This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
76
The investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation.
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Reduction in body weight
Time frame: From baseline to 6 weeks postpartum
Gestational weight gain
Time frame: 6 weeks of gestational age to 36 weeks of gestational age
Postpartum weight retention
Time frame: 6 weeks of gestational age to 6 months postpartum
Smoking cessation
Time frame: Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
Biochemical verification of tobacco use
The amount of carbon monoxice (CO) in exhaled breath will be measured using a CO monitor (piCO Baby Smokerlyzer®, Bedfont, Kent, United Kingdom). Biochemical verification will also be done by measurement of urine cotinine.
Time frame: Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
Dietary habits
By a food diary and the three factor eating questionnaire.
Time frame: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
Physical activity habits
By an accelerometer and the Baecke questionnaire.
Time frame: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
Miscarriage
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Time frame: During pregnancy: at 6, 12 and 20 weeks of gestational age.
Time to pregnancy
Time frame: From pregnancy wish to first day of last menstruation
Pregnancy complications
Gestational diabetes mellitus, pregnancy-induced hypertension, preeclampsia.
Time frame: At birth
Delivery complications
Caesarean section, induction of labour, vacuum extraction, postpartum haemorrhage, maternal hospital stay, shoulder dystocia.
Time frame: At birth
Vitamin D status
Time frame: Will be measured at baseline and at 32 weeks of gestational age.
Dysmaturity and macrosomia
Time frame: At birth
Prematurity
Birth before 37 weeks of gestational age
Time frame: At birth
Fasting glucose level
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Fasting insulin level
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Insuline resistance (HOMA-IR)
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Total cholesterol
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
LDL cholesterol
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
HDL cholesterol
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Triglycerides
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Free fatty acids
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Alkaline phosphatase
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Gamma-GT
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
ASAT
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
ALAT
Time frame: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
Blood pressure
Time frame: Will be measured at baseline; Prepregnancy: after 1, 2, 3, 6, 9 and 12 months; During pregnancy: at 6, 12, 20, 32, 36 and 40 weeks of gestational age; Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
Pulse wave velocity
Time frame: Will be measured at baseline; Prepregnancy: after 3, 6 and 12 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: at 6 and 12 months.
Fat mass and fatt free mass
Body composition will be measured using the deuterium dilution method
Time frame: Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum
Fasting glucose level of the child
Time frame: At birth and 12 months postpartum
Fasting insulin level of the child
Time frame: At birth and 12 months postpartum
Insulin resistance (HOMA-IR) of the child
Time frame: At birth and 12 months postpartum
Total cholesterol of the child
Time frame: At birth and 12 months postpartum
LDL cholesterol of the child
Time frame: At birth and 12 months postpartum
HDL cholesterol of the child
Time frame: At birth and 12 months postpartum
Triglycerides of the child
Time frame: At birth and 12 months postpartum
Free fatty acids of the child
Time frame: At birth and 12 months postpartum
Tidal volume of the child
Time frame: Will be measured at 6 weeks and 12 months postpartum
Respiratory rate of the child
Time frame: Will be measured at 6 weeks and 12 months postpartum
Respiratory system resistance of the child
Time frame: Will be measured at 6 weeks and 12 months postpartum
Respiratory system reactance of the child
Time frame: Will be measured at 6 weeks and 12 months postpartum
Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion acetylcholine
Time frame: Will be measured at 6 weeks and 3 and 12 months postpartum
Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion nitroprusside
Time frame: Will be measured at 6 weeks and 3 and 12 months postpartum