Physical InactivityFT4W2+NCT06654843
Free Time For Wellness 2+
A study testing Comparator Arm and Enhanced intervention arm in people with Physical Inactivity, run by Columbia University at 10 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?
- Comparator Arm and Enhanced intervention arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 3 recruiting
- Active, not recruiting
Thomas Jefferson Recreation Center
New York, New York, 10029
- Recruiting
Highbridge Park
New York, New York, 10033
- Active, not recruiting
Jackie Robinson Recreation Center
New York, New York, 10039
- Active, not recruiting
Williamsbridge Oval
New York, New York, 10467
- Recruiting
St. James Recreation
New York, New York, 10468
- Recruiting
Hunts Point Recreation Center
New York, New York, 10474
- Active, not recruiting
St. John's Park Recreation Center
New York, New York, 11213
- Active, not recruiting
PS 003
New York, New York, 11216
- Active, not recruiting
McCarren Play Center
New York, New York, 11222
- Active, not recruiting
PS19
New York, New York, 11368
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 test the effectiveness of 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 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.
- Conditions
- Physical Inactivity
- Being tested
- Comparator Arm, Enhanced intervention arm
- Keywords
- motherhood, childcare, social cohesion, child, exercise, social networking, public health, community-based
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator ArmBehavioural
In addition to fitness classes, they will receive childcare in an adjacent space to the fitness class.
Enhanced intervention armBehavioural
In addition to fitness classes, 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: No Intervention: Control Arm: Fitness classes only | No intervention | There will be 21 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 21 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. Receives: Behavioral: Comparator Arm |
| Enhanced intervention arm: Fitness classes + childcare + peer support | Experimental | There will be 21 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. Receives: Behavioral: Enhanced intervention arm |
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 posted23 Oct 2024
- Study start15 Nov 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 630 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654843
- Sponsor's protocol ID
- AAAU8303 Wave 2+
- Other IDs
- 5R01MD018609
- Acronym
- FT4W2+
- Status last verified
- Nov 2025
- First submitted
- 21 Oct 2024
- Last updated
- 12 Nov 2025
- Results posted
- No
- 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.
Publications
Watterson J, Magsamen-Conrad K, Gokal K, Oakley-Girvan I, Hirsch JS, Qian M, Buchsbaum R, Niles C, Van Horn K, Moshier S, Martinez A, Garcia Flores A, Laine S, Vega M, Houghton LC. Cluster Randomized Controlled Trial to Promote Physical Activity Among Low-Resourced Mothers in New York City: Protocol for the Free Time for Wellness Effectiveness Trial. JMIR Res Protoc. 2026 Jan 13;15:e71381. doi: 10.2196/71381.
PubMed 41529256
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. 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
- NCT06654843
- Acronym / sponsor ID
- FT4W2+ / AAAU8303 Wave 2+
- Conditions
- Physical Inactivity
- Keywords
- motherhood, childcare, social cohesion, child, exercise, social networking, public health, community-based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 630 participants (estimated)
- 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
- 15 Nov 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
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 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.
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: No Intervention: Control Arm: Fitness classes only | No intervention | –There will be 21 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: Comparator ArmThere will be 21 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. |
| Enhanced intervention arm: Fitness classes + childcare + peer support | Experimental | Behavioral: Enhanced intervention armThere will be 21 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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 |
|---|---|---|
| Comparator ArmIn addition to fitness classes, they will receive childcare in an adjacent space to the fitness class. | Behavioural | Comparator Arm: Fitness classes + childcare |
| Enhanced intervention armIn addition to fitness classes, 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. | Behavioural | 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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Derived from this study: PubMed 41529256Watterson J, Magsamen-Conrad K, Gokal K, Oakley-Girvan I, Hirsch JS, Qian M, Buchsbaum R, Niles C, Van Horn K, Moshier S, Martinez A, Garcia Flores A, Laine S, Vega M, Houghton LC. Cluster Randomized Controlled Trial to Promote Physical Activity Among Low-Resourced Mothers in New York City: Protocol for the Free Time for Wellness Effectiveness Trial. JMIR Res Protoc. 2026 Jan 13;15:e71381. doi: 10.2196/71381.
- 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.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparator Arm and Enhanced intervention arm in people with Physical Inactivity, run by Columbia University at 10 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 1 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: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren C Houghton, PhD (2123420246, lh2746@cumc.columbia.edu), or a site near the patient. 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?
On the ClinicalTrials.gov record for NCT06654843, which also lists 1 linked publication.
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 12 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.