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Physical Activity Intervention for Gestational Diabetes

N/A

Waitlist Available

Led By Samantha F Ehrlich, PhD

Research Sponsored by The University of Tennessee, Knoxville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6 weeks

Awards & highlights

Study Summary

This trial will compare the effects of a physical activity intervention versus a general wellness intervention on physical activity levels, maternal glycemic profile, and infant size and anthropometric measurements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Physical Activity Assessed by ActiGraph Monitoring Device From Baseline to Follow-up

Change in Self-reported Physical Activity (Assessed by Pregnancy Physical Activity Questionnaire) From Baseline to Follow-up

Secondary outcome measures

Birthweight-for-gestational-age Z-score

Neonatal Subscapular Skinfolds

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Physical Activity InterventionExperimental Treatment1 Intervention

The behavioral physical activity (PA) intervention focuses on walking, or stepping in place when it is not possible to walk (e.g., stormy weather). The primary goal of the PA intervention is to achieve at least 30 minutes per day of walking/stepping in place. The secondary goal is to use a PA tracker (e.g., the Fitbit Charge 3 provided by the intervention) to log and review walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of walking/stepping each day.

Group II: Wellness EducationActive Control1 Intervention

The Wellness Education intervention will deliver information on mom and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., immunizations during pregnancy and encouragement to immunize the baby on schedule, postpartum contraceptive options and developing a contraceptive plan, infant car seats & safety checks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Activity Intervention

2020

N/A

~990

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Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,572 Total Patients Enrolled

The University of Tennessee, KnoxvilleLead Sponsor

83 Previous Clinical Trials

18,539 Total Patients Enrolled

Samantha F Ehrlich, PhDPrincipal InvestigatorAssistant Professor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment begun for this clinical experiment?

"Clinicaltrials.gov states that this clinical trial, which was first opened on August 21st 2020 and last edited on September 20th 2022, is not presently enrolling patients. However, 103 other studies are currently seeking participants for their trials."

Answered by AI

Who are the eligible participants of this research endeavor?

"Patients aged between 18 and 40 with a diagnosis of gestational diabetes are eligible to partake in this clinical trial, which is recruiting approximately 20 participants."

Answered by AI