LPA + Fitbit Intervention for Reducing Cannabis Use During Pregnancy

Overseen By Rita Rossi, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Butler Hospital

Disqualifiers: Substance use disorder, Illicit substances, Psychotic symptoms, Suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant women reduce or stop using cannabis through a Fitbit and a physical activity program (LPA+Fitbit intervention). Participants will track their physical activity and attend sessions to set goals, overcome challenges, and use exercise as a coping strategy. The trial also examines how these changes might affect feelings of depression and anxiety. Pregnant women who use cannabis weekly, experience depression or anxiety, and wish to reduce cannabis use might be suitable for this trial. Participants need a smartphone to use the Fitbit app. As an unphased trial, this study offers a unique opportunity for participants to explore new ways to enhance their well-being during pregnancy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have recently started new mental health or substance use treatment within the past 4 weeks, you may not be eligible to participate.

What prior data suggests that the Fitbit and LPA interventions are safe for pregnant women?

Research shows that using a Fitbit and joining a Lifestyle Physical Activity (LPA) program is generally safe. In similar studies, participants have used these methods to track and improve physical activity without major safety issues. This process involves wearing a Fitbit to count daily steps and engaging in short talks to encourage more activity. No reports of serious negative effects have emerged from using either the Fitbit or the LPA program. These tools primarily help individuals become more active, which is typically a safe and healthy change. Although this trial is labeled "Not Applicable" for its phase, indicating limited direct safety data, similar programs have been well-tolerated in other studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to reducing cannabis use during pregnancy by integrating lifestyle physical activity (LPA) with technology. Unlike traditional methods that may focus solely on counseling or medication, this intervention uses a Fitbit to track activity levels and includes personalized sessions to help participants incorporate physical activity into their daily routines. This method not only helps address barriers to physical activity but also encourages using exercise as a coping strategy, which could offer a more holistic and sustainable way to manage cannabis use during pregnancy. The Fitbit-only arm also provides insights into how simply monitoring activity might influence behavior change, giving researchers a comprehensive look at how technology can aid in health interventions.

What evidence suggests that this trial's treatments could be effective for reducing cannabis use during pregnancy?

Research has shown that combining everyday physical activity with Fitbit tracking might help reduce cannabis use during pregnancy. In this trial, participants in the LPA+Fitbit intervention arm will engage in regular physical activity supported by Fitbit tracking and receive lifestyle physical activity sessions. Studies have found that exercise can help pregnant women manage stress, potentially leading to less cannabis use. Early results suggest that adding regular physical activity to Fitbit tracking reduces cannabis use more effectively than using a Fitbit alone, which is the focus of the Fitbit Only arm. This method encourages women to stay active and offers support through brief, regular check-ins. While detailed results are still being gathered, this combination appears promising in promoting healthier habits during pregnancy. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am cleared by a doctor for moderate exercise.

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

I am a woman aged 18 or older.

Exclusion Criteria

Current or recent suicidality or homicidally

Use of illicit substances in the last 3 months (other than cannabis)

I have difficulty with memory or thinking clearly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a Fitbit and participate in a 6-session lifestyle physical activity intervention over 12 weeks

12 weeks

6 sessions (phone or video)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum follow-up

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fitbit Only
• LPA+Fitbit intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: RCT Intervention Experimental Treatment 1 Intervention

In the Open Trial all participants received 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.

Group II: Fitbit Only Active Control 1 Intervention

Participants randomly assigned to this are will receive a Fitbit to track activity levels and participate in 6 brief check-ins to assess any issues with the Fitbit device or app.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

Published Research Related to This Trial

The 'SmokeFree Baby' smartphone app was specifically designed to support pregnant women in quitting smoking, utilizing established frameworks like the Medical Research Council and Behaviour Change Wheel to ensure its effectiveness.

The app includes five core modules targeting different aspects of behavior change, such as identity transformation and stress management, and aims to optimize intervention components for better smoking cessation outcomes in pregnant smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of SmokeFree Baby: a smoking cessation smartphone app for pregnant smokers. Tombor, I., Shahab, L., Brown, J., et al.[2022]

The study involving 56 pregnant women tested a sedentary behavior reduction program that included wearable alerts and self-monitoring, showing it was acceptable and feasible for participants.

Despite the program's feasibility, there was no significant reduction in sedentary behavior compared to the control group, indicating that further improvements are needed to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of a Sedentary Behavior Reduction Program during Pregnancy: A Semi-Experimental Study. Kawajiri, M., Nakamura, Y., Yoshida, M., et al.[2020]

In a study of 2229 women and their infants, cannabis use during the pre/early pregnancy period was linked to lower average birth weights and a 2.0 times higher likelihood of infants being small for gestational age, even after adjusting for other factors.

