Fitbit Devices for Pregnancy Weight Control

Recruiting in Palo Alto (17 mi)

Overseen by Laura Mroue, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

Disqualifiers: Multiple gestations, Cardiac disease, Diabetes, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

There are set guidelines for weight gain developed by the Institute of Medicine in pregnancy but about three quarters of women gain an inappropriate weight during pregnancy. Many studies have assessed ways to decrease weight gain in these women who gain excess weight, usually through a combination of diet and exercise. Still, often these interventions are difficult to implement, expensive, or have low acceptability. Wearable Fitbit devices have been on the market for years and slowly becoming more inexpensive and easier to use. Previous studies on non-pregnant women have shown that using the device can help reduce weight gain. In addition, small studies in pregnant women have shown they are accurate for measuring steps and have high acceptability and retention rates. The ability of the Fitbit to assess metrics of sleep including sleep duration and quality will also be assessed. This project aims to provide overweight and obese pregnant women at the beginning of their pregnancy with the Fitbit device and with regular follow-up to assess if there is effectiveness in increasing the rate of women who meet weight gain guidelines compared to women without the device along with measuring aspects of sleep.

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 data supports the effectiveness of the treatment Fitbit Device, Fitbit Tracker, Fitbit Wearable Device for pregnancy weight control?

Research shows that Fitbit devices help users become more physically active and manage their weight, which has been effective in reducing the risk of diabetes and cardiovascular disease. Additionally, these devices have been used successfully in lifestyle interventions to increase physical activity among cancer survivors, suggesting potential benefits for weight control during pregnancy. ^{1 2 3 4 5}

Is it safe to use Fitbit devices for health monitoring?

Fitbit devices are generally considered safe for use in health monitoring. They have been used in various studies, including those involving children, adolescents, and adults, without any reported safety concerns. ^{1 2 6 7 8}

How is the Fitbit Device treatment different from other treatments for pregnancy weight control?

The Fitbit Device is unique because it is a wearable activity tracker that helps pregnant women monitor their physical activity and set goals, unlike traditional treatments that may not involve real-time tracking or feedback. It promotes healthy lifestyle changes by providing immediate data and motivation, which can be particularly beneficial for managing weight during pregnancy. ^{2 8 9 10 11}

Research Team

Laura Mroue, MD

Principal Investigator

University of Arizona

Eligibility Criteria

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

I am 18 years old or older.

Pre-pregnancy body mass index over 25

Owns and uses a smartphone

Exclusion Criteria

Multiple gestations

Unwilling to wear device consistently or share tracked data

High risk of preterm labor

Trial Timeline

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

Treatment Details

Interventions

• Fitbit Device (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Richard Carmona

University of Arizona

Chief Medical Officer since 2021

MD, University of Arizona

Dr. Evan Unger

University of Arizona

Chief Executive Officer since 2021

PhD in Medical Imaging, University of Arizona

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

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

2. Canada pubmed.ncbi.nlm.nih.gov

Accuracy of Fitbit Devices: Systematic Review and Narrative Syntheses of Quantitative Data. [2020]

3. China pubmed.ncbi.nlm.nih.gov

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

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

Feasibility of Fitbit Use in Adolescent Survivors of Pediatric Cancer: Who Consistently Uses It and for How Long? [2023]

5. United States 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. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Health Habits and Wearable Activity Tracker Devices: Analytical Cross-Sectional Study. [2022]

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

Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. [2022]

8. England 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. [2021]

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

Upper extremity kinematics during walking gait changes through pregnancy. [2023]

10. Canada 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. [2022]

11. Scotland 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. [2022]