Clinical trial

Fitbit Device Use in Overweight Pregnancy

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06226597

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersAccepted

ConditionPregnancy Weight Gain, Overweight and Obesity

Full registry 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

Treatments and study arms

Fitbit device

Device

Daily use of a fitbit wearable activity tracker device.

Primary outcomes

Gestational weight gain during pregnancyFrom 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Banner University Medical Center🇺🇸 Tucson, Arizona, United States

Open map