adults and Youth.

3. researchgate.net researchgate.net/publication/390410822_A_Systematic_Review_of_Physical_Activity_Sedentary_Behavior_and_Screen_Time_in_Youth_Aged_7-18

(PDF) A Systematic Review of Physical Activity, Sedentary ... To systematically review the existing literature on the trends of physical activity and sedentary behavior in children and adolescents, and their impact on non ...

4. cdc.gov cdc.gov/pcd/issues/2023/22_0325.htm

Effect of Applying Best Practices for Physical Activity and ... For every physical activity practice met by caregivers, the percentage of children's MVPA time increased by 0.8%, and the percentage of their ...

5. withpower.com withpower.com/trial/phase-physical-inactivity-10-2024-84a63

Free Time for Wellness Program for Sedentary Lifestyle Participants are randomized into one of three arms: fitness classes only, fitness classes with childcare, or fitness classes with childcare and peer support.

6. activehealthykids.org activehealthykids.org/wp-content/uploads/2022/11/US-report-card-short-form-2022.pdf

The 2022 United States Report Card on Physical Activity The primary goal of the 2022 U.S. Report Card is to assess the levels of physical activity and sedentary behaviors in American children and youth,.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7691077/

2020 WHO guidelines on physical activity and sedentary ... In children and adolescents, higher amounts of sedentary behaviour are associated with the following poor health outcomes: increased adiposity; ...

8. who.int who.int/news-room/fact-sheets/detail/physical-activity

Physical activity People who are insufficiently active have a 20% to 30% increased risk of death compared to people who are sufficiently active. Regular physical ...

9. cdc.gov cdc.gov/healthy-schools/health-academics/sedentary-grades.html

Physical Activity and Sedentary Behaviors and Academic ... These YRBS results show evidence of a significant association between physical activity or sedentary behaviors and academic grades.