Assessment of the Effect of Postprandial Ambulation on Birth Weight Percentile in Patients With Gestational Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Infant birthweight percentile
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Postprandial Ambulation
Participants are counseled to walk for 20 minutes within 2 hours following meals daily.
干预措施: Postprandial ambulation (Behavioral)
Routine exercise counseling
Participants are counseled on routine ADA recommendations for 30 minutes of low-impact exercise 5 times a week
结局指标
主要结局
Infant birthweight percentile
时间窗: Single time point - at birth
Birthweight percentile for gestational age for neonatal sex
次要结局
- fetal macrosomia(Single time point - at birth)
- neonatal hypoglycemia treatment(within 48 hours of birth)
- need for insulin or metformin during pregnancy(from diagnosis to delivery of infant)
- infant birthweight(Single time point - at birth)
- mode of delivery(Single time point)
研究者
Anna Whelan
Clinical and Research Fellow, Principal Investigator
Women and Infants Hospital of Rhode Island