Evaluation of Nutritional Interventions to Limit Gestational Weight Gain in Women With Class III Obesity (BMI >40)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Gestational weight gain
研究概览
简要总结
Women with obesity who gain more weight than recommended during pregnancy are more likely to have problems such as cesarean delivery, diabetes in pregnancy, high blood pressure, and larger babies. Standard prenatal care does not usually include nutrition counseling based on weight alone. This trial tested whether adding group nutrition classes during pregnancy helps these women gain less weight during pregnancy compared to standard prenatal care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Prenatal care <12 weeks gestation at University of Alabama at Birmingham
- •Body mass index ≥ 30 at first prenatal visit;
排除标准
- •Multiple gestation
- •pre-gestational diabetes mellitus
- •history of bariatric surgery
研究组 & 干预措施
Usual care
Participants received standard prenatal care at UAB, which does not include nutrition counseling based on obesity alone.
Usual Care plus Nutrition Education
Nutrition education included 1) review of recommendations for GWG and physical activity, 2) review of a unique nutrition topic, 3) a recorded cooking demonstration, and 4) receipt of ingredients for the recorded recipe.
干预措施: Nutrition education (Behavioral)
结局指标
主要结局
Gestational weight gain
时间窗: From first prenatal visit to delivery
Weight difference from first prenatal visit to weight recorded at delivery, analyzed as a continuous outcome
次要结局
- Gestational weight gain within guidelines(from first prenatal visit to delivery)
- 1-hour serum glucose after 50 gram oral glucose challenge test(24-28 weeks gestational age (but can occur greater than 20 weeks gestational age to delivery))
- Abnormal 1-hour serum glucose after 50 gram oral glucose challenge test(24-28 weeks gestational age (but can occur greater than 20 weeks gestational age to delivery))
- Gestational diabetes mellitus(From enrollment to delivery)
- Pregnancy induced hypertension(From 20 weeks gestational age to 6 weeks postpartum)
- Postpartum weight at 6 weeks(six weeks postpartum)
- Mode of delivery(at delivery)
- Shoulder dystocia(at delivery)
- Birthweight(At delivery)
- Infant weight at 6 weeks postpartum(6 weeks postpartum)
- Neonatal length(At delivery)
- Neonatal head circumference(At delivery)
- Neonatal abdominal circumference(At delivery)
- Infant head circumference(At 6 weeks postpartum)
研究者
Akila Subramaniam
Professor
University of Alabama at Birmingham