Fitbit Device Use in Overweight Pregnancy

NCT06226597 | Active Not Recruiting

• 1 other identifier: 1101840
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Weight Gain; Overweight and Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Number of patients reporting adverse events related to device

  Through duration of participation, average of 8-9 months

• Number of patients lost to follow-up

  18 months

• Incidence of intrauterine growth restriction

  At delivery

• Incidence of fetal macrosomia

  At delivery

• Incidence of gestational hypertension

  At delivery

Study Arms (2)

Fitbit monitoring

EXPERIMENTAL

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

Routine prenatal care

NO INTERVENTION

Individuals in this arm will receive standard prenatal care without the addition of wearing a fitbit device.

Interventions

Fitbit device DEVICE

Daily use of a fitbit wearable activity tracker device.

Fitbit monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center

Tucson, Arizona, 85750, United States

Location

Related 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.

  PMID: 29300720 BACKGROUND

• 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.

  PMID: 19809317 BACKGROUND

• 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.

  PMID: 28586887 BACKGROUND

MeSH Terms

Conditions

Gestational Weight Gain; Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Laura Mroue, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 26, 2024
• Study Start: February 8, 2024
• Primary Completion: April 11, 2025
• Study Completion: June 30, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 6 months of study publication.
• Access Criteria: Access will be available by contacting the study PI for approval.

Locations

US (1)