Clinical trial NCT06474715: Free Time For Wellness Pilot Effectiveness Trial
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Keywords: Motherhood
Childcare
Social cohesion
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Monash University
name: Loughborough University
name: University of Iowa
name: Public Health Institute
name: Jovie USA, LLC
name: West Side Campaign Against Hunger
name: New York City Parks and Recreation
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-06-26
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Total minutes of time spent in Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Baseline and follow-up between weeks 10-12
Secondary outcomes:
measure: EQ5D-5L score
timeFrame: At baseline and follow-up between weeks 10-12
measure: ICEpop CAPability measure for Adults (ICECAP-A) score
timeFrame: At baseline and follow-up between weeks 10-12
measure: Attendance
timeFrame: 12 weeks
measure: Generalized Anxiety Disorder 2-item (GAD-2) score
timeFrame: Baseline and follow-up between weeks 10-12
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Baseline and follow-up between weeks 10-12
measure: International Physical Activity Questionnaire (IPAQ) score
timeFrame: Baseline and follow-up between weeks 10-12
Other outcomes:
Locations:
city: Astoria
country: United States
facility: Astoria Park
state: New York
city: Bayside
country: United States
facility: Crocheron Park
state: New York
city: Richmond Hill
country: United States
facility: Forest Park
state: New York
Study officials:
affiliation: Dept of Epidemiology, MSPH
name: Lauren C Houghton, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: