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

Trial Summary

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 data supports the effectiveness of the treatment Fitbit-Based Physical Activity Intervention for reducing cannabis use during pregnancy?

There is no direct evidence from the provided research articles about the effectiveness of Fitbit-Based Physical Activity Intervention for reducing cannabis use during pregnancy. However, one study suggests that physical activity can be a useful intervention target for cannabis use, indicating potential utility in this context. ^{1 2 3 4 5}

Is using a Fitbit-based physical activity intervention generally safe for humans?

There is no specific safety data available for Fitbit-based physical activity interventions in the context of reducing cannabis use during pregnancy, but using a Fitbit for tracking physical activity is generally considered safe for most people. ^{1 3 6 7 8}

How does the LPA+Fitbit treatment differ from other treatments for reducing cannabis use during pregnancy?

The LPA+Fitbit treatment is unique because it combines lifestyle physical activity with the use of a Fitbit, a wearable device that tracks physical activity, to help reduce cannabis use during pregnancy. This approach leverages the motivational and tracking capabilities of the Fitbit to encourage increased physical activity, which is not a standard treatment for cannabis use during pregnancy. ^{9 10 11 12 13}

What is the purpose of this trial?

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

Research Team

Cynthia Battle, PhD

Principal Investigator

Butler Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Routes of cannabis administration among females in the year before and during pregnancy: Results from a pilot project. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Social media interventions addressing physical activity among emerging adults who use cannabis: A pilot trial of feasibility and acceptability. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Association between maternal cannabis use and birth outcomes: an observational study. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Validity of Self-reported Cannabis Use Among Pregnant Females in Northern California. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The New Runner's High? Examining Relationships Between Cannabis Use and Exercise Behavior in States With Legalized Cannabis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Characteristics of Marijuana Use During Pregnancy - Eight States, Pregnancy Risk Assessment Monitoring System, 2017. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Cannabis Use in Pregnancy and Neonatal Outcomes: A Systematic Review and Meta-Analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Maternal use of cannabis and pregnancy outcome. [2022]

9. United States 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Physical activity as an aid to smoking cessation during pregnancy: two feasibility studies. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Activity Tracking Devices in Group Prenatal Care: A Feasibility Study. [2023]

13. Switzerland 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. [2020]