Trial Outcomes & Findings for Free Time For Wellness Pilot Effectiveness Trial (NCT NCT06474715)
NCT ID: NCT06474715
Last Updated: 2025-11-21
Results Overview
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.
COMPLETED
NA
89 participants
Baseline and follow-up between weeks 10-12
2025-11-21
Participant Flow
89 participants consented but 9 did not complete the baseline assessment, so total 80 participants are counted as part of the study.
Unit of analysis: fitness class sites
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26 1
|
31 1
|
23 1
|
|
Overall Study
COMPLETED
|
12 1
|
18 1
|
8 1
|
|
Overall Study
NOT COMPLETED
|
14 0
|
13 0
|
15 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Free Time For Wellness Pilot Effectiveness Trial
Baseline characteristics by cohort
| Measure |
Control Arm: Fitness Classes Only
n=26 Participants
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
n=31 Participants
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.
|
Enhanced Intervention Arm: Fitness Classes + Childcare + Peer Support
n=23 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=68 Participants
|
31 Participants
n=76 Participants
|
23 Participants
n=48 Participants
|
80 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
|
Sex/Gender, Customized
Female
|
25 Participants
n=68 Participants
|
31 Participants
n=76 Participants
|
23 Participants
n=48 Participants
|
79 Participants
n=33 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
|
Sex/Gender, Customized
Unknown/Not reported
|
1 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=68 Participants
|
20 Participants
n=76 Participants
|
17 Participants
n=48 Participants
|
49 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=68 Participants
|
11 Participants
n=76 Participants
|
5 Participants
n=48 Participants
|
28 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
3 Participants
n=33 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
1 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
2 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=68 Participants
|
2 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
7 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=68 Participants
|
2 Participants
n=76 Participants
|
3 Participants
n=48 Participants
|
8 Participants
n=33 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=68 Participants
|
12 Participants
n=76 Participants
|
6 Participants
n=48 Participants
|
30 Participants
n=33 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
4 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
5 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=68 Participants
|
10 Participants
n=76 Participants
|
12 Participants
n=48 Participants
|
28 Participants
n=33 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=68 Participants
|
31 participants
n=76 Participants
|
23 participants
n=48 Participants
|
80 participants
n=33 Participants
|
PRIMARY outcome
Timeframe: Baseline and follow-up between weeks 10-12Population: 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.
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.
Outcome measures
| Measure |
Control Arm: Fitness Classes Only
n=12 Participants
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
n=18 Participants
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.
|
Enhanced Intervention Arm: Fitness Classes + Childcare + Peer Support
n=8 Participants
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.
|
|---|---|---|---|
|
Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA)
Follow-up
|
737 minutes of MVPA per week
Standard Error 105.0
|
479 minutes of MVPA per week
Standard Error 83.5
|
404 minutes of MVPA per week
Standard Error 125.0
|
|
Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA)
Baseline
|
548 minutes of MVPA per week
Standard Error 100.0
|
512 minutes of MVPA per week
Standard Error 78.9
|
354 minutes of MVPA per week
Standard Error 125.0
|
SECONDARY outcome
Timeframe: At baseline and follow-up between weeks 10-12The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and follow-up between weeks 10-12The 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'.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksShape 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and follow-up between weeks 10-12The GAD-2 is a brief questionnaire that assesses patient anxiety. The total score range is 0-6, with a higher score indicating worse anxiety.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and follow-up between weeks 10-12PHQ-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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and follow-up between weeks 10-12Self-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
Outcome measures
Outcome data not reported
Adverse Events
Control Arm: Fitness Classes Only
Comparator Arm: Fitness Classes + Childcare
Enhanced Intervention Arm: Fitness Classes + Childcare + Peer Support
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lauren Houghton, PhD Msc
Columbia University Irving Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place