Effect of an Educational Intervention for the Prevention and Management of Overweight and Obesity During the First 18 Months of Life Children and Mothers With Gestational Diabetes in Insured of the Instituto Mexicano Del Seguro Social.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 645
- 试验地点
- 2
- 主要终点
- Prevention of overweight/obesity in offspring, determined by z-score in the indicator for weight for age
研究概览
简要总结
In order to evaluate the effect of an educational intervention on mothers with gestational diabetes and their offspring in the first 18 months of life, The intervention will be applied to mothers with gestational diabetes, and a group of mothers without diabetes, against a control group with the normal post-partum treatment. Effects on overweight and obesity will be evaluated in both mothers and offspring.
详细描述
Effect of an education intervention for the prevention and management of overweight and obesity during the first 18 months of life of offspring and mother with gestational diabetes among insured of the Instituto Mexicano del Seguro Social.
ABSTRACT BACKGROUND: According to ENSANUT 2012, 9.7% of children <5 years already are overweight or obese. Recently, an increase was reported in the frequency of overweight and obesity worldwide, beginning at earlier ages, especially in Mexico. The predisposition to chronic diseases in adults may be programmed in the womb ("fetal programming"). Also, women that suffer diabetes during pregnancy have a very high risk (6.4 times more) of developing diabetes in a middle range. The challenge for health personnel dedicated to the care of mother-child pairs is to achieve glycemic control from conception and to identify all the maternal-fetal secondary complications. To carry out compliance with adherence to medical management and/or healthy eating habits would allow us to reduce future overweight, obesity and the incidence of type 2 diabetes in mother-child pairs. Approaching the mother-child pair is a great opportunity to study the intervention, which would allow us not only have a new, useful awareness in the evaluation of educational strategies, but also to apply good practices of healthy habits for the prevention of obesity and to avoid progression to diabetes. For the aforementioned reasons, the objective is: to implement and evaluate the effect of an education intervention for the prevention and management of overweight and obesity during the first 18 months of life of child and in mothers with and without gestational diabetes in insured members of the Instituto Mexicano del Seguro Social.
MATERIAL AND METHODS. Pregnant women will be invited to participate, who receive their prenatal and/or birth care in the Unidad Médica de Alta Especialidad (UMAE) Gineco-Obstretric Hospital No. 4 (HGO #4) and UMAE HGO #3 of Centro Médico "La Raza" of IMSS. After acceptance and signing an informed consent to participate in the study, 645 mother-child pairs will be included, with and without gestational diabetes mellitus (GDM), which will be diagnosed according to the criteria of the American Diabetes Association; all mothers with be between 18 and 40 years old. There will be 3 groups of binomials: 1) with GDM, 2) without GDM who will received the education intervention, and 3) without GDM who will receive the conventional care IMSS offers to mothers and nursing infants, during the first 18 months post-partum.
At the time of canalization before delivery or cesarean, a blood sample (15 mL) will be taken from the mother for measurement of glucose, glucosylated hemoglobin (A1c) and lipid profile. After birth, blood (15 mL) will be extracted directly from the umbilical cord for measurement of the child's glucose and lipid profile. Once the pediatric doctor has carried out reanimation of the newborn, previously-standardized health staff will take anthropometric measurements. During the 18 months of follow-up from birth, the mother-child pair will be given appointments at 0, 1, 2, 3, 6, 9, 12, 15 and 18 months, in which health care personnel involved in the study (nutritionist, social worker, pediatrician and family doctor) will perform activities to promote health and prevent disease, directed towards the mother-child pair and planned within the education intervention strategy based on the First 1000 Days program, or the conventional care that mothers and nursing infants receive in IMSS, according to the study group. Weekly, the mothers will be sent, by digital media and social networks, educational material to promote healthy diet and physical activity; for the child material will include the promotion of exclusive breastfeeding until 6 months, at which time promotion will be of adequate complementary foods, in addition to early stimulation activities; educational material will be handed out: posters and brochures will serve to reinforce and remind of the information given during appointments. Also, characteristics of the diet consumed by mother and child will be recorded monthly, along with the physical activity performed by the mother.
The education intervention has as objective the acquiring of knowledge, motivation, creation of an awareness of disease, adoption of healthy diet and physical activity; its components will be individual sessions, group sessions, electronic messages, etc.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-40 years old
- •insured by IMSS
- •with or without gestational diabetes
排除标准
- •History of type 1 or 2 diabetes, MODY or secondary diabetes
- •CKD, hepatic or cardiac disease, pregnancy hypertension, corioamniotis orpremature membrane rupture, pulmonary maturity 24 hours before birth, severe complications
结局指标
主要结局
Prevention of overweight/obesity in offspring, determined by z-score in the indicator for weight for age
时间窗: 18 months
Offspring will be expected to have a difference of at least 0,3 standard deviations in z-score of the indicator for weight for age, as measured by weight on a standard weight scale over the course of the study, and compared with WHO growth charts.
Prevention of overweight/obesity mothers, determined by loss in body mass index (BMI)
时间窗: 18 months
Mothers will be expected to have a loss of at least 1.8kg/m2 of body mass index (BMI, weight/height squared), as measured by weight, as measured by a standard weight scale, divided by height in meters squared over the course of the study.
次要结局
- Changes in blood concentration of glucose: GDM(18 months)
- Changes in blood concentration of glycosylated hemoglobin: GDM(18 months)
- Changes in blood concentration of lipids: GDM(18 months)
- Changes in blood concentration of lipids: intervention(18 months)
- Changes in blood concentration of glucose: intervention(18 months)
- Changes in blood concentration of glycosylated hemoglobin: intervention(18 months)
研究者
Rita A. Gomez Diaz
Principal Investigator
Instituto Mexicano del Seguro Social
