Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05528380
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-29
First Post:
2022-07-19
Brief Title:
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
Sponsor:
Butler Hospital
Organization:
Butler Hospital
Study Overview
Official Title:
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program The primary outcomes will be self reported percent days of cannabis use and physical activity Secondary outcomes include self -reported measures of depression and anxiety symptoms adaptive coping and self-efficacy for cannabis abstinence
Detailed Description:
This study will recruit 20 women in an open trial who are high risk for prenatal cannabis use for a 12-week program of using a Fitbit activity tracker and receiving a Lifestyle Physical Activity program The primary outcomes will be self reported percent days of cannabis use and physical activity Secondary outcomes include self -reported measures of depression and anxiety symptoms adaptive coping and self-efficacy for cannabis abstinence The investigators will clinically monitor all participants in the study for safety and clinical deterioration and measure a variety of symptom outcomes over the course of the intervention period during pregnancy as well as at a postpartum follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None