An interventional study of Postprandial ambulation in Gestational Diabetes, Pregnancy Complications and Pregnancy in Diabetic, sponsored by Women and Infants Hospital of Rhode Island. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Treatment
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.
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.
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.
32 studies on the registry are indexed under Fetal Macrosomia; 6 are open to participants now.
This study's planned enrollment of 90 is below the median of 222 across 13 interventional studies indexed under Fetal Macrosomia.
Browse Fetal Macrosomia studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
Compared within Fetal Macrosomia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes, Gestational. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants are counseled to walk for 20 minutes within 2 hours following meals daily.
Behavioral: Postprandial ambulation
Participants are counseled on routine ADA recommendations for 30 minutes of low-impact exercise 5 times a week
See arm description
Infant birthweight percentile
Birthweight percentile for gestational age for neonatal sex
Time frame: Single time point - at birth
infant birthweight
birthweight measured after delivery
Time frame: Single time point - at birth
neonatal hypoglycemia treatment
need for PO or IV treatment for neonatal hypoglycemia
Time frame: within 48 hours of birth
mode of delivery
spontaneous vaginal, operative vaginal, cesarean delivery
Time frame: Single time point
fetal macrosomia
birthweight \>4500 gm
Time frame: Single time point - at birth
need for insulin or metformin during pregnancy
need for initiation of anti-hyperglycemic treatment during pregnancy
Time frame: from diagnosis to delivery of infant
feasibility and acceptability
Likert scale for participant experience
Time frame: 3 months after the study conclusion
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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Women and Infants Hospital of Rhode Island