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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

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I am 12-22 weeks pregnant with one healthy baby.

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I have been feeling more depressed or anxious lately.

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor

129 Previous Clinical Trials

16,402 Total Patients Enrolled

Media Library

Pregnancy Research Study Groups: Open Trial Intervention

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolling in this medical experiment?

"Affirmative. According to information on clinicaltrials.gov, this medical research project which was first posted in the month of January 2022 is currently recruiting participants. 70 individuals are sought from 1 centre for the study with its most recent update occurring in May 2023."

Answered by AI

Is enrollment for this trial currently available?

"According to data hosted on clinicaltrials.gov, the trial is open for recruitment and was initially listed online on January 30th 2022. The study information has been edited as recently as May 1st 2023."

Answered by AI

What potential outcomes are being sought from this medical experiment?

"The primary efficacy measure of this trial is Timeline Follow-back (TLFB), which will be monitored from the beginning to 12 weeks. Secondary outcomes include Marijuana Self-Efficacy Questionnaire, Generalized Anxiety Disorder -7 and Edinburgh Postnatal Depression Screen; these three questionnaires evaluate various levels of self-efficacy, anxiety severity and depression intensity respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use

2022. "Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05528380.