A Randomized Trial of a Low Carbohydrate Diet Versus the Current Recommended Dietary Guidelines to Improve Health Outcomes in Obese Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
研究概览
简要总结
The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women.
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
- •Delivery at University of Texas Medical Branch
- •Body max index greater than or equal to 30 kilograms/meters squared at the final prenatal visit prior to delivery.
- •Singleton gestation.
- •Accessibility to the internet.
- •Basic understanding and comprehension of the English language to be assessed by study personnel at the time of recruitment.
排除标准
- •Diabetes mellitus on medication.
- •Serious medical condition, such as heart failure, kidney failure, or severe asthma, as determined by the principle investigator.
- •Planned pregnancy during study period.
- •Enrolled in another trial that may affect outcome.
- •Subject unlikely to be followed up after delivery.
研究组 & 干预措施
Standard of care
Subjects will receive standard counseling on obesity as part of routine postpartum care.
Low carbohydrate diet education
Subjects will receive educational materials regarding a low carbohydrate diet in addition to the standard counseling on obesity as part of routine postpartum care.
干预措施: Low carbohydrate diet education (Behavioral)
Low carbohydrate diet education with behavioral component
Subjects will receive in person instruction regarding a low carbohydrate diet as part of a 12 week course, in addition to receiving educational materials regarding a low carbohydrate diet and the standard counseling on obesity as part of routine postpartum care.
干预措施: Low carbohydrate diet education (Behavioral)
Low carbohydrate diet education with behavioral component
Subjects will receive in person instruction regarding a low carbohydrate diet as part of a 12 week course, in addition to receiving educational materials regarding a low carbohydrate diet and the standard counseling on obesity as part of routine postpartum care.
干预措施: Low carbohydrate diet education with behavioral component (Behavioral)
结局指标
主要结局
Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.
时间窗: Baseline, 3 months
Homeostatic model assessment for measurement of insulin sensitivity will be computed with fasting insulin and glucose levels (fasting for at least 8 hours) with the following calculation: (glucose x insulin/22.5). This calculation is measured in molar units (mmol/L).
次要结局
- Change in weight measured in pounds.(Baseline, 6 months)
- Change in insulin sensitivity as measured by homeostatic model assessment of insulin sensitivity.(Baseline, 6 months)
- Development of diabetes postpartum as measured by 2 hour glucose tolerance test.(3 months)
- Change in blood pressure as measured by blood pressure cuff in mmHg.(Baseline, 6 months)
- Change in weight measured in pounds.(Baseline, 3 months)
- Change in blood pressure as measured by blood pressure cuff in mmHg.(Baseline, 3 months)