Free Time for Wellness Program for Sedentary Lifestyle

(FT4W2+ Trial)

Recruiting at 2 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

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 test the effectiveness of Free Time for Wellness (FT4W), an innovative multilevel physical activity intervention to increase physical activity among low-resourced mothers.

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 data supports the effectiveness of the treatment Free Time for Wellness (FT4W) for sedentary lifestyle?

Research shows that interventions aimed at reducing sitting time, like the Free Time for Wellness program, can be effective. Strategies such as environmental changes and self-monitoring have been found promising in reducing sedentary behavior, which suggests that similar approaches in FT4W could help people become more active. ^{1 2 3 4 5}

What makes the Free Time for Wellness (FT4W) treatment unique for addressing a sedentary lifestyle?

The Free Time for Wellness (FT4W) treatment is unique because it focuses on reducing sedentary behavior by incorporating behavior change strategies like environmental restructuring and self-regulatory skills training, which have been shown to be promising in reducing sitting time. Unlike traditional exercise programs, FT4W targets the reduction of sedentary behavior itself, rather than just increasing physical activity. ^{4 6 7 8 9}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Qualitative comparative analysis of the implementation fidelity of a workplace sedentary reduction intervention. [2023]

2. United States 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. [2019]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness and Return-on-Investment of the Dynamic Work Intervention Compared With Usual Practice to Reduce Sedentary Behavior. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

The validity of the GENEActiv wrist-worn accelerometer for measuring adult sedentary time in free living. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Using mixed-method feasibility studies to examine the impact of a mobile standing desk on undergraduates' sedentary time. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

What is the metabolic and energy cost of sitting, standing and sit/stand transitions? [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity barriers and motivators among high-risk employees. [2017]