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Behavioral Intervention
Physical Activity and Fitbit for Reducing Cannabis Use During Pregnancy
N/A
Recruiting
Led By Cynthia Battle, PhD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12-week endpoint
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to create and test a program to help pregnant women reduce their cannabis use.
Who is the study for?
This trial is for pregnant women over 18, between 12-25 weeks along with a healthy pregnancy, who use cannabis weekly and want to stop. They must be cleared for exercise by their doctor, not meet current physical activity guidelines, experience some psychological distress, speak English, own a smartphone for the Fitbit app, and have an interest in reducing cannabis use.
What is being tested?
The study is testing two approaches to help reduce cannabis use during pregnancy: one group will receive a lifestyle physical activity (LPA) program plus a Fitbit device; another group will get only the Fitbit. The goal is to see if adding LPA helps more than just tracking steps.
What are the potential side effects?
There are no direct side effects from the interventions being tested since they involve physical activity and using a Fitbit. However, participants should follow medical advice regarding safe exercise levels during pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12-week endpoint
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12-week endpoint
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Activity Minutes/Day
International Physical Activity Questionnaire
Steps/day
+8 moreSecondary study objectives
Brief COPE
Edinburgh Postnatal Depression Screen
Generalized Anxiety Disorder -7
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LPA and FitbitExperimental Treatment1 Intervention
The 12-week LPA+Fitbit intervention consists of 3 components:
1. In-Person LPA+Fitbit Orientation
2. Telephone PA counseling sessions.
3. Fitbit activity tracker.
Group II: Only FitbitActive Control1 Intervention
The Fitbit Only condition will include 3 components:
1. In-person Fitbit Orientation.
2. Fitbit Activity Tracker.
3. Brief Telephone Check-ins.
Find a Location
Who is running the clinical trial?
Butler HospitalLead Sponsor
131 Previous Clinical Trials
16,458 Total Patients Enrolled
Cynthia Battle, PhDPrincipal InvestigatorButler Hospital
2 Previous Clinical Trials
330 Total Patients Enrolled