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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MD018609 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Monash University | OTHER |
| Loughborough University | OTHER |
| University of Iowa | OTHER |
| Public Health Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and follow-up between weeks 10-12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and follow-up between weeks 10-12 |
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Inclusion Criteria:
Exclusion Criteria:
- Total household income being greater than 165% of the area median income (calculated by household size).
Mothers
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| Name | Affiliation | Role |
|---|---|---|
| Lauren C Houghton, PhD, MSc | Dept of Epidemiology, MSPH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Astoria Park | Astoria | New York | 11105 | United States | ||
| Crocheron Park |
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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89 participants consented but 9 did not complete the baseline assessment, so total 80 participants are counted as part of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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, participants 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The outcome data are not available for 42 out of the 80 enrolled because participants either did not return their accelerometer or they did not adhere to the protocol of wearing the accelerometer for at least 4 out of the 8 days. 12 unique participants in the Control Arm, 18 unique participants in the Comparator Arm, and 8 unique participants in the Enhanced arm were analyzed for this outcome. | Posted | Least Squares Mean | Standard Error | minutes of MVPA per week | Baseline and follow-up between weeks 10-12 |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Houghton, PhD Msc | Columbia University Irving Medical Center | 212-342-0246 | lh2746@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2025 | Oct 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| UNKNOWN |
| Jovie USA, LLC | INDUSTRY |
| West Side Campaign Against Hunger | UNKNOWN |
| New York City Parks and Recreation | UNKNOWN |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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.
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|
| 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'. |
| 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. | 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. | 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. | 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 | Baseline and follow-up between weeks 10-12 |
| Bayside |
| New York |
| 11361 |
| United States |
| Forest Park | Richmond Hill | New York | 11418 | United States |
| 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. |
| BG002 | 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, participants 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | 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, participants 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. |
|
|
| Secondary | 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. | Some participants in each arm did not complete the survey at follow-up | Posted | Mean | Standard Error | score on a scale | At baseline and follow-up between weeks 10-12 |
|
|
|
| Secondary | 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'. | Some participants in each arm did not complete the survey at follow-up | Posted | Mean | Standard Error | score on a scale | At baseline and follow-up between weeks 10-12 |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | percent | 12 weeks |
|
|
|
| Secondary | 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. | Some participants in each arm did not complete the survey at follow-up | Posted | Mean | Standard Error | score on a scale | Baseline and follow-up between weeks 10-12 |
|
|
|
| Secondary | 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. | Some participants in each arm did not complete the survey at follow-up | Posted | Mean | Standard Error | score on a scale | Baseline and follow-up between weeks 10-12 |
|
|
|
| Secondary | 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 | Some participants in each arm did not report activity at baseline or follow-up | Posted | Mean | Standard Error | MET-min per week | Baseline and follow-up between weeks 10-12 |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | 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, participants 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. | 0 | 23 | 0 | 23 | 0 | 23 |
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