Physical Activity and Fitbit for Reducing Cannabis Use During Pregnancy

Overseen By Cynthia Battle, PhD

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: 5

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 determine if using a Fitbit and engaging in physical activity can help pregnant women reduce cannabis use. There are two groups: one using only a Fitbit (Fitbit Only Intervention) and another combining the Fitbit with physical activity counseling (LPA+Fitbit Intervention). The trial seeks pregnant women who have used cannabis weekly in the past three months and wish to stop or reduce usage. Participants should also feel stressed or anxious, be medically cleared for moderate physical activity, and not currently meet the recommended activity levels. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could improve health outcomes for pregnant women.

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, it does mention that participants should not have started a new form of mental health or substance use treatment within the past 4 weeks.

What prior data suggests that these interventions are safe for pregnant individuals?

Research has shown that Fitbit devices are generally safe and easy to use. Studies suggest that using Fitbits can help people live healthier lives by promoting physical activity. Although specific safety data on using Fitbits to reduce cannabis use during pregnancy is lacking, tracking activity with a Fitbit is usually harmless.

The LPA (Lifestyle Physical Activity) program aims to help pregnant women reduce cannabis use by increasing physical activity. While specific safety data for this program during pregnancy is not available, staying active is often recommended for pregnant women to boost overall health. Using a Fitbit alongside lifestyle changes is not expected to cause any known safety issues.

Overall, the treatments in this study are likely safe because they focus on physical activity and wellness, which are generally considered beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LPA+Fitbit intervention for reducing cannabis use during pregnancy because it offers a novel, non-pharmacological approach that encourages physical activity through personalized support. Unlike traditional treatments that may rely on counseling or medication, this intervention combines low-intensity physical activity with real-time feedback and motivation via a Fitbit, providing pregnant individuals with an engaging and interactive way to manage their cannabis use. The integration of technology through the Fitbit activity tracker allows for continuous monitoring and personalized feedback, potentially increasing adherence and effectiveness. This innovative approach could lead to healthier pregnancies by reducing cannabis use without the side effects associated with medication.

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

This trial will compare two approaches to reducing cannabis use during pregnancy: the "Only Fitbit" arm and the "LPA and Fitbit" arm. Research has shown that combining everyday physical activity with a Fitbit tracker might help reduce cannabis use during pregnancy. Although data on this specific approach is limited, physical activity is known to benefit health and can lead to positive behavior changes. A Fitbit can motivate and help track activity, encouraging a more active lifestyle. This combination might help pregnant women focus on healthier habits, potentially reducing cannabis use. Early findings suggest that promoting physical activity can lead to better overall health outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Cynthia Battle, PhD

Principal Investigator

Butler Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I speak English.

My doctor says I can do moderate exercise while pregnant.

Self-report of cannabis use at least once/week in the 3 months prior to the current pregnancy and desire to not engage in prenatal cannabis use

Exclusion Criteria

Has plan to relocate away from the geographic area during the study intervention or assessment period

I have a moderate or severe addiction, but it's not to cannabis or nicotine.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomly assigned to either a LPA+Fitbit intervention or Fitbit Only control condition for 12 weeks

12 weeks

In-person orientation, telephone counseling, and brief phone surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments extending to the end of pregnancy and into the postpartum period

4 weeks postpartum

Major assessments at end of treatment and 4 weeks postpartum

Postpartum Monitoring

Birth record abstractions to collect information about specific outcomes such as pre-term delivery and low birth weight

1 month post-birth

What Are the Treatments Tested in This Trial?

Interventions

• Fitbit Only
• LPA+Fitbit Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: LPA and Fitbit Experimental Treatment 1 Intervention

The 12-week LPA+Fitbit intervention consists of 3 components: 1. In-Person LPA+Fitbit Orientation 2. Telephone PA counseling sessions. 3. Fitbit activity tracker.

Group II: Only Fitbit Active Control 1 Intervention

The Fitbit Only condition will include 3 components: 1. In-person Fitbit Orientation. 2. Fitbit Activity Tracker. 3. Brief Telephone Check-ins.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

Published Research Related to This Trial

A behavioral-lifestyle intervention supported by a smartphone app significantly improved dietary quality and physical activity among 565 pregnant women with overweight and obesity, leading to lower glycaemic index and reduced intake of free sugars and fats.

The intervention group showed a higher proportion of participants maintaining physical activity compared to the control group, indicating increased motivation and engagement in exercise during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition, Behavior Change and Physical Activity Outcomes From the PEARS RCT-An mHealth-Supported, Lifestyle Intervention Among Pregnant Women With Overweight and Obesity. Ainscough, KM., O'Brien, EC., Lindsay, KL., et al.[2020]

Prenatal cannabis use is associated with increased odds of preterm birth (PTB), small-for-gestational-age (SGA), and perinatal mortality, based on a systematic review of 53 studies, indicating potential risks for fetal and neonatal health.

