Physical Inactivity
Conditions
Keywords
Motherhood, Childcare, Social cohesion
Brief 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 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.
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
Sponsors
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)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
\- Total household income being greater than 165% of the area median income (calculated by household size).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICEpop CAPability Measure for Adults (ICECAP-A) Score | At baseline and follow-up between weeks 10-12 | 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'. |
| Attendance | 12 weeks | 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. |
| EQ5D-5L Score | At baseline and follow-up between weeks 10-12 | 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. |
| Patient Health Questionnaire-2 (PHQ-2) | Baseline and follow-up between weeks 10-12 | 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. |
| International Physical Activity Questionnaire (IPAQ) Score | Baseline and follow-up between weeks 10-12 | 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 |
| Generalized Anxiety Disorder 2-item (GAD-2) Score | Baseline and follow-up between weeks 10-12 | 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. |
Countries
United States
Participant flow
Pre-assignment details
89 participants consented but 9 did not complete the baseline assessment, so total 80 participants are counted as part of the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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. | 31 |
| 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. | 23 |
| Total | 80 |
Baseline characteristics
| Characteristic | Control Arm: Fitness Classes Only | Comparator Arm: Fitness Classes + Childcare | Enhanced Intervention Arm: Fitness Classes + Childcare + Peer Support | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 31 Participants | 23 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 20 Participants | 17 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 11 Participants | 5 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 10 Participants | 12 Participants | 28 Participants |
| Race (NIH/OMB) White | 12 Participants | 12 Participants | 6 Participants | 30 Participants |
| Region of Enrollment United States | 26 participants | 31 participants | 23 participants | 80 participants |
| Sex/Gender, Customized Female | 25 Participants | 31 Participants | 23 Participants | 79 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Unknown/Not reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 31 | 0 / 23 |
| other Total, other adverse events | 0 / 26 | 0 / 31 | 0 / 23 |
| serious Total, serious adverse events | 0 / 26 | 0 / 31 | 0 / 23 |
Outcome results
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.
Time frame: Baseline and follow-up between weeks 10-12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arm: Fitness Classes Only | Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 548 minutes of MVPA per week | Standard Error 100 |
| Control Arm: Fitness Classes Only | Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) | Follow-up | 737 minutes of MVPA per week | Standard Error 105 |
| Comparator Arm: Fitness Classes + Childcare | Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 512 minutes of MVPA per week | Standard Error 78.9 |
| Comparator Arm: Fitness Classes + Childcare | Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) | Follow-up | 479 minutes of MVPA per week | Standard Error 83.5 |
| Enhanced Intervention Arm: Fitness Classes + Childcare + Peer Support | Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) | Follow-up | 404 minutes of MVPA per week | Standard Error 125 |
| Enhanced Intervention Arm: Fitness Classes + Childcare + Peer Support | Total Minutes of Time Spent in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 354 minutes of MVPA per week | Standard Error 125 |
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.
Time frame: 12 weeks
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.
Time frame: At baseline and follow-up between weeks 10-12
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.
Time frame: 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'.
Time frame: At 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
Time frame: 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.
Time frame: Baseline and follow-up between weeks 10-12