The Snack Study: The Feasibility of Changing Night-time Food Choices to Improve Glucose Tolerance in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in glucose concentrations measured by a glucose tolerance test.
研究概览
简要总结
Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and for obesity and comorbid metabolic disease in the offspring. Results of previous intervention studies designed to improve the metabolic health of obese mothers, and thereby reduce the risk to their offspring, have been modest at best. Furthermore, few studies have proved to be efficacious among low income African American women who have high risk for the transmission of obesity to future generations. The purpose of this study is to examine the feasibility of changing the types of foods and drinks that are consumed at night during late pregnancy in order to improve maternal glucose tolerance and reduce the risk for future obesity in the child.
详细描述
Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and for obesity and comorbid metabolic disease in the offspring. Results of previous intervention studies designed to improve the metabolic health of obese mothers, and thereby reduce the risk to their offspring, have been modest at best. Furthermore, few studies have proved to be efficacious among low income African American women who have high risk for the transmission of obesity to future generations. The purpose of this study is to examine the feasibility of changing the types of foods and drinks that are consumed at night during late pregnancy in order to improve maternal glucose tolerance and reduce the risk for future obesity in the child. We hypothesize that women who replace their usual night-time foods and drinks with lower glycemic load options will have more stable night-time glucose and lower glucose following an oral glucose load. This intervention will be assessed in a cohort of African American women of low income, who were obese at their first prenatal care visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •African American race
- •Healthy, singleton pregnancy
- •≤ 28 weeks' gestation at enrollment
- •BMI of 30.0 - 45.9 kg/m2 at first prenatal visit
- •Reports regular food consumption after 8pm at night that is not attributable to work schedule or other constraints.
排除标准
- •pre-gestation or gestational diabetes
- •current smoker
- •presence of any medical condition or the use of any medication known to affect fetal growth
- •previous delivery of a small-for-gestational age infant (<10th percentile)
- •previous delivery of a pre-term infant (<36.0 weeks' gestation)
- •inability to communicate in both verbal and written English
- •unwilling or unable to consume study-provided foods.
研究组 & 干预措施
Control
Control
Low glycemin load snacks
Low glycemic load snacks, consumed during specific times
干预措施: Low glycemic load snacks (Behavioral)
结局指标
主要结局
Change in glucose concentrations measured by a glucose tolerance test.
时间窗: 5 weeks
次要结局
- Mean amplitude of glucose excursions(5 weeks)
- Fetal growth(5 weeks)
研究者
Paula Chandler-Laney, PhD
Principal Investigator
University of Alabama at Birmingham
