Fitbit Device Use in Overweight Pregnancy

Fitbit Device Use in Overweight Pregnant Women to Improve Adherence to Gestational Weight Gain Guidelines

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity; Pregnancy Weight Gain
• Intervention / Treatment: Device: Fitbit device

Detailed Description

This is a prospective randomized control trial study. This study aims to assess the relationship between physical activity and sleep metrics in pregnant women as measured using the Fitbit device and the ability to meet Institute of Medicine weight gain guidelines during pregnancy. The hypothesis of the study is that self-realization and monitoring of activity using the Fitbit will encourage the wearer to be increasingly physically active and assist in meeting weight gain guidelines. This study is performed in conjunction with the University of Arizona sensor lab utilizing the MyDataHelps platform which will assist with collection of data from each participant's Fitbit device and subsequent analysis. Mydatahelps is an easily customizable data collection platform that helps researchers collect participant data in a secure HIPAA compliant manner. They are an external company but have no input in the construction of the project This study will have two arms: one with Fitbit wearers and a control arm for routine prenatal care. Compared to control participants who will not have a Fitbit device, we hypothesize that utilization of the Fitbit device will be effective in helping overweight and obese pregnant women meet Institute of Medicine weight gain guidelines.

The primary endpoint is gestational weight gain throughout pregnancy. Weight will be measured pre-pregnancy, at recruitment, 28 weeks, delivery, and 6 weeks postpartum.

Secondary endpoints will also be measured and include:

1. Acceptability of device and loss to follow-up
2. Obstetrical outcomes include rate of developing gestational diabetes, gestational hypertension and preeclampsia, preterm delivery, cesarean delivery rate, intrauterine growth restriction, and macrosomia
3. Neonatal outcomes, including birth weight and admission to NICU
4. Fitbit outcome data, including steps taken, calories burned, sleep duration and Fitbit derived sleep quality
5. Questionnaire data: Global Physical Activity Questionnaire (GPAQ), Cambridge Worry Scale and Pittsburgh Sleep Quality Index at baseline, 28 weeks and delivery

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85750
      • Banner University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At least 18 years old
• Currently pregnant with a singleton pregnancy
• Pre-pregnancy body mass index over 25
• Owns and uses a smartphone
• Agreeable to participate in the study by wearing a fitbit device consistently (day and night) for the duration of pregnancy

Exclusion Criteria:

• Multiple gestations
• Beyond the first trimester at time of initial enrollment
• Known maternal cardiac disease
• Pre-gestational diabetes
• High risk of preterm labor
• Any contraindications to exercise
• Unwilling to wear device consistently or share tracked data

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fitbit monitoring; 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.	Device: Fitbit device; Daily use of a fitbit wearable activity tracker device.
No Intervention: Routine prenatal care; Individuals in this arm will receive standard prenatal care without the addition of wearing a fitbit device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight gain during pregnancy	Weight will be measured pre-pregnancy, at recruitment (ideally initial prenatal visit), 28 weeks gestation, at delivery and 6 weeks postpartum	From pre-pregnancy or initial prenatal visit until 6 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients reporting adverse events related to device	Tolerability of wearing the device consistently, any adverse effects	Through duration of participation, average of 8-9 months
Number of patients lost to follow-up	Individuals that discontinue follow-up or study inclusion	18 months
Incidence of intrauterine growth restriction	Number of pregnancies affected by intrauterine growth restriction	At delivery
Incidence of fetal macrosomia	Number of pregnancies affected by fetal macrosomia	At delivery
Incidence of gestational hypertension	Number of patients who develop gestational hypertension in pregnancy	At delivery
Incidence of gestational diabetes	Number of patients who develop gestational diabetes in pregnancy	At delivery
Incidence of preeclampsia	Number of patients who develop preeclampsia in pregnancy	At delivery
Incidence of preterm delivery	Number of patients who experience preterm delivery	At delivery
Incidence of cesarean delivery	Number of patients who have cesarean delivery	At delivery
Neonatal birth weight	Neonatal birth weight in grams	At delivery
Incidence of NICU admission	Number of fetuses requiring admission to neonatal ICU care	At delivery
Average number of daily steps taken per individual	Average number of daily steps taken per individual as recorded by fitbit device	At delivery
Calories burned per individual	Daily calories burned per individual, as measured by fitbit device, in kcal	At delivery
Daily sleep duration	Daily and average sleep duration in hours per individual, as measured by fitbit device	At delivery
Fitbit derived sleep quality	Fitbit device determined nightly sleep score	At delivery
Global Physical Activity Questionnaire (GPAQ) score	Questionnaire data	At initial enrollment, 28 weeks gestation and delivery
Cambridge Worry Scale score	Questionnaire data	At initial enrollment, 28 weeks gestation and delivery
Pittsburg Sleep Quality Index score	Questionnaire data	At initial enrollment, 28 weeks gestation and delivery

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Laura Mroue, MD, University of Arizona

Publications and helpful links

General Publications

• Goldstein RF, Abell SK, Ranasinha S, Misso M, Boyle JA, Black MH, Li N, Hu G, Corrado F, Rode L, Kim YJ, Haugen M, Song WO, Kim MH, Bogaerts A, Devlieger R, Chung JH, Teede HJ. Association of Gestational Weight Gain With Maternal and Infant Outcomes: A Systematic Review and Meta-analysis. JAMA. 2017 Jun 6;317(21):2207-2225. doi: 10.1001/jama.2017.3635.
• Deputy NP, Dub B, Sharma AJ. Prevalence and Trends in Prepregnancy Normal Weight - 48 States, New York City, and District of Columbia, 2011-2015. MMWR Morb Mortal Wkly Rep. 2018 Jan 5;66(51-52):1402-1407. doi: 10.15585/mmwr.mm665152a3.
• Rasmussen KM, Catalano PM, Yaktine AL. New guidelines for weight gain during pregnancy: what obstetrician/gynecologists should know. Curr Opin Obstet Gynecol. 2009 Dec;21(6):521-6. doi: 10.1097/GCO.0b013e328332d24e.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Actual): April 11, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 4, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Physical activity; Overweight or obese; Sleep in Pregnancy
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Gestational Weight Gain; Overweight; Weight Gain
• Other Study ID Numbers: 1101840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request and approval by the study team, IPD may be shared with other researchers.
• IPD Sharing Time Frame: Within 6 months of study publication.
• IPD Sharing Access Criteria: Access will be available by contacting the study PI for approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No