LPA + Fitbit Intervention for Reducing Cannabis Use During Pregnancy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Butler Hospital

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

Is the LPA + Fitbit intervention safe for use during pregnancy?

The studies suggest that using a Fitbit to monitor physical activity is generally safe for pregnant women, as it has been used in various interventions without reported safety issues. However, the specific combination of LPA (light physical activity) and Fitbit for reducing cannabis use during pregnancy has not been directly studied for safety. ^{1 2 3 4 5}

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

The LPA + Fitbit intervention is unique because it combines a physical activity component with the use of a Fitbit device to help reduce cannabis use during pregnancy. This approach is novel as it focuses on promoting physical activity as a behavioral change strategy, rather than directly addressing cannabis use through traditional methods like counseling or medication. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Fitbit Only (Behavioral Intervention)
• LPA+Fitbit intervention (Behavioral 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.

Participant Groups

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+

Matt Schnur

Butler Hospital

Chief Executive Officer

Doctor of Pharmacy from Duquesne University

Dr. Monique Butler

Butler Hospital

Chief Medical Officer since 2018

MD from Wayne State University, MBA from the University of Tennessee

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Compliance with wrist-worn accelerometers in primiparous early postpartum women. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of a Sedentary Behavior Reduction Program during Pregnancy: A Semi-Experimental Study. [2020]

4. United States 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. [2022]

5. United States 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. [2022]

6. 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]

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

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

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

Women's cannabis use before, during, and after pregnancy in New Hampshire. [2020]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Development of SmokeFree Baby: a smoking cessation smartphone app for pregnant smokers. [2022]