Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Weight change during pregnancy
研究概览
简要总结
The purpose of this study are:
-
Assess the impact of an intervention to the adoption of healthy lifestyles among pregnant women at high risk of gestational diabetes mellitus on:
-
weight gain in pregnancy
-
the levels of maternal and fetal adipokines and
-
glycemic control maternal and fetal.
-
Determine whether the adoption of healthy lifestyles in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.
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
- •be aged ≥ 18 years,
- •have a pre-pregnancy BMI ≥ 25 kg/m2,
- •be at risk of developing a gestational diabetes mellitus (a history of gestational diabetes mellitus or glucose 1 hour post-50g > 7.1 mmol/L.
排除标准
- •Pre-pregnancy diabetes detected in the first trimester (A1c > 6.5%, fasting glucose > 7.0 mmol/L, random blood glucose> 11.1 mmol/L, glucose > 10.3 mmol/L 1 hour post-50g)
- •twin pregnancy
- •taking medications that can affect blood sugar or weight,
- •practice ≥ 150 minutes of physical activity per week
- •against formal-indication for physical activity.
研究组 & 干预措施
Control group
In addition to the usual monitoring of pregnancy, this group will receive information about the recommended weight gain during pregnancy and an evaluation about of their nutritional and physical activity habits.
干预措施: Control group (Behavioral)
Intervention group
This group will receive a regular monitoring by health professionals (nutritionist and kinesiologist) who will ensure nutritional changes and physical activity necessary to secure the adoption of a healthy lifestyle and could participate to a physical activity group session once a week until week 36 of gestation.
The intervention include:
A nutritional counseling every 2 weeks by a nutritionist until week 36 of gestation; a physical activity group session once a week lead by a kinesiologist until week 36 of gestation; 2 sessions of physical activity counseling (weeks 12 and 24).
干预措施: Healthy lifestyle counseling (Behavioral)
结局指标
主要结局
Weight change during pregnancy
时间窗: Weeks 12, 24, 36 of gestation
次要结局
- Levels of maternal and fetal adipokines(Weeks 12, 24 of gestation and at delivery (in cord blood))
- Maternal and fetal glycemic control(Weeks 12, 24 of gestation and at delivery)
- Determine whether the adoption of healthy lifestyle in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.(Weeks 12, 24 of gestation and at delivery (cord blood))
- Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale.(throughout the study)
研究者
Marie-France Hivert
MD, MSc
Université de Sherbrooke