Timing of Ambulation and Infant Birth Weight in Gestational Diabetes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Gestational Diabetes; Fetal Macrosomia; Pregnancy in Diabetic
• Intervention / Treatment: Behavioral: Postprandial ambulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • Women & Infants Hospital of Rhode Island
      • Contact: Anna R Whelan, MD; Phone Number: 401-274-1122; Email: awhelan@wihri.org
      • Contact: Martha Kole-White, MD; Phone Number: 4012741122; Email: mkolewhite@kentri.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postprandial Ambulation; Participants are counseled to walk for 20 minutes within 2 hours following meals daily.	Behavioral: Postprandial ambulation; See arm description
No Intervention: Routine exercise counseling; Participants are counseled on routine ADA recommendations for 30 minutes of low-impact exercise 5 times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant birthweight percentile	Birthweight percentile for gestational age for neonatal sex	Single time point - at birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infant birthweight	birthweight measured after delivery	Single time point - at birth
neonatal hypoglycemia treatment	need for PO or IV treatment for neonatal hypoglycemia	within 48 hours of birth
mode of delivery	spontaneous vaginal, operative vaginal, cesarean delivery	Single time point
fetal macrosomia	birthweight >4500 gm	Single time point - at birth
need for insulin or metformin during pregnancy	need for initiation of anti-hyperglycemic treatment during pregnancy	from diagnosis to delivery of infant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility and acceptability	Likert scale for participant experience	3 months after the study conclusion

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Estimated): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Body Weight; Fetal Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Birth Weight; Pregnancy Complications; Diabetes, Gestational; Pregnancy in Diabetics; Fetal Macrosomia
• Other Study ID Numbers: GDMAmbulation_WIH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No