Clinical trial NCT06226597: Fitbit Device Use in Overweight Pregnancy
Official title: Fitbit Device Use in Overweight Pregnant Women to Improve Adherence to Gestational Weight Gain Guidelines
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Weight Gain
Overweight and Obesity
Keywords: Pregnancy
Overweight or obese
Physical activity
Sleep in Pregnancy
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Gestational weight gain during pregnancy
timeFrame: From pre-pregnancy or initial prenatal visit until 6 weeks postpartum
Secondary outcomes:
measure: Number of patients reporting adverse events related to device
timeFrame: Through duration of participation, average of 8-9 months
measure: Number of patients lost to follow-up
timeFrame: 18 months
measure: Incidence of intrauterine growth restriction
timeFrame: At delivery
measure: Incidence of fetal macrosomia
timeFrame: At delivery
measure: Incidence of gestational hypertension
timeFrame: At delivery
measure: Incidence of gestational diabetes
timeFrame: At delivery
measure: Incidence of preeclampsia
timeFrame: At delivery
measure: Incidence of preterm delivery
timeFrame: At delivery
measure: Incidence of cesarean delivery
timeFrame: At delivery
measure: Neonatal birth weight
timeFrame: At delivery
measure: Incidence of NICU admission
timeFrame: At delivery
measure: Average number of daily steps taken per individual
timeFrame: At delivery
measure: Calories burned per individual
timeFrame: At delivery
measure: Daily sleep duration
timeFrame: At delivery
measure: Fitbit derived sleep quality
timeFrame: At delivery
measure: Global Physical Activity Questionnaire (GPAQ) score
timeFrame: At initial enrollment, 28 weeks gestation and delivery
measure: Cambridge Worry Scale score
timeFrame: At initial enrollment, 28 weeks gestation and delivery
measure: Pittsburg Sleep Quality Index score
timeFrame: At initial enrollment, 28 weeks gestation and delivery
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Laura Mroue, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.