Fitbit Devices for Pregnancy Weight Control

Overseen By Laura Mroue, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Multiple gestations, Cardiac disease, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 29

Duration: 8-9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Fitbit can help pregnant women manage weight gain according to recommended guidelines. Participants will either use a Fitbit to track activity and sleep or receive standard prenatal care without the device. The researchers aim to determine if the Fitbit group achieves better weight management and sleep quality. This trial suits pregnant women at the start of their pregnancy who are overweight or obese, use a smartphone, and are willing to wear the Fitbit daily. As an unphased trial, it offers participants the chance to contribute to innovative research that may enhance prenatal care and personal health management.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Fitbit devices are safe for pregnant women?

Research shows that Fitbit devices are generally safe for pregnant women. Studies have found these devices easy to use and well-liked by users. In past studies with pregnant women, the Fitbit accurately counted steps and helped them track activity levels. No serious problems were reported from using the device. Many users also found it helpful for monitoring health during pregnancy. While more research is needed, current evidence suggests that Fitbit devices safely manage weight gain and track sleep during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Fitbit devices for pregnancy weight control because they offer a unique way to engage expectant mothers in actively managing their health. Unlike standard prenatal care, which typically focuses on periodic check-ups and generalized guidance, Fitbit devices allow for continuous, personalized monitoring of physical activity and other health metrics. This real-time data collection can empower pregnant individuals to make informed lifestyle choices, potentially leading to healthier outcomes for both mother and baby. By integrating technology with prenatal care, this approach could pave the way for more individualized and proactive health management during pregnancy.

What evidence suggests that Fitbit devices are effective for pregnancy weight control?

This trial will compare the use of Fitbit devices with routine prenatal care. Research has shown that Fitbit devices can help non-pregnant women avoid gaining extra weight. Small studies with pregnant women found that these devices accurately count steps, and the women often continue using them. Fitbit devices also track sleep, showing duration and quality. These features might help pregnant women stay active and aware of their sleep patterns, supporting their weight goals. While early results are promising, more research is needed to confirm their effectiveness during pregnancy. ^{1 2 6 7 8}

Who Is on the Research Team?

Laura Mroue, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with a single pregnancy, who are overweight before pregnancy (BMI over 25). They must be willing to wear a Fitbit device day and night throughout the pregnancy and use a smartphone.

Inclusion Criteria

Pre-pregnancy body mass index over 25

Owns and uses a smartphone

Currently pregnant with a singleton pregnancy

Exclusion Criteria

Multiple gestations

Unwilling to wear device consistently or share tracked data

High risk of preterm labor

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental arm will wear a Fitbit device throughout their pregnancy to monitor physical activity and sleep metrics

8-9 months

Visits at initial enrollment, 28 weeks gestation, delivery, and 6 weeks postpartum

Follow-up

Participants are monitored for gestational weight gain and other obstetrical outcomes until 6 weeks postpartum

6 weeks

1 visit (in-person) at 6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Fitbit Device

Trial Overview

The study tests if using a Fitbit device helps overweight pregnant women follow weight gain guidelines better than those without it. It also looks at whether the Fitbit can track sleep quality and duration effectively during pregnancy.

How Is the Trial Designed?

Group I: Fitbit monitoring Experimental Treatment 1 Intervention

Individuals in this arm will wear a fitbit device consistently throughout the duration of their pregnancy, and monitor fitbit data using a platform that connects to their phone. The remainder of prenatal care will be per standard procedure.

Group II: Routine prenatal care Active Control 1 Intervention

Individuals in this arm will receive standard prenatal care without the addition of wearing a fitbit device.

Fitbit Device is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fitbit Device for:

• General wellness and fitness tracking
• Sleep monitoring

Approved in European Union as Fitbit Device for:

• General wellness and fitness tracking
• Sleep monitoring

Approved in Canada as Fitbit Device for:

• General wellness and fitness tracking
• Sleep monitoring

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

The Fitbit Charge 3™ (FC3) was found to be a valid step counter for women with gestational diabetes, accurately measuring steps during both walking and stepping-in-place at cadences of 84 and 100 steps per minute.

Participants reported that stepping-in-place was an acceptable alternative to walking, highlighting the importance of flexibility in physical activity options for women with competing responsibilities during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a consumer-based wearable activity tracker for physical activity goal setting and measuring steps in pregnant women with gestational diabetes mellitus: exploring acceptance and validity. Ehrlich, SF., Maples, JM., Barroso, CS., et al.[2021]

The study involving 150 pregnant women with obesity showed that using a mobile health intervention, including a smartband and app with midwife counseling, resulted in lower gestational weight gain (GWG) compared to usual care, with a median GWG of 7.0 kg in the intervention group versus 9.3 kg in the control group.

Women in the intervention group also reported higher physical activity levels, averaging 1980 metabolic equivalents of tasks-minutes per week compared to 1386 in the control group, indicating that the digital health tools effectively promoted healthier lifestyles without increasing maternal or perinatal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Step Counter Smartband and Midwife Counseling Intervention on Gestational Weight Gain and Physical Activity in Pregnant Women With Obesity (Pas and Pes Study): Randomized Controlled Trial. Gonzalez-Plaza, E., Bellart, J., Arranz, Á., et al.[2022]

Fitbit activity trackers show acceptable accuracy for step counting about half the time, often underestimating steps in controlled settings and overestimating in free-living environments, particularly when used by adults without mobility limitations.

