Post-meal Walking for Gestational Diabetes

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Type 1 diabetes, Type 2 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for English or Spanish-speaking pregnant individuals diagnosed with gestational diabetes in the second or third trimester, receiving care at a specific program. It's not for those with pre-existing type 1 or type 2 diabetes, early gestational diabetes diagnosis, or who can't walk due to physical limitations.

Inclusion Criteria

I have gestational diabetes and am getting care at a specific program. I speak English or Spanish.

Exclusion Criteria

I was diagnosed with gestational diabetes in my first trimester.

I cannot walk or have reasons that prevent me from walking.

I have been diagnosed with diabetes (type 1 or 2).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Counseling

Participants are randomized into intervention or non-intervention groups and receive specific exercise counseling

1 week

1 visit (in-person)

Intervention

Participants follow assigned exercise regimen: postprandial ambulation or routine exercise counseling

Until delivery

Weekly check-ins (in-person or email)

Follow-up

Participants are monitored for birth outcomes and postpartum data collection

Up to 48 hours post-birth

1 visit (in-person)

Treatment Details

Interventions

• Postprandial ambulation

Trial Overview The study compares the effects of two types of exercise advice on baby birth weight in gestational diabetes: one group will be told to walk for 20 minutes after meals and another will get standard exercise counseling. Their activity is tracked via FitBit devices.

Participant Groups

Group I: Postprandial Ambulation Experimental Treatment 1 Intervention

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

Group II: Routine exercise counseling Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+