Physical InactivityFT4WNCT06474715
Free Time For Wellness Pilot Effectiveness Trial
A study testing Arms in people with Physical Inactivity, run by Columbia University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Arms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 May 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Total household income being greater than 165% of the area median income (calculated by household size).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Astoria Park
Astoria, New York, 11105
Crocheron Park
Bayside, New York, 11361
Forest Park
Richmond Hill, New York, 11418
About this study
Official 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.
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.
Read the 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 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.
- Conditions
- Physical Inactivity
- Being tested
- Arms
- Keywords
- Motherhood, Childcare, Social cohesion
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Fitness classes only | No intervention | 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. |
| Comparator Arm: Fitness classes + childcare | Active comparator | 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. Receives: Behavioral: Arms |
| Enhanced intervention arm: Fitness classes + childcare + peer support | Experimental | 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. Receives: Behavioral: Arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and follow-up between weeks 10-12
Secondary outcomes (6)
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.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and follow-up between weeks 10-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start30 May 2024
- Primary completion14 Oct 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The FT4W program is founded on social cognitive theory, which posits that human behavior is the product of the dynamic interplay of personal, behavioral, and environmental influences. Social cognitive theory emphasizes reciprocal determinism in interactions between people and their environments. The majority of physical activity interventions use social cognitive theory as indicated by the theory and technique tool developed by the Human Behavior Change Project. The study team also used the theory and technique tool to align the FT4W program components and mediating pathways with behavior change techniques and mechanisms of action substantiated in behavior change literature and expert consensus. For our study, the study team will measure social influence via social cohesion.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Principal investigator, Lauren C. Houghton, Columbia University
- Investigators
- Lauren C Houghton, PhD, MSc, Principal investigator, Dept of Epidemiology, MSPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474715
- Sponsor's protocol ID
- AAAU8303 - Pilot
- Other IDs
- 5R01MD018609
- Acronym
- FT4W
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2024
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06474715
- Acronym / sponsor ID
- FT4W / AAAU8303 - Pilot
- Conditions
- Physical Inactivity
- Keywords
- Motherhood, Childcare, Social cohesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- 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)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The FT4W program is founded on social cognitive theory, which posits that human behavior is the product of the dynamic interplay of personal, behavioral, and environmental influences. Social cognitive theory emphasizes reciprocal determinism in interactions between people and their environments. The majority of physical activity interventions use social cognitive theory as indicated by the theory and technique tool developed by the Human Behavior Change Project. The study team also used the theory and technique tool to align the FT4W program components and mediating pathways with behavior change techniques and mechanisms of action substantiated in behavior change literature and expert consensus. For our study, the study team will measure social influence via social cohesion.
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Fitness classes only | No intervention | –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. |
| Comparator Arm: Fitness classes + childcare | Active comparator | Behavioral: ArmsThere 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. |
| Enhanced intervention arm: Fitness classes + childcare + peer support | Experimental | Behavioral: ArmsThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Total household income being greater than 165% of the area median income (calculated by household size).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArmsThe 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 | Behavioural | Comparator Arm: Fitness classes + childcare, Enhanced intervention arm: Fitness classes + childcare + peer support |
Primary outcome
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.
6 secondary outcomes
EQ5D-5L Score
Time frame: At baseline and follow-up between weeks 10-12
ICEpop CAPability Measure for Adults (ICECAP-A) Score
Time frame: At baseline and follow-up between weeks 10-12
Attendance
Time frame: 12 weeks
Generalized Anxiety Disorder 2-item (GAD-2) Score
Time frame: Baseline and follow-up between weeks 10-12
Patient Health Questionnaire-2 (PHQ-2)
Time frame: Baseline and follow-up between weeks 10-12
International Physical Activity Questionnaire (IPAQ) Score
Time frame: Baseline and follow-up between weeks 10-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
Related trials for Physical Inactivity
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Promoting Physical Activity in Older Hispanic/Latino(a) Adults
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Individual Variability in Energy Compensation After a 12-Week Supervised Exercise Intervention
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Effects of Different Amounts of Plyometric Exercise Without Jumping in Physically Inactive Older Adults
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E-Bike Commuting and Health in Overweight College Students
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren C Houghton, PhD, MSc principal investigator
Dept of Epidemiology, MSPH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arms in people with Physical Inactivity, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) (time frame: Baseline and follow-up between weeks 10-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.