Free Time For Wellness 2+
- Conditions
- Physical Inactivity
- Registration Number
- NCT06654843
- Lead Sponsor
- Columbia University
- Brief 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.
- Detailed Description
Physical inactivity is particularly prevalent in women of low socioeconomic position (SEP) (60% are inactive), suggesting that there are structural barriers to being physically active. This study will test the effectiveness of an intervention to increase physical activity among mothers of low SEP, where there is high risk of chronic disease and significant potential to make an impact on these health disparities.
This study comprises a 3-arm parallel cluster randomized controlled trial with low-resourced mothers living in New York City. The study team will randomize fitness class sites (clusters) into Arm A (contact control), receipt of free weekly fitness classes; Arm B, receipt of free childcare combined with free weekly fitness classes; and Arm C, receipt of free childcare combined with free weekly fitness classes and, plus peer support activities. Over two years the study team will recruit eight waves totaling 630 participants into 21 fitness classes. Physical activity is the primary outcome measured using accelerometers, a self-reported questionnaire, and attendance data. Secondary outcomes (e.g., health status) and mediators/moderators (e.g., social support and cohesion) will be assessed with a baseline and follow-up questionnaire. Ethnographic methods will be used to examine how intersecting forms of social inequality shape women's experiences of physical activity and to understand how real-world conditions shape the intervention implementation. The intention-to-treat analysis will employ linear mixed-effects models (LMM) to assess the main intervention effects on physical activity outcomes and other secondary outcomes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 630
- Understand/speak English or Spanish, Have children <12 years old, Own a mobile phone, Live in the zip code surrounding as Shape Up NYC sites
- Total household income being greater than 165% of the area median income (calculated by household size).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Total minutes of time spent in Moderate to Vigorous Physical Activity (MVPA) Baseline and follow-up between weeks 10-12 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.
- Secondary Outcome Measures
Name Time Method EQ5D-5L score At baseline and follow-up between weeks 10-12 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.
ICEpop CAPability measure for Adults (ICECAP-A) score At baseline and follow-up between weeks 10-12 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'.
Attendance 12 weeks 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.Generalized Anxiety Disorder 2-item (GAD-2) score Baseline and follow-up between weeks 10-12 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.
Patient Health Questionnaire-2 (PHQ-2) Baseline and follow-up between weeks 10-12 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.
International Physical Activity Questionnaire (IPAQ) score Baseline and follow-up between weeks 10-12 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
Trial Locations
- Locations (3)
Thomas Jefferson Recreation Center
🇺🇸New York, New York, United States
Highbridge Park
🇺🇸New York, New York, United States
Jackie Robinson Recreation Center
🇺🇸New York, New York, United States