Obesity during pregnancy Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent 2. Pregnant women with booking body mass index (BMI) greater than or equal to 30 kg/m^2 3. Singleton pregnancy
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 06/06/2012: 1. Unwilling or unable to give informed consent 2. Pregnant women with booking BMI less than 30 kg/m^2 3. Multiple pregnancy 4. Pre-existing diabetes mellitus 5. Pre-existing hypertension requiring treatment, pre-existing thyroid and renal disease, current psychosis, sickle cell disease, thalassemia, coeliac disease Previous exclusion criteria: 1. Unwilling or unable to give informed consent 2. Pregnant women with booking BMI less than 30 kg/m^2 3. Multiple pregnancy 4. Pre-existing diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure(s): 1. Maternal: GDM by HAPO criteria. 2. Infant: macrosomia (>90th customised birthweight centile). Previous primary outcome measure(s): Improved maternal glucose sensitivity, assessed at recruitment (10 - 16 weeks), and again in the third trimester (32 - 36 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure(s): 1. Maternal: complications in pregnancy (inc GDM, pre-eclampsia, depression, quality of life), physical activity, diet, gestational weight gain, maternal body composition (skin folds), mode of delivery, hospital admissions. Health economic assessment. 2. Infant: adverse outcomes, neonatal unit admissions, SGA, LGA, body composition (skin folds). 3. At 6 months post partum: maternal and child diet and physical activity. Maternal general health (inc depression, quality of life). Maternal and child body composition. Childhood modifiers/modulators of obesity. 