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Behavioral Intervention

LPA and Fitbit for 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

Study 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.Check my eligibility

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.See study design

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

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

2Treatment groups

Experimental Treatment

Active Control

Group I: LPA and FitbitExperimental Treatment1 Intervention

The 12-week LPA+Fitbit intervention consists of 3 components: In-Person LPA+Fitbit Orientation Telephone PA counseling sessions. Fitbit activity tracker.

Group II: Only FitbitActive Control1 Intervention

The Fitbit Only condition will include 3 components: In-person Fitbit Orientation. Fitbit Activity Tracker. Brief Telephone Check-ins.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor

129 Previous Clinical Trials

16,368 Total Patients Enrolled

Cynthia Battle, PhDPrincipal InvestigatorButler Hospital

2 Previous Clinical Trials

330 Total Patients Enrolled

Frequently Asked Questions

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

Is the current investigation open for participant enrollment?

"As per details on clinicaltrials.gov, this research endeavor is actively seeking suitable participants. The trial was originally uploaded on January 22nd, 2024, and the most recent revision was made on January 26th of the same year."

Answered by AI

How many patients are currently undergoing treatment in this clinical trial?

"Indeed, the details on clinicaltrials.gov imply that this investigation is actively seeking candidates. The trial became available on January 22nd, 2024 and was last modified on January 26th, 2024. Currently, they are aiming to enroll 50 participants at one designated location."

Answered by AI

What is the primary goal of this research endeavor?

"The main objective of this investigation is to assess The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2 over a span from Baseline to the end of the study at 12 weeks. Secondary endpoints comprise the Marijuana Self-Efficacy Questionnaire, which gauges self-reported efficacy for abstaining from cannabis with scores ranging between 0-100 indicating varying levels of strategies used for reducing marijuana consumption; Brief COPE, assessing coping strategies utilization through fourteen scales scoring between 2-8 denoting increased use of such mechanisms; and Edinburgh Postnatal Depression Screen measuring depression severity on a scale ranging from 0-30 where higher"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use - RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06239701.

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