What side effects are associated with this type of intervention?

Behavioral interventions, such as the Lifestyle Physical Activity Program, aim to reduce cannabis use and improve physical activity during pregnancy. These interventions typically involve motivational enhancement therapy and cognitive-behavioral therapy (CBT). Known side effects of these behavioral treatments are minimal, primarily including potential temporary increases in anxiety or stress as individuals adjust to new routines and coping strategies. Medications like varenicline and gabapentin, which are sometimes used to treat cannabis use disorder, can have side effects such as dizziness, nausea, headaches, and mood changes. It is important for pregnant individuals to consult with their healthcare provider to determine the safest and most effective treatment plan.

What prior FDA approvals exist?

The FDA has not specifically approved any treatments that directly align with the Lifestyle Physical Activity Program aimed at reducing cannabis use and improving physical activity during pregnancy. However, behavioral interventions, including lifestyle modifications and physical activity programs, are commonly recommended to improve maternal and fetal health outcomes. These interventions focus on promoting healthy behaviors, reducing substance use, and increasing physical activity, which are crucial for managing health during pregnancy.

What other types of research exist?

Promising alternatives to the Lifestyle Physical Activity Program for pregnant patients include: 1) Mobile health interventions like Text4baby, which deliver health-related text messages to improve physical activity; 2) Tailored exercise interventions such as the one used in the Behaviors Affecting Baby and You (BABY) Study, which showed positive outcomes in physical activity among pregnant women; 3) Internet-based interventions and smartphone apps for behavior modification, which have been effective in smoking cessation and could be adapted for cannabis use reduction and physical activity improvement.

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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)

Must not have

Cognitive impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12-week endpoint

Awards & highlights

No Placebo-Only Group

Summary

This trial will involve 20 pregnant women at high risk for cannabis use. They will use a Fitbit to track their physical activity and follow a program to increase their daily exercise. The goal is to help them reduce cannabis use and improve their mental health during 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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have difficulty with memory or thinking clearly.

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

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 more

Secondary study objectives

Brief COPE

Edinburgh Postnatal Depression Screen

Generalized Anxiety Disorder -7

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral interventions during pregnancy, such as the Lifestyle Physical Activity Program, work by encouraging healthier lifestyle choices through education, motivation, and support. These interventions typically involve personalized counseling, goal setting, and tracking tools to monitor progress. This approach is important for pregnant patients as it helps reduce the risks associated with cannabis use and sedentary behavior, ultimately improving maternal and fetal health outcomes.

Interventions to improve physical activity during pregnancy: a systematic review on issues of internal and external validity using the RE-AIM framework.Impact of an exercise intervention on physical activity during pregnancy: the behaviors affecting baby and you study.Epidemiological studies in Poland on effect of physical activity of pregnant women on the health of offspring and future generations - adaptation of the hypothesis development origin of health and diseases.