Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654843
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Free Time for Wellness 2
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FT4W2
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 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 eg health status and mediatorsmoderators eg 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 womens 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
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 eg health status and mediatorsmoderators eg 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 womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None