Fitbit Device Use in Overweight Pregnancy

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226597
• Other study ID #: 1101840
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University of Arizona
• Contact: Laura Mroue, MD
• Phone: 7346257379
• Email: lmroue[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gestational Weight Gain
• Overweight
• Overweight and Obesity
• Pregnancy Weight Gain
• Weight Gain

Intervention

Device:
• Fitbit device
Daily use of a fitbit wearable activity tracker device.

Locations

Country	Name	City	State
United States	Banner University Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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