NCT06646965招募中不适用
Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,374
- 试验地点
- 4
- 主要终点
- Maternal weight change
研究概览
简要总结
The study aims to evaluate the efficacy of a family-based dietary monitoring during pregnancy on gestational weight gain in pregnant women. The study will be conducted as a randomized controlled trial, women will be randomly allocated into two groups: a group receiving family-based dietary monitoring, and a control group receiving individual dietary monitoring per standard recommendation.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult (+18 years old) Pregnant woman who can be accompanied by a member of the household, adult sharing at least 1 meal per day with her. Affiliated to the social security. French speaking person (read/written and spoken). Single pregnancy between 8 SA and 16 SA. Starting BMI between 18.5 and 35
排除标准
- •Person under legal protection or guardianship
- •Women suffering from a disease requiring a dietary follow-up:
- •Type 1 or type 2 diabetes.
- •Gestational diabetes diagnosed on the basis of fasting blood sugar.
- •History of bariatric surgery.
- •Eating disorders.
- •Metabolic pathologies leading to special diets (phenylketonuria).
- •Digestive pathologies (with an indication) with special diets
- •Women who have lost more than 10% of their weight at the beginning of pregnancy
结局指标
主要结局
Maternal weight change
时间窗: delivery
Maternal weight change will be calculated from the difference between the weight at delivery and the pre-pregnancy weight,
次要结局
- evaluation of BMI during pregnancy(from day 0 to delivery)
- Weight of the baby at birth(delivery)
- The women's nutritional intake and its distribution(16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation)
- Screening for gestational diabetes(16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation)
- Maternal weight loss(6 months after delivery)
- Compliance(24 weeks of gestation, 34 weeks of gestation, 6 months after delivery)
- Physical activity(16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation)
- The support of the entourage(34 weeks of gestation, 6 months after delivery)
- Women's satisfaction with their follow-up during pregnancy(34 weeks of gestation, 6 months after delivery)
- Direct medical, non-medical and indirect costs, valued from the French Healthcare insurance(from day 0 to 6 months after delivery)
研究者
研究点 (4)
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