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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through duration of participation, average of 8-9 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gestational weight gain during pregnancy

Secondary study objectives

Average number of daily steps taken per individual

Calories burned per individual

Cambridge Worry Scale score

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met