The evidence is of very-low to low certainty, highlighting the need for more detailed studies that consider the timing and quantity of cannabis use during pregnancy to better understand its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis Use in Pregnancy and Neonatal Outcomes: A Systematic Review and Meta-Analysis. Lo, JO., Shaw, B., Robalino, S., et al.[2023]

A pilot study involving 60 emerging adults (average age 21.7 years) found that social media-delivered interventions focusing on physical activity (PA) led to significant reductions in cannabis-related consequences and impaired driving compared to a control group.

Participants in the intervention groups reported increases in physical activity, with 38.9% to 80.0% of members noting higher activity levels over time, suggesting that PA can be an effective strategy for addressing cannabis use in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social media interventions addressing physical activity among emerging adults who use cannabis: A pilot trial of feasibility and acceptability. Bonar, EE., Chapman, L., Pagoto, S., et al.[2023]

A survey of 605 adult cannabis users in states with legal access found that 81.7% use cannabis while exercising, with co-users reporting more weekly aerobic and anaerobic exercise compared to non-users.

Participants who used cannabis before or after exercise generally felt it improved their enjoyment, recovery, and motivation to exercise, suggesting potential benefits of cannabis use in enhancing physical activity engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The New Runner's High? Examining Relationships Between Cannabis Use and Exercise Behavior in States With Legalized Cannabis. YorkWilliams, SL., Gust, CJ., Mueller, R., et al.[2023]

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]

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]

The pilot studies successfully recruited 11.6% of pregnant smokers, demonstrating that combining smoking cessation support with physical activity counseling is feasible and likely appealing to this population.

Of the women who participated, 25% achieved continuous smoking abstinence by eight months of pregnancy, with those attending at least 85% of sessions also reporting benefits like reduced cravings and improved confidence in quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity as an aid to smoking cessation during pregnancy: two feasibility studies. Ussher, M., Aveyard, P., Coleman, T., et al.[2018]

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]

The LEAP trial is the largest study to investigate the effectiveness of a physical activity intervention for smoking cessation in pregnant women, targeting those who smoke at least one cigarette a day.

The primary goal is to determine if adding supervised exercise and physical activity consultations to usual care can improve smoking cessation rates, with outcomes including both self-reported and biochemically validated abstinence from smoking throughout pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial. Ussher, M., Aveyard, P., Manyonda, I., et al.[2021]

In a study involving 49 women in group prenatal care, 97% reported enjoying the activity tracking device (ATD), and 100% would recommend it to a friend, indicating high satisfaction despite low adherence (47% wore it daily).

As pregnancy progressed, women showed decreased activity levels and increased sedentary time, highlighting the need for further research to encourage physical activity during later stages of pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity Tracking Devices in Group Prenatal Care: A Feasibility Study. Kominiarek, MA., Vyhmeister, H., Balmert, LC., et al.[2023]

A study of 281,025 pregnancies found that self-reported prenatal cannabis use was significantly lower (2.5%) than what urine toxicology tests revealed (4.9%), indicating that many women do not disclose their cannabis use during pregnancy.

The sensitivity of self-reported cannabis use was low at 33.9%, suggesting that healthcare providers should proactively educate all pregnant patients about the risks of cannabis use and encourage them to quit, as many may not accurately report their usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of Self-reported Cannabis Use Among Pregnant Females in Northern California. Young-Wolff, KC., Sarovar, V., Tucker, LY., et al.[2021]

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 over 12,000 pregnant women, 5% reported using cannabis, but this use was not linked to an increased risk of perinatal death or the need for special care for newborns.

Frequent cannabis use (at least once per week) during pregnancy was associated with a slight decrease in birthweight, with babies being on average 90 grams lighter than those of non-users, although this finding was not statistically significant after adjusting for other factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal use of cannabis and pregnancy outcome. Fergusson, DM., Horwood, LJ., Northstone, K.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06239701

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 pregnancy. Detailed ...

2. withpower.com withpower.com/trial/phase-marijuana-abuse-2024-fe97e

Physical Activity and Fitbit for Reducing Cannabis Use ... Trial Overview The study is testing two approaches to help reduce cannabis use during pregnancy: one group will receive a lifestyle physical activity (LPA) ...

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

Study Details | Development of a Lifestyle Physical Activity ... 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.

4. withpower.com withpower.com/trial/phase-pregnant-state-8-2022-3ea9e

LPA + Fitbit Intervention for Reducing Cannabis Use ... 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 ...

5. centerwatch.com 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7589007/

Fitbit-Based Interventions for Healthy Lifestyle Outcomes The use of Fitbit devices in interventions has the potential to promote healthy lifestyles in terms of physical activity and weight.