Appropriate Gestational Weight Gain in Overweight/Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 4
- 主要终点
- Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week
研究概览
简要总结
The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record)
排除标准
- •Cardiovascular disease
- •Gastrointestinal disease
- •Bariatric surgery
- •Lung disease
- •Thyroid disease
- •Eating disorder
- •Bed rest or Gestational Diabetes in the current pregnancy
- •Planning to get pregnant again or move within 1 year of delivery
- •Substance abuse
- •Serious mental health disorders
结局指标
主要结局
Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week
时间窗: from pre-pregnancy weight up to 21 weeks to 42 weeks of pregnancy
Rate of gestational weight gain per week
时间窗: From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy
次要结局
- Diet - proportion of calories from fat(Change in proportion of calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation)
- Physical Activity(Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Rate of gestational weight gain between study clinical assessments(Rate of gestational weight gain between approximately 10 weeks and 32 weeks gestation (kilograms per week))
- Metabolic marker - leptin(Change in leptin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Metabolic marker - adiponectin(Change in adiponectin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Total gestational weight gain(from pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks)
- Proportion of women exceeding the Institute of Medicine's recommendation for total gestational weight gain per week(From pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks)
- Diet - total calories from fat(Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation)
- Metabolic marker - glycemia(Change in glucose between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Metabolic marker - lipids(Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Metabolic marker - insulinemia(Change in insulin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))