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Timing of Ambulation and Infant Birth Weight in Gestational Diabetes

NCT06157684 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-12-06

No results posted yet for this study

Summary

This is a randomized controlled trial to assess the effect of routine exercise counseling compared to the recommendation for postprandial ambulation on infant birthweight among pregnant people with gestational diabetes mellitus.

The primary outcome is birthweight percentile for gestational age at delivery.

Secondary outcomes include feasibility and acceptability, need for metformin or insulin for glycemic control, mode of delivery, neonatal hypoglycemia.

Participants will be counseled to either complete 20 minutes of walking after meals, or be counseled with routine exercise counseling of 30 minutes of low-impact 5x a week. Their activity will be tracked by "FitBit" pedometers and uploaded via bluetooth to a database for review. They will continue to receive routine obstetric and diabetes care.

Conditions

  • Gestational Diabetes
  • Pregnancy Complications
  • Pregnancy in Diabetic
  • Fetal Macrosomia

Interventions

BEHAVIORAL

Postprandial ambulation

See arm description

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06157684 on ClinicalTrials.gov