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Fitbit Device Use in Overweight Pregnancy

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06226597
Enrollment
70
Registered
2024-01-26
Start date
2024-02-08
Completion date
2025-06-30
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity, Pregnancy Weight Gain

Keywords

Pregnancy, Overweight or obese, Physical activity, Sleep in Pregnancy

Brief summary

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.

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

Interventions

DEVICEFitbit device

Daily use of a fitbit wearable activity tracker device.

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gestational weight gain during pregnancyFrom pre-pregnancy or initial prenatal visit until 6 weeks postpartumWeight will be measured pre-pregnancy, at recruitment (ideally initial prenatal visit), 28 weeks gestation, at delivery and 6 weeks postpartum

Secondary

MeasureTime frameDescription
Number of patients lost to follow-up18 monthsIndividuals that discontinue follow-up or study inclusion
Incidence of intrauterine growth restrictionAt deliveryNumber of pregnancies affected by intrauterine growth restriction
Incidence of fetal macrosomiaAt deliveryNumber of pregnancies affected by fetal macrosomia
Incidence of gestational hypertensionAt deliveryNumber of patients who develop gestational hypertension in pregnancy
Incidence of gestational diabetesAt deliveryNumber of patients who develop gestational diabetes in pregnancy
Incidence of preeclampsiaAt deliveryNumber of patients who develop preeclampsia in pregnancy
Incidence of preterm deliveryAt deliveryNumber of patients who experience preterm delivery
Incidence of cesarean deliveryAt deliveryNumber of patients who have cesarean delivery
Number of patients reporting adverse events related to deviceThrough duration of participation, average of 8-9 monthsTolerability of wearing the device consistently, any adverse effects
Incidence of NICU admissionAt deliveryNumber of fetuses requiring admission to neonatal ICU care
Average number of daily steps taken per individualAt deliveryAverage number of daily steps taken per individual as recorded by fitbit device
Calories burned per individualAt deliveryDaily calories burned per individual, as measured by fitbit device, in kcal
Daily sleep durationAt deliveryDaily and average sleep duration in hours per individual, as measured by fitbit device
Fitbit derived sleep qualityAt deliveryFitbit device determined nightly sleep score
Global Physical Activity Questionnaire (GPAQ) scoreAt initial enrollment, 28 weeks gestation and deliveryQuestionnaire data
Cambridge Worry Scale scoreAt initial enrollment, 28 weeks gestation and deliveryQuestionnaire data
Pittsburg Sleep Quality Index scoreAt initial enrollment, 28 weeks gestation and deliveryQuestionnaire data
Neonatal birth weightAt deliveryNeonatal birth weight in grams

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026