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Completed

NCT Number: NCT06474715

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

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Key information

Conditions

Physical Inactivity Behavior Sedentary Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Astoria Park, Astoria, New York, United States

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About this study

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 pilot test the 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. The study team will recruit 90 participants into 3 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Arms

Behavioral

The intervention includes a task-based interaction (volunteer activities) where cognitive demand is low and interactional roles are clear. The focus is on the task, rather than developing relationships, reducing the pressure of interaction. As the volunteer activities continue, they also offer the opportunity for group members to enhance empathy, another salient component of cross-group relational development. Mediated interaction supports new relational development through a disinhibiting effect, lowering inhibitions and increasing comfort and disclosure

Primary outcomes

  1. Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA)

    Time frame: 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 outcomes

  1. EQ5D-5L Score

    Time frame: 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.

  2. ICEpop CAPability Measure for Adults (ICECAP-A) Score

    Time frame: 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'.

  3. Attendance

    Time frame: 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.

  4. Generalized Anxiety Disorder 2-item (GAD-2) Score

    Time frame: 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.

  5. Patient Health Questionnaire-2 (PHQ-2)

    Time frame: 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.

  6. International Physical Activity Questionnaire (IPAQ) Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Jovie USA, LLC
  • Loughborough University
  • Monash University
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • New York City Parks and Recreation
  • Public Health Institute
  • University of Iowa
  • West Side Campaign Against Hunger

Registry information

Official study title

Cluster Randomized Controlled Trial to Promote Physical Activity Among Low-resourced Mothers in New York City: Protocol for the Free Time for Wellness (FT4W) Effectiveness Trial.

Acronym: FT4W

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 26, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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