Women who reported cannabis use were generally younger and more likely to use other substances like alcohol and tobacco, highlighting the need for targeted clinical messaging for women trying to conceive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between maternal cannabis use and birth outcomes: an observational study. Michalski, CA., Hung, RJ., Seeto, RA., et al.[2021]

In a study of 67 overweight and obese adults using the Fitbit One for 6 weeks, participants showed a significant increase in moderate- to vigorous-intensity physical activity (MVPA) by 4.3 minutes per week, indicating that self-monitoring can enhance physical activity levels.

The addition of SMS text prompts initially boosted physical activity, leading to an increase of 1,266 steps and 17.8 minutes of MVPA in the intervention group, but this effect diminished after one week, suggesting that while prompts can be effective, their impact may be short-lived.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Sensor/Device (Fitbit One) and SMS Text-Messaging Prompts to Increase Physical Activity in Overweight and Obese Adults: A Randomized Controlled Trial. Wang, JB., Cadmus-Bertram, LA., Natarajan, L., et al.[2022]

Among 585 women surveyed, cannabis use was reported by 12% before pregnancy and 3% during pregnancy, with smoking being the most common method of use (58% before pregnancy and 42% during).

The study highlights a decrease in the frequency of cannabis use during pregnancy, with most users consuming cannabis monthly or less, and emphasizes the need for further research on the health effects of different cannabis administration methods during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routes of cannabis administration among females in the year before and during pregnancy: Results from a pilot project. Young-Wolff, KC., Adams, SR., Wi, S., et al.[2021]

In a study of 1147 women in New Hampshire, 16.8% reported using cannabis before conception, 5.5% during pregnancy, and 6.6% after giving birth, highlighting a notable prevalence of cannabis use during critical maternal health periods.

The primary reasons for cannabis use were stress or anxiety relief before conception and after birth, while during pregnancy, it was mainly used for its antiemetic properties to alleviate nausea, suggesting a need for healthcare providers to screen for cannabis use and address the underlying reasons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's cannabis use before, during, and after pregnancy in New Hampshire. Skelton, KR., Hecht, AA., Benjamin-Neelon, SE.[2020]

In a study of 201 postpartum women, 82.6% wore a wrist accelerometer for at least 7 days at 2-3 weeks postpartum, demonstrating high compliance with the device despite the challenges of early motherhood.

At 5-6 weeks postpartum, 70.1% of participants continued to wear the device for the required duration, with most meeting established wear time standards, indicating that accelerometry can be effectively used to assess physical activity in early postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with wrist-worn accelerometers in primiparous early postpartum women. Wolpern, AE., Sherwin, KJ., Moss, WD., et al.[2022]

Approximately 4.2% of women reported using marijuana during pregnancy, primarily for stress relief, nausea, or pain, highlighting a need for awareness of its potential risks, such as lower birthweight.

Women who continued using marijuana during pregnancy were more likely to be non-Hispanic white, unmarried, have lower education levels, and use cigarettes, indicating specific demographic factors that may influence marijuana use during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Marijuana Use During Pregnancy - Eight States, Pregnancy Risk Assessment Monitoring System, 2017. Ko, JY., Coy, KC., Haight, SC., et al.[2020]

Inactive pregnant women showed an increase in physical activity (PA) during the second trimester, but this was followed by a significant decline in the third trimester, indicating a need for targeted interventions during this period.

Overweight and obese pregnant women were found to be less active, taking significantly fewer steps and engaging in less 'active' time compared to normal weight women, highlighting the importance of addressing weight status in promoting PA during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of objectively-measured physical activity and sedentary time over the course of pregnancy in women self-identified as inactive. Huberty, JL., Buman, MP., Leiferman, JA., et al.[2022]

The study involved 31 pregnant women with overweight/obesity and tested an adaptive intervention aimed at regulating gestational weight gain (GWG), showing that the intervention group had a 21% lower GWG compared to the control group, although this difference was not statistically significant.

Participants in the intervention group also demonstrated significantly lower energy intake post-intervention, indicating that the educational and counseling support may help manage dietary habits during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive, behavioral intervention impact on weight gain, physical activity, energy intake, and motivational determinants: results of a feasibility trial in pregnant women with overweight/obesity. Downs, DS., Savage, JS., Rivera, DE., et al.[2022]

Citations

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Project Details - NIH RePORTER

Physical activity (PA) interventions may play a key role as an alternate coping strategy for distressed pregnant women – thus decreasing CU.

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The study tests if adding lifestyle physical activities (LPA) to Fitbit tracking helps reduce prenatal cannabis use compared to just using a Fitbit.

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centerwatch.com/clinical-trials/listings/NCT06239701/development-of-a-lifestyle-physical-activity-intervention-to-reduce-risk-for-perinatal-cannabis-use-rct

Development of a Lifestyle Physical Activity Intervention to ...

The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during ...

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clinicaltrials.gov/study/NCT06239701?term=fitbit&aggFilters=status:rec&viewType=Table&rank=6

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A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

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Development of a Lifestyle Physical Activity Intervention to ...

Overview. The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy.