Timing of Ambulation and Infant Birth Weight in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Assessment of the Effect of Postprandial Ambulation on Birth Weight Percentile in Patients With Gestational Diabetes Mellitus.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157684
• Other study ID #: GDMAmbulation_WIH
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized controlled trial of postprandial ambulation to decrease birthweight percentile in patients with gestational diabetes.

Patients who are diagnosed with gestational diabetes. and enrolled in the Diabetes in Pregnancy Program in the Division of Maternal Fetal Medicine at Women and Infants Hospital of Rhode Island will be approach for inclusion in the study. After consent is obtained, patients with gestational diabetes. will be randomized into one of two groups.

• Group 1: intervention group: 20 minutes of walking after meals

• Group 2: non-intervention group: routine activity

Randomization will occur via computer generated randomization in blocks of 10. After consent is obtained the participants will be randomized via REDCap. They will then receive counseling specific to their group. They will be provided with an activity monitor and instructed on how to use as well as charge and upload data. They will be provided with the information from the manufacturer as well as trouble shooting guide.

As is the standard of care in this clinic, both groups would be equipped with glucometers and diabetic testing supplies. Both groups would receive the same diabetes and nutrition counseling from qualified nursing staff. Additionally, all participants will be provided with Bluetooth enabled pedometers. Those participants assigned to the intervention group would be instructed to walk for 20 minutes within the first two hours following each meal, while those assigned to the routine activity group will receive standard exercise counseling per American College of Obstetricians and Gynecologists and the American Diabetes Association.

Patients will touch base weekly (either in person or by email) with diabetic nurse educators as is the standard management in this clinic. The decision to start insulin for glucose management will remain up to the discretion of the participant's medical doctor. In addition to review of their glucose logs, patients will review activity log and pedometer data with research staff on a weekly or biweekly basis.

Delivery data will be collected on all patients including routine postpartum laboratory data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Birth Weight
• Diabetes Mellitus
• Diabetes, Gestational
• Fetal Macrosomia
• Gestational Diabetes
• Pregnancy Complications
• Pregnancy in Diabetic
• Pregnancy in Diabetics

Intervention

Behavioral:
• Postprandial ambulation
See arm description

Locations

Country	Name	City	State
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	feasibility and acceptability	Likert scale for participant experience	3 months after the study conclusion
Primary	Infant birthweight percentile	Birthweight percentile for gestational age for neonatal sex	Single time point - at birth
Secondary	infant birthweight	birthweight measured after delivery	Single time point - at birth
Secondary	neonatal hypoglycemia treatment	need for PO or IV treatment for neonatal hypoglycemia	within 48 hours of birth
Secondary	mode of delivery	spontaneous vaginal, operative vaginal, cesarean delivery	Single time point
Secondary	fetal macrosomia	birthweight >4500 gm	Single time point - at birth
Secondary	need for insulin or metformin during pregnancy	need for initiation of anti-hyperglycemic treatment during pregnancy	from diagnosis to delivery of infant