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Behavioural Intervention

Fitbit Devices for Pregnancy Weight Control

N/A
Recruiting
Led By Laura Mroue, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years old
Be older than 18 years old
Must not have
Known maternal cardiac disease
Pre-gestational diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through duration of participation, average of 8-9 months
Awards & highlights

Summary

"This trial aims to provide overweight and obese pregnant women with Fitbit devices to see if they can help these women meet weight gain guidelines during pregnancy. Previous studies have shown that using Fitbit devices can reduce

Who is the study for?
This trial is for pregnant women over 18 with a single pregnancy, who are overweight before pregnancy (BMI over 25). They must be willing to wear a Fitbit device day and night throughout the pregnancy and use a smartphone.
What is being tested?
The study tests if using a Fitbit device helps overweight pregnant women follow weight gain guidelines better than those without it. It also looks at whether the Fitbit can track sleep quality and duration effectively during pregnancy.
What are the potential side effects?
There are no direct medical side effects from using the Fitbit device. However, participants may experience discomfort or skin irritation from wearing the device continuously.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a known heart condition inherited from my mother.
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I had diabetes before becoming pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through duration of participation, average of 8-9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through duration of participation, average of 8-9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gestational weight gain during pregnancy
Secondary outcome measures
Average number of daily steps taken per individual
Calories burned per individual
Cambridge Worry Scale score
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fitbit monitoringExperimental Treatment1 Intervention
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.
Group II: Routine prenatal careActive Control1 Intervention
Individuals in this arm will receive standard prenatal care without the addition of wearing a fitbit device.

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
525 Previous Clinical Trials
155,188 Total Patients Enrolled
14 Trials studying Obesity
880 Patients Enrolled for Obesity
Laura Mroue, MDPrincipal InvestigatorUniversity of Arizona
~34 spots leftby Jun 2025
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