NCT06226597Active, not recruiting
Fitbit Device Use in Overweight Pregnancy
Fitbit Device Use in Overweight Pregnant Women to Improve Adherence to Gestational Weight Gain Guidelines
Source: ClinicalTrials.gov · Last updated 7 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 3 Jan 2024
- Start date
- Feb 2024
- Primary completion date
- Apr 2025
- Lead sponsor
- University of Arizona
- Diseases
- Obesity
- NCT number
- NCT06226597
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From Feb 2024 to the primary completion date, Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known maternal cardiac disease
- Pre-gestational diabetes
Other
- Multiple gestations
- Beyond the first trimester at time of initial enrollment
- High risk of preterm labor
- Any contraindications to exercise
- Unwilling to wear device consistently or share tracked data
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Banner University Medical Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.