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LPA + Fitbit Intervention for Reducing Cannabis Use During Pregnancy

N/A
Waitlist Available
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
12-22 weeks gestation with a healthy singleton pregnancy
Elevated depression (EPDS>=7) or anxiety (GAD7>=5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12-week endpoint
Awards & highlights

Study Summary

This trial will test an exercise and Fitbit intervention to reduce cannabis use in pregnant women, and measure symptom outcomes during and after pregnancy.

Who is the study for?
This trial is for pregnant women over 18, between 12-22 weeks into a healthy pregnancy, who use cannabis at least once a week but want to reduce or stop during pregnancy. They should be cleared for moderate exercise, not meet current physical activity health recommendations, and have some symptoms of depression or anxiety.Check my eligibility
What is being tested?
The study tests if adding lifestyle physical activities (LPA) to Fitbit tracking helps reduce prenatal cannabis use compared to just using a Fitbit. Women will either get the LPA+Fitbit intervention or only the Fitbit for 12 weeks and will be monitored throughout their pregnancy and postpartum.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medications, side effects may include typical exercise-related issues such as muscle soreness or strain. Clinical monitoring aims to ensure safety and prevent any serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 12-22 weeks pregnant with one healthy baby.
Select...
I have been feeling more depressed or anxious lately.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12-week endpoint
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12-week endpoint for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Activity Minutes/Day
International Physical Activity Questionnaire
Steps/day
+8 more
Secondary outcome measures
Brief COPE
Edinburgh Postnatal Depression Screen
Generalized Anxiety Disorder -7
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open Trial InterventionExperimental Treatment1 Intervention
Participants will receive a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor
129 Previous Clinical Trials
16,377 Total Patients Enrolled

Media Library

Pregnancy Research Study Groups: Open Trial Intervention
~4 spots leftby May 2025
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