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Fitbit Device Use in Overweight Pregnancy
NCT06226597 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Fitbit device
Study Locations (1)
Arizona
- Banner University Medical Center — Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-02-08 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06226597
The ClinicalTrials.gov registry entry for NCT06226597 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 379 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Overweight and Obesity appearing as the primary indexed condition, and to 1 intervention — of which Fitbit device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06226597 reports 1 study location spanning 1 distinct geographic area — top geographies include Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06226597 about?
NCT06226597 is a clinical study titled "Fitbit Device Use in Overweight Pregnancy". 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 o...
What is the current status of trial NCT06226597?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2024-02-08. Estimated completion is 2025-06-30.
What conditions does trial NCT06226597 study?
This clinical trial studies the following conditions: Overweight and Obesity, Pregnancy Weight Gain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06226597?
The interventions under investigation include: Fitbit device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06226597?
This trial is sponsored by University of Arizona, which has 379 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06226597 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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