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ID
Source
Brief title
Health condition
n.a.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gestational weight gain
Secondary outcome
• Postpartum weight retention,
• Smoking cessation
• Dietary habits: 7 day food diary, Three Factor Eating Questionnaire (TFEQ)
• Physical activity habits: accelerometry, Baecke questionnaire
• Miscarriage: defined as the loss of the fetus before the 20th week of pregnancy.
• Pregnancy complications
• Vitamin D status:
• Childbirth complications
• Dysmaturity and macrosomia
• Prematurity
• Metabolic derangement: blood glucose levels, insulin resistance (HOMA-IR), lipid profile and liver enzymes, OGTT .
• Cardiovascular alterations: blood pressure (BP) and pulse wave velocity (PWV), arteriovenous ratio (AV-ratio) derived from retina image.
• Microbial flora of the mother(fecal, vaginal, oral) and child (fecal)
• Epigenetics (biopsy placenta)
• Cord blood glucose, insulin and lipids
• Metabolic derangement of the child: bloodglucose, insulin levels and lipid profile of the infants at 1y.
• Breast milk composition
• Body composition (deuterium method)
• Marital status;
• Education;
• Medical history;
• Number of previous pregnancies;
• Previouw perinatal complications;
• Smoking: pack years.
Background summary
Rationale: The negative perinatal consequences of obesity and smoking during and after pregnancy for mothers and children are significant. Examples of these negative consequences are a higher risk of dysmaturity, prematurity, gestational diabetes mellitus, pregnancy induced hypertension and caesarean delivery. Furthermore, the offspring has a higher chance of developing asthma, obesity and metabolic abberations in childhood, carrying adulthood. Therefore, it is important to break the vicious circle of transferring harmful lifestyle influences from generation to generation.
Objective: The overall aim of this non-randomized intervention study is to evaluate the effects of a lifestyle intervention for young women starting early in pregnancy (≤ 12 weeks of gestational age) and have a high risk on perinatal morbidity because of prepregnancy overweight or obesity and, if applicable, smoking on weight, lifestyle habits, perinatal morbidity, maternal body composition, epigenetics, breast milk composition, metabolic and cardiovascular markers in mother and child, microbial flora of mother and child and lung function of the child.
Intervention: The intervention an integral and multidisciplinary lifestyle intervention consisting of a healthy diet, appropriate physical activity and, if applicable, smoking cessation, customised to the needs of the women.
Main study parameters/endpoints: Primary study parameter is gestational weight gain within the guidelines of the Institute of Medicine. Secondary study parameters are gestational weight gain, postpartum weight retention, smoking cessation, pregnancy and delivery complications. Associations will be determined between gestational weight gain and metabolic and cardiovascular markers in mother and child, maternal body composition, breast milk composition, microbial flora of mother and child, epigenetics and lung function of the child.
Study objective
Via the support of healthy lifestyle in the intervention group, the hypothesis is that more women will have a GWG according the guidelines of the Institute of Medicine (IOM) compared to the control group. It is expected that limited GWG will have beneficial health effects for both the women and their children.
Study design
12, 20, 26, 32, 36 and 40 weeks of pregnancy, 6 weeks postpartum, 3, 6, 9 and 12 months postpartum
Intervention
personalized lifestyle intervention
Inclusion criteria
• Pregnant women (gestational age ≤ 12 weeks)
• Age 18-40 years
• Prepregnancy overweight/obesity (BMI ≥ 25.0 kg/m2). Self-reported prepregnancy weight and measured height at baseline will be used to calculate prepregnancy BMI.
Exclusion criteria
• Haemodynamically significant heart disease;
• Restrictive lung disease;
• Congenital metabolic disease;
• Mentally retarded;
• Bariatric surgery;
• Diabetes type II, dependent on medicine.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9456 |
| Other | METC azM/UM : METC172027 |