The devices are generally unreliable for measuring energy expenditure and may inaccurately estimate time spent in higher-intensity activities and distance during faster walking, suggesting caution in their use for health research and decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Fitbit Devices: Systematic Review and Narrative Syntheses of Quantitative Data. Feehan, LM., Geldman, J., Sayre, EC., et al.[2020]

Medical students using activity trackers combined with weekly email communication (Fitbit-Plus group) significantly increased their daily step count compared to those using only the trackers (Fitbit-Only group), with an average of 7429 steps versus 6483 steps over the academic year.

The Fitbit-Plus group also showed improvements in body composition, with overweight women experiencing a decrease in body fat percentage and overweight men gaining lean body mass, highlighting the effectiveness of combining behavioral challenges with activity tracking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. DiFrancisco-Donoghue, J., Jung, MK., Stangle, A., et al.[2022]

Approximately 35% of US adults have pre-diabetes, and using consumer devices like Fitbits can help increase physical activity and manage weight, potentially reducing the risk of diabetes and cardiovascular disease.

While initial trials show that wearable devices can boost physical activity and weight loss in overweight individuals, their effectiveness specifically for people with pre-diabetes remains unstudied, highlighting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward research-tested mobile health interventions to prevent diabetes and cardiovascular disease among persons with pre-diabetes. Coughlin, SS., Stewart, JL.[2022]

Cancer survivors using wearable activity trackers, like Fitbits, have shown an increase in physical activity, which is important for reducing negative effects from cancer treatments and improving overall health outcomes.

The review identified 13 relevant studies, including 8 randomized controlled trials, indicating a need for further research to better understand how these devices can effectively promote physical activity and weight management in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of consumer wearable devices to promote physical activity among breast, prostate, and colorectal cancer survivors: a review of health intervention studies. Coughlin, SS., Caplan, LS., Stone, R.[2020]

During pregnancy, the range of motion and velocity of arm movements significantly increase while walking, indicating that pregnant women may rely more on their arms for balance and movement compensation as their bodies change.

These changes in arm motion may affect the accuracy of wearable fitness devices, suggesting that typical gait analyses focusing on lower body movements might overlook important biomechanical adaptations during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper extremity kinematics during walking gait changes through pregnancy. Music, HE., Bailey, JP., Catena, RD.[2023]

Fitbit devices are feasible for monitoring physical activity in children and adolescents with chronic health conditions, potentially improving their overall wellbeing and physical health.

However, the accuracy of Fitbit data is not sufficiently supported by evidence, suggesting that while they can be useful for general health tracking, medical-grade technologies are recommended for collecting precise health data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Fitbit devices among children and adolescents with chronic health conditions: a scoping review. Kasparian, AM., Badawy, SM.[2022]

Women are 2.3 times more likely to use wearable activity trackers compared to men, indicating a gender difference in the adoption of these health-monitoring devices.

Individuals with a higher Body Mass Index (BMI) are more likely to use tracker devices, with a 5.2% increase in odds for each 1-point increase in BMI, suggesting that tracker usage may be more common among those who are overweight or obese.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Habits and Wearable Activity Tracker Devices: Analytical Cross-Sectional Study. Tricás-Vidal, HJ., Lucha-López, MO., Hidalgo-García, C., et al.[2022]

Among adolescent survivors of childhood cancer, only 30.6% consistently used the Fitbit Flex for physical activity tracking in the first 12 weeks, indicating low initial engagement without incentives or reminders.

Despite some positive feedback on self-monitoring and leading a more active lifestyle, overall usage declined significantly over a year, suggesting that additional strategies are needed to maintain interest and engagement with wearable activity trackers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Fitbit Use in Adolescent Survivors of Pediatric Cancer: Who Consistently Uses It and for How Long? Williamson Lewis, R., Howell, KE., Effinger, KE., et al.[2023]

Overweight and obese pregnant women expressed a strong desire to safely manage their weight gain during pregnancy, highlighting their need for support and effective tools, such as mHealth apps, to help them achieve their goals.

Participants reported positive experiences with mHealth apps, which facilitated healthier eating and physical activity, potentially increasing their self-efficacy and adherence to weight management strategies to prevent excessive gestational weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Help me fight my constant battle": A focus group study of overweight and obese women's mHealth app experiences to manage gestational weight gain. Lee, CF., Hsiung, Y., Chi, LK., et al.[2022]

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While the identified trends are based on data from live birth pregnancies, the adverse outcome analysis is intended as a feasibility assessment ...

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bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-021-03900-8

Using a consumer-based wearable activity tracker for physical ...

This study examined the performance of the wrist-worn Fitbit Charge 3™ (FC3) and sought opinions on walking and stepping-in-place from women ...

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Activity tracking devices in pregnancy: Understanding the ...

This device was used to monitor behaviors such as physical activity and sleep. Once the participant delivered their baby, their Fitbit data was ...