Obesity and Pregnancy : Study of Factors Influencing Participation in a Program Combining Physical Activity and Nutritional Counseling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Number of participant that will participate to the program
研究概览
简要总结
Background:
Obesity increasingly affects young women and contributes to increased maternal, fetal and neonatal complications. Maternal obesity contributes to the subsequent development of childhood obesity not only through social and environmental mechanisms but also through biological processes referring to the original concept of the developmental health and disease. Data suggest that management during pregnancy through nutrition counseling and adequate physical activity will help to break the familial vicious circle of obesity. To help program to be effective it is important to understand the factors that modulate participation. However, few studies have been conducted to assess the determinants that influence participation.
Goal:
The main objective is to analyze 15 factors that influence participation in a program combining physical activity and nutritional counseling among pregnant women with BMI ≥ 25 kg/m2. Secondary objectives are :
- to identify the data that influence adherence and to show that assiduous women will have a better control of weight gain and a reduction of maternal and fetal complications.
- to understand the biological mechanisms involved
Strategy and method:
A prospective research evaluating the participation in an educational program, including nutritional support and adequate physical activity, will be offered to overweight and obese pregnant women. The program will last 12 weeks, and will include three workshops on diet of the pregnant and lactating women, and the young child. Physical activity sessions will be offered once a week. Fifteen independent variables likely to influence participation will be analyzed. The association between participation and the risk of maternal and fetal pregnancy complications related to obesity will be analysed. Meanwhile, more fundamental research will be considered to determine of the biological factors involved.
详细描述
This is a prospective study that will be conducted in pregnant women with a BMI ≥ 25 kg/m2, aged from 18 to 42 years. Participation in the program will be offered between 12 and 22 + 6 weeks of pregnancy. Women with a history of more than 2 miscarriages, severe heart disease (arrhythmia, previous myocardial infarction), bleeding in the first trimester, multiple pregnancy, unstable thyroid disease, hypertension, diabetes, or any other medical conditions that can interfere with the practice of physical activity during pregnancy will not be allowed to participate in the program for medical reasons. The participants will sign an informed consent. The intervention will be an educational program called "Eat well, move well for to the baby's health," including nutritional counselling and physical activity exercises. The control group will receive usual care as a simple information. The intervention will take place between 24 and 36 weeks of pregnancy. Women will be evaluated before (20-24 weeks gestation (SA)), during the intervention (32-34 SA), and finally 8 weeks after childbirth during the postnatal visit. All patients with benefit from obstetric monitoring according with the French recommendations with a monthly consultation and ultrasonography exams at 22 and 32 wks.
Nutritional support will include 3 workshops of 2 hours within the 12 weeks (one workshop per month). Each workshop session will be conducted in groups of 10 to 15 participants. These workshops will aim firstly to inform patients of weight gain recommendations during pregnancy and food recommendations.
Workshop No. 1 will provide information on the goals of weight gain during pregnancy, and will target the implementation of recommendations in terms of diet during pregnancy. The messages will be specifically adapted to the population of obese women including dietary advices, work on erroneous beliefs and representations, work on the motivation to change eating habits and reduction of the harmful link between emotions and eating. Thus, beyond the information, this workshop will have the primary role to develop a diet suitable for pregnancy in obese women. This workshop will be led by a dietician and psychologist. It will take place between the 1st and 4th week of the program.
Workshop No. 2 will inform the benefits of breastfeeding for the child and the mother (including its impact on weight loss during the postpartum period, especially important in obese women). As in the previous workshop, the objective will be to obtain the application of the recommendations on diet during breastfeeding. The general message will be adapted to the problems specific to obese women: work on the social, educational, family, removal of beliefs and motivational brakes. This workshop will be led by a dietician and a midwife and will take place between the 5th and 8th week of the program.
Workshop No. 3 will target the diet in the postpartum period and nutritional needs of the newborn and young child. Beyond dietary information, specific work will be done on motivation to take care of the body after pregnancy and breastfeeding, and especially the fight against the beliefs of the food needs of the newborn, typically found in obese mothers (fear of missing, hunger equated with suffering, the emotional power as substitute) This workshop will take place between the 9th and 12th week of the program and will be led by a dietician and a pediatric nurse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Overweight and obese pregnant women
- •Age from 18 to 45 years old
- •Singleton pregnancy between 12+0 to 22+6 weeks of pregnancy
排除标准
- •History of more than 2 miscarriages
- •Severe heart disease (arrhythmias, history of myocardial infarction)
- •Multiple pregnancy
- •Unstable thyroid disease
- •Uncontrolled hypertension
- •Pre-gestational diabetes
- •Bariatric surgery
- •Any medical condition that may interfere with physical activity during pregnancy
- •Minor or absence of health insurance
- •Trusteeship or tutorship
- •Refusal to participate in research
研究组 & 干预措施
participant
agree to participate to the program combining physical activity and nutritional counseling
干预措施: physical activity and nutritional counseling (Behavioral)
no participant
disagree to participate to the program
结局指标
主要结局
Number of participant that will participate to the program
时间窗: at 36 weeks of gestation (WG)
次要结局
- Macrosomia / Birth weight(at birth)
- Gestational weight gain(at birth)
- Pregnancy complications(between 28 weeks of gestation and term)
- Number of patients with C-section or an instrumental extraction(at birth)
- eating behavior before, during and after the program(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum)
- Questionnaire of physical activity(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum)
- Questionnaire for self-esteem(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum)
- number of neonates with neonatal trauma(at birth)
- Apgar score(at birth)
- Arterial umbilical pH(at birth)
- number of neonates with hyperbilirubinemia(Within 7 days after birth)
- Number of neonates needing intensive care transfer(Within 7 days after birth)
- Neonatal adiposity(at birth)
- duration of Breastfeeding(within 6-8 weeks post-partum)
- Maternal Plasmatic cholesterol levels before, during and after the program(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth)
- Maternal Plasmatic leptin levels(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth)
- maternal plasmatic glycemic levels(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth)
- microRNA levels in maternal milk(2 or 3 days after birth)
- Physical activity measured with accelerometers(between 32 and 34 Weeks of gestation and within 6-8 weeks post-partum)
- Maternal Plasmatic triglyceride levels before, during and after the program(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth)
- Maternal Plasmatic Apolipoprotein levels before, during and after the program(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth)
- Maternal plasmatic apelin levels(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth)
- maternal plasmatic insulin levels(between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth)
- Maternal weight(within 6-8 weeks post-partum)
- Infant weight(within 6-8 weeks post-partum)
- Pittsburgh Sleep Quality Index(during 7 days between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum)