Timing of Ambulation and Infant Birth Weight in Gestational Diabetes

NCT06157684 | Unknown

• 1 other identifier: GDMAmbulation_WIH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Infant birthweight percentile

  Birthweight percentile for gestational age for neonatal sex

  Single time point - at birth

Secondary Outcomes (5)

• infant birthweight

  Single time point - at birth

• neonatal hypoglycemia treatment

  within 48 hours of birth

• mode of delivery

  Single time point

• fetal macrosomia

  Single time point - at birth

• need for insulin or metformin during pregnancy

  from diagnosis to delivery of infant

Other Outcomes (1)

• feasibility and acceptability

  3 months after the study conclusion

Study Arms (2)

Postprandial Ambulation

EXPERIMENTAL

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

Behavioral: Postprandial ambulation

Routine exercise counseling

NO INTERVENTION

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

Interventions

Postprandial ambulation BEHAVIORAL

See arm description

Postprandial Ambulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications; Pregnancy in Diabetics; Fetal Macrosomia

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical and Research Fellow, Principal Investigator

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: December 6, 2023
• Study Start: October 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

US (1)