Free Time for Wellness Program for Sedentary Lifestyle

(FT4W2+ Trial)

Recruiting at 9 trial locations

Overseen By Sherece Laine, MPH

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: 13

630 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help low-resourced mothers increase their physical activity levels. It will test a program called Free Time for Wellness (FT4W), which offers free fitness classes. Some participants will also receive childcare and peer support to facilitate class attendance. Participants will be divided into three groups: one with just fitness classes, one with classes and childcare, and one with classes, childcare, and peer support. Mothers who speak English or Spanish, have children under 12, own a mobile phone, and live near specific NYC sites are well-suited for this study. As an unphased trial, this study provides a unique opportunity for mothers to access free resources that can enhance their health and well-being.

Will I have to stop taking my current medications?

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 for participants?

Research has shown that programs like Free Time for Wellness (FT4W), which encourage increased physical activity, are generally safe and manageable. These programs aim to get people moving more and rarely cause harm. The FT4W program includes fitness classes, and past studies on similar activities have reported very few negative effects. Participants often report feeling more energetic and healthier.

Since FT4W is neither a medication nor a surgical treatment, the risks remain very low. The program aims to help participants find time for exercise by offering fitness classes, childcare, and peer support. These features are designed to be both safe and beneficial. For those considering joining the trial, the primary goal will be to increase physical activity in a supportive setting, which is unlikely to pose any major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Free Time for Wellness (FT4W) program as it offers a unique approach to combating sedentary lifestyles. Unlike standard fitness programs that often only provide exercise classes, FT4W combines fitness classes with additional supportive elements. The enhanced intervention arm of the program includes free childcare and peer support, which addresses common barriers to maintaining an active lifestyle, such as time constraints and lack of motivation. This holistic approach not only encourages regular physical activity but also builds a supportive community, potentially leading to more sustainable lifestyle changes. By incorporating these innovative features, the FT4W program aims to make fitness more accessible and effective for participants.

What evidence suggests that the Free Time for Wellness program could be effective for increasing physical activity among low-resourced mothers?

Research has shown that the Free Time for Wellness (FT4W) program can increase physical activity among mothers with limited resources. In this trial, participants in the enhanced intervention arm will receive fitness classes along with support such as childcare and peer support, making exercise more accessible. The comparator arm will offer fitness classes with childcare, while the control arm will provide fitness classes only. Early results suggest that these resources help mothers become more active, which is important for reducing the risk of long-term health problems. One study found that social support and easy access to fitness options greatly increased participation and activity levels. These elements are essential for helping participants reach recommended exercise goals. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for low-resourced mothers who lead a sedentary lifestyle and struggle to find time for physical activity due to structural and social barriers. Specific eligibility details are not provided, but typically participants would need to meet certain health conditions.

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 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. Each participant attends 12 weekly fitness classes.

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in physical activity and health status using questionnaires and accelerometers.

2-4 weeks

1 visit (in-person), 1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Free Time for Wellness (FT4W)

Trial Overview The study aims to compare two approaches: a standard program (Comparator Arm) versus an enhanced intervention (Enhanced Intervention Arm) designed to help increase physical activity among the participants.

How Is the Trial Designed?

Group I: Enhanced intervention arm: Fitness classes + childcare + peer support Experimental Treatment 1 Intervention

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 II: Control Arm: No Intervention: Control Arm: Fitness classes only Active Control 1 Intervention

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 III: Comparator Arm: Fitness classes + childcare Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

West Side Campaign Against Hunger

Collaborator

Trials

2

Recruited

720+

Monash University

Collaborator

Trials

204

Recruited

10,570,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Loughborough University

Collaborator

Trials

95

Recruited

35,000+

New York City Parks and Recreation

Collaborator

Trials

2

Recruited

720+

Public Health Institute

Collaborator

Trials

2

Recruited

720+

Jovie USA, LLC

Industry Sponsor

Trials

3

Recruited

1,100+

Published Research Related to This Trial

A review of 26 studies found that interventions aimed at reducing sedentary behavior in adults were categorized as very promising (39%), quite promising (21%), and non-promising (39%), with worksite-based interventions being the most common.

The most effective strategies included environmental restructuring and self-monitoring techniques, suggesting that future interventions should focus on modifying environments and enhancing self-regulatory skills to reduce sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. Gardner, B., Smith, L., Lorencatto, F., et al.[2023]

The 'Stand and Move at Work' intervention significantly reduced sedentary time, with higher performing worksites achieving an average reduction of 75.2 minutes per 8-hour workday compared to only 30.3 minutes at lower performing sites, based on a 12-month study involving 12 worksites.

Key factors for success included adherence to the intervention protocol, such as providing accessible walking routes and fostering a supportive work culture for breaks, along with the competence and willingness of delivery personnel, highlighting the importance of implementation fidelity in achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative comparative analysis of the implementation fidelity of a workplace sedentary reduction intervention. Leonard, KS., Mullane, SL., Golden, CA., et al.[2023]

The study measured the metabolic energy cost (MEC) of sitting, standing, and transitioning between the two in 50 healthy adults, revealing that standing increases energy expenditure by 0.07 kcal/min compared to sitting.

Transitioning from sitting to standing (and back) incurs a metabolic cost of 0.32 kcal/min, suggesting that while public health recommendations to reduce sitting are beneficial, the energy costs of these transitions are modest and consistent across different sexes and body compositions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the metabolic and energy cost of sitting, standing and sit/stand transitions? Júdice, PB., Hamilton, MT., Sardinha, LB., et al.[2018]

A study involving 24 high-risk workers in a wellness program identified key barriers to physical activity, including physical limitations, lack of motivation, and time constraints.

Family relationships and social support were found to be the strongest motivators for these workers, emphasizing the need for tailored interventions that address their specific challenges and leverage their support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity barriers and motivators among high-risk employees. Paguntalan, JC., Gregoski, M.[2017]

The wrist-worn GENEActiv accelerometer provides estimates of sedentary time that are comparable to the activPAL device, with an Intraclass Correlation Coefficient of 0.80, indicating strong validity in measuring sedentary behavior in free-living adults.

The GENEActiv showed a slight underestimation of sedentary time compared to activPAL, but it offers a convenient alternative for measuring sedentary behavior, making it suitable for population studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The validity of the GENEActiv wrist-worn accelerometer for measuring adult sedentary time in free living. Pavey, TG., Gomersall, SR., Clark, BK., et al.[2022]

The OPTIMISE Your Health trial is a randomized controlled trial involving 250 desk-based workers aged 35-65 with type 2 diabetes, designed to evaluate the effectiveness of a 6-month health coaching program combined with a sit-stand workstation and activity tracker to reduce sitting time and improve glycemic control.

The primary outcomes of the trial include changes in sitting time and glycosylated hemoglobin (HbA1c) levels, which will provide valuable insights into how reducing sedentary behavior can benefit individuals with type 2 diabetes in terms of both metabolic and cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sitting less and moving more for improved metabolic and brain health in type 2 diabetes: 'OPTIMISE your health' trial protocol. Brakenridge, CJ., Gardiner, PA., Grigg, RV., et al.[2022]

In a study of 83 desk-based workers, the use of specific strategies to reduce sitting time and promote activity was linked to positive changes in prolonged sitting and stepping behaviors.

Workplace support played a crucial role in enhancing these outcomes, indicating that having a supportive environment is key to successfully reducing sitting and increasing activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Do Workers Do to Reduce Their Sitting Time? The Relationships of Strategy Use and Workplace Support With Desk-Based Workers' Behavior Changes in a Workplace-Delivered Sitting-Reduction and Activity-Promoting Intervention. Brakenridge, CL., Healy, GN., Winkler, EAH., et al.[2019]

The Dynamic Work (DW) Intervention, aimed at reducing sitting time among office workers, showed no significant differences in overall sitting time or societal costs between the intervention and control groups, but it did lead to lower presenteeism costs in the intervention group.

The intervention has a high probability (90%) of being cost-effective from a societal perspective and an 86% chance of providing financial savings for employers, suggesting it could be a beneficial investment for workplace health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness and Return-on-Investment of the Dynamic Work Intervention Compared With Usual Practice to Reduce Sedentary Behavior. Ben, ÂJ., Jelsma, JGM., Renaud, LR., et al.[2021]

Mobile standing desks (MSD) significantly reduced sedentary time among undergraduates, with a notable reduction observed in both a one-week study (n=21) and a one-month study (n=28).

The effectiveness of MSD was confirmed through both objective measurements and self-reports, indicating that these desks can be a practical solution for decreasing sedentary behavior in students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using mixed-method feasibility studies to examine the impact of a mobile standing desk on undergraduates' sedentary time. Moulin, MS., Prapavessis, H., Tucker, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06654843

Study Details | NCT06654843 | Free Time For Wellness 2+ The broad objective of this study is to test the effectiveness of Free Time for Wellness (FT4W), an innovative multilevel physical activity intervention to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34620141/

Free Time For Wellness: a co-designed intervention utilizing ... We co-designed an intervention, with the ultimate goal of building social cohesion through social media to increase physical activity for low resourced mothers ...

3. ctv.veeva.com ctv.veeva.com/study/free-time-for-wellness2

Free Time For Wellness 2+ - ClinicalTrials.Veeva This study will test the effectiveness of an intervention to increase physical activity among mothers of low SEP, where there is high risk of ...

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

Free Time for Wellness Program for Sedentary Lifestyle The broad objective of this study is to test the effectiveness of Free Time for Wellness (FT4W), an innovative multilevel physical activity intervention to ...

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-11775-9

Free Time For Wellness: a co-designed intervention utilizing ... Over 50% of U.S. men and women are failing to reach the recommended guidelines of 150 min of moderate to vigorous physical activity each week [1] ...

6. ctv.veeva.com ctv.veeva.com/study/free-time-for-wellness

Free Time For Wellness Pilot Effectiveness Trial (FT4W) This study will pilot test the intervention to increase physical activity among mothers of low SEP, where there is high risk of chronic disease ...