Timing of Ambulation and Infant Birth Weight in Gestational Diabetes
Status unconfirmed · Not applicable
Conditions studied: Gestational Diabetes, Pregnancy Complications, Pregnancy in Diabetic, Fetal Macrosomia
In brief
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.
Key facts
- Study ID
- NCT06157684
- Run by
- Women and Infants Hospital of Rhode Island
- People needed
- 90
- Starts
- 2022-10-01
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2023-12-06
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients who are diagnosed with gestational diabetes and receive care at the Maternal Fetal Medicine Diabetes in Pregnancy Program and who are fluent in English or Spanish.
You may not qualify if…
- Pre-existing type 1 or type 2 diabetes, and those diagnosed with gestational diabetes in the first trimester. Patients who are either physically unable to ambulate or who have other contraindications to ambulation.
Where it is running
- Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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