Free Time For Wellness
NCT Number: NCT06474715
Acronym: FT4W
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physical Inactivity
Interventions: BEHAVIORAL: Arms
Sponsor: Columbia University
Collaborators: Monash University|Loughborough University|University of Iowa|Public Health Institute|Jovie USA, LLC|West Side Campaign Against Hunger|New York City Parks and Recreation|National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 720
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-30
Completion Date: 2026-12-31
Locations: NYC Parks, New York, New York, 11421, United States

Summary:
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.

Primary Outcome Measures: Total minutes of time spent in Moderate to Vigorous Physical Activity (MVPA), Weekly MVPA, total physical activity, sedentary time, and sleep will be objectively assessed using a blinded research-grade wrist-worn accelerometer (Axivity AX3) in all groups., Baseline and follow-up between weeks 10-12
Secondary Outcome Measures: EQ5D-5L score, The EQ5D-5L standardized survey is a generic measure of health status that includes five dimensions: mobility, self-care, usual activities, pain, and anxiety/depression. The EQ-5D-5L index is measured on a total scale from 0 to 1, whereby 0 indicates death and 1 perfect health., At baseline and follow-up between weeks 10-12|ICEpop CAPability measure for Adults (ICECAP-A) score, The ICECAP-A standardized survey captures the broader concept of well-being via five dimensions: feeling settled and secure; love, friendship, and support; being independent; achievement and progress; and enjoyment and pleasure. The ICECAP-A also generates a score between 0 to 1 where one equals 'full capability' and zero equals 'completely incapable'., At baseline and follow-up between weeks 10-12|Attendance, Shape Up NYC takes attendance at each fitness class, and community champions will take attendance at the peer support activities to understand participation, retention, and attrition levels.

Attendance rate of all fitness classes will be presented as the mean percent of attendance (\[# of participants present in class\] divided by \[# of available slots\] multiplied by 100) over 12 weeks., 12 weeks|Generalized Anxiety Disorder 2-item (GAD-2) score, The GAD-2 is a brief questionnaire that assesses patient anxiety. The total score range is 0-6, with a higher score indicating worse anxiety., Baseline and follow-up between weeks 10-12|Patient Health Questionnaire-2 (PHQ-2), PHQ-2 is a brief questionnaire that assesses frequency of depressed mood and anhedonia. The total score range is 0-6, with a higher score indicating worsening feelings of depression., Baseline and follow-up between weeks 10-12|International Physical Activity Questionnaire (IPAQ) score, Self-reported physical activity data will be collected using IPAQ. IPAQ asks participants to report the types and frequency of physical activities they have participated in over 7 days. IPAQ score is expressed as median(MET)-min per week: \[MET level\] x \[minutes of activity/day\] x \[days per week\]. It is scored as follows:

High: Any one of the following two criteria:

Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week OR 7+ days of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week

Moderate: Any one of the following three criteria:

3+ days of vigorous activity, at least 20 minutes per day OR 5+ days of moderate-intensity activity or walking of at least 30 minutes per day OR 5+ days of walking, moderate-intensity or vigorous intensity activities achieving a minimum of 600 MET-min/week.

Low: Individuals who do not meet criteria for either category, Baseline and follow-up between weeks 10-12