Free Time For Wellness Pilot Effectiveness Trial

Browse trials for

• Sedentary Behavior 332

Keywords

• Motherhood
• Childcare
• Social cohesion

Sedentary Behavior

332 studies on the registry are indexed under Sedentary Behavior; 155 are open to participants now.

This study's enrollment of 89 is above the median of 70 across 287 interventional studies indexed under Sedentary Behavior.

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Study arms

• No intervention
  Control Arm: Fitness classes only

  There will be 3 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.

• Active comparator
  Comparator Arm: Fitness classes + childcare

  There will be 3 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. In addition, they will receive childcare in an adjacent space to the fitness class. Weekly reminders for each class will be sent via automated text messages to individuals.

  Behavioral: Arms

• Experimental
  Enhanced intervention arm: Fitness classes + childcare + peer support

  There will be 3 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. In addition, they will receive childcare in an adjacent space to the fitness class. In addition to childcare, Arm C will also receive peer support activities. Peer support activities will consist of group volunteer activities at food pantries, free deliveries of food pantry groceries, and group play dates at local playgrounds. A Community Champion will also facilitate group text messages.

  Behavioral: Arms

Interventions

• BehavioralArms

  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)

   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.

   Time frame: Baseline and follow-up between weeks 10-12

Secondary outcomes

1. 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.

   Time frame: At baseline and follow-up between weeks 10-12

2. 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'.

   Time frame: At baseline and follow-up between weeks 10-12

3. 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.

   Time frame: 12 weeks

4. 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.

   Time frame: Baseline and follow-up between weeks 10-12

5. 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.

   Time frame: Baseline and follow-up between weeks 10-12

6. 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

   Time frame: Baseline and follow-up between weeks 10-12

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Oct 10, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Based on ethical considerations, only the quantitative aggregated data produced in the course of the project will be preserved and shared. The final dataset will include self-reported demographic and behavioral data from surveys and accelerometer data aggregated at the cluster level. To facilitate interpretation of the data, a data dictionary and copies of blank questionnaires will be created, shared, and associated with the relevant datasets.