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Pregnancy Weight GainNCT06226597

Fitbit Device Use in Overweight Pregnancy

A study testing Fitbit device in people with Pregnancy Weight Gain and Overweight and Obesity, run by University of Arizona at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Weight Gain, Overweight and Obesity
What is being tested?
Fitbit device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
8 Feb 2024to 30 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Banner University Medical Center

    Tucson, Arizona, 85750

Other trials in United States

About this study

Official title: Fitbit Device Use in Overweight Pregnant Women to Improve Adherence to Gestational Weight Gain Guidelines

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.

Read the 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
Being tested
Fitbit device
Keywords
Pregnancy, Overweight or obese, Physical activity, Sleep in Pregnancy
Medical subject headings
Gestational Weight Gain, Overweight, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fitbit deviceDevice

    Daily use of a fitbit wearable activity tracker device.

Study groups in NCT06226597
Study groupRoleWhat they receive
Fitbit monitoringExperimentalIndividuals 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.
Receives: Device: Fitbit device
Routine prenatal careNo interventionIndividuals in this arm will receive standard prenatal care without the addition of wearing a fitbit device.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From pre-pregnancy or initial prenatal visit until 6 weeks postpartum

Secondary outcomes (18)

  1. Number of patients reporting adverse events related to device

    Tolerability of wearing the device consistently, any adverse effects

    Measured: Through duration of participation, average of 8-9 months

  2. Number of patients lost to follow-up

    Individuals that discontinue follow-up or study inclusion

    Measured: 18 months

  3. Incidence of intrauterine growth restriction

    Number of pregnancies affected by intrauterine growth restriction

    Measured: At delivery

  4. Incidence of fetal macrosomia

    Number of pregnancies affected by fetal macrosomia

    Measured: At delivery

  5. Incidence of gestational hypertension

    Number of patients who develop gestational hypertension in pregnancy

    Measured: At delivery

  6. Incidence of gestational diabetes

    Number of patients who develop gestational diabetes in pregnancy

    Measured: At delivery

  7. Incidence of preeclampsia

    Number of patients who develop preeclampsia in pregnancy

    Measured: At delivery

  8. Incidence of preterm delivery

    Number of patients who experience preterm delivery

    Measured: At delivery

  9. Incidence of cesarean delivery

    Number of patients who have cesarean delivery

    Measured: At delivery

  10. Neonatal birth weight

    Neonatal birth weight in grams

    Measured: At delivery

  11. Incidence of NICU admission

    Number of fetuses requiring admission to neonatal ICU care

    Measured: At delivery

  12. Average number of daily steps taken per individual

    Average number of daily steps taken per individual as recorded by fitbit device

    Measured: At delivery

  13. Calories burned per individual

    Daily calories burned per individual, as measured by fitbit device, in kcal

    Measured: At delivery

  14. Daily sleep duration

    Daily and average sleep duration in hours per individual, as measured by fitbit device

    Measured: At delivery

  15. Fitbit derived sleep quality

    Fitbit device determined nightly sleep score

    Measured: At delivery

  16. Global Physical Activity Questionnaire (GPAQ) score

    Questionnaire data

    Measured: At initial enrollment, 28 weeks gestation and delivery

  17. Cambridge Worry Scale score

    Questionnaire data

    Measured: At initial enrollment, 28 weeks gestation and delivery

  18. Pittsburg Sleep Quality Index score

    Questionnaire data

    Measured: At initial enrollment, 28 weeks gestation and delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start8 Feb 2024
  3. Primary completion11 Apr 2025
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06226597
Sponsor's protocol ID
1101840
Status last verified
May 2025
First submitted
3 Jan 2024
Last updated
7 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon request and approval by the study team, IPD may be shared with other researchers.

Publications

  • 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.

    PubMed 29300720

  • 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.

    PubMed 19809317

  • 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.

    PubMed 28586887

Questions about this trial

What is this clinical trial studying?

A study testing Fitbit device in people with Pregnancy Weight Gain and Overweight and Obesity, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational weight gain during pregnancy (time frame: From pre-pregnancy or initial prenatal visit until 6 weeks postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06226597, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.

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