Fitbit Device Use in Overweight Pregnancy
- Conditions
- Pregnancy Weight GainOverweight and Obesity
- Interventions
- Device: Fitbit device
- Registration Number
- NCT06226597
- Lead Sponsor
- University of Arizona
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fitbit monitoring Fitbit device 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.
- Primary Outcome Measures
Name Time Method Gestational weight gain during pregnancy From pre-pregnancy or initial prenatal visit until 6 weeks postpartum Weight will be measured pre-pregnancy, at recruitment (ideally initial prenatal visit), 28 weeks gestation, at delivery and 6 weeks postpartum
- Secondary Outcome Measures
Name Time Method Number of patients reporting adverse events related to device Through duration of participation, average of 8-9 months Tolerability of wearing the device consistently, any adverse effects
Number of patients lost to follow-up 18 months Individuals that discontinue follow-up or study inclusion
Incidence of fetal macrosomia At delivery Number of pregnancies affected by fetal macrosomia
Incidence of gestational hypertension At delivery Number of patients who develop gestational hypertension in pregnancy
Incidence of cesarean delivery At delivery Number of patients who have cesarean delivery
Daily sleep duration At delivery Daily and average sleep duration in hours per individual, as measured by fitbit device
Neonatal birth weight At delivery Neonatal birth weight in grams
Average number of daily steps taken per individual At delivery Average number of daily steps taken per individual as recorded by fitbit device
Global Physical Activity Questionnaire (GPAQ) score At initial enrollment, 28 weeks gestation and delivery Questionnaire data
Pittsburg Sleep Quality Index score At initial enrollment, 28 weeks gestation and delivery Questionnaire data
Incidence of intrauterine growth restriction At delivery Number of pregnancies affected by intrauterine growth restriction
Incidence of gestational diabetes At delivery Number of patients who develop gestational diabetes in pregnancy
Incidence of preeclampsia At delivery Number of patients who develop preeclampsia in pregnancy
Calories burned per individual At delivery Daily calories burned per individual, as measured by fitbit device, in kcal
Fitbit derived sleep quality At delivery Fitbit device determined nightly sleep score
Incidence of preterm delivery At delivery Number of patients who experience preterm delivery
Incidence of NICU admission At delivery Number of fetuses requiring admission to neonatal ICU care
Cambridge Worry Scale score At initial enrollment, 28 weeks gestation and delivery Questionnaire data
Trial Locations
- Locations (1)
Banner University Medical Center
🇺🇸Tucson, Arizona, United States