Recruiting

Observational Study

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT06157684

Conditions

Gestational Diabetes

Pregnancy Complications

Pregnancy in Diabetic

Fetal Macrosomia

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Postprandial ambulation

Study Details

Brief 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

Study ID

NCT06157684

Start date

Oct 1, 2022

Status verified date

Dec, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Oct 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Postprandial Ambulation

Participants are counseled to walk for 20 minutes within 2 hours following meals daily.

no intervention: Routine exercise counseling

Participants are counseled on routine ADA recommendations for 30 minutes of low-impact exercise 5 times a week

Interventions

Postprandial ambulation

See arm description

Primary outcome measure

  • Infant birthweight percentile [ Time Frame: Single time point - at birth ]

Central Contacts and Locations

Locations

Women & Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Anna R Whelan, MD

401-274-1122awhelan@wihri.org

Martha Kole-White, MD

4012741122mkolewhite@kentri.org

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Dec 6, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2023-12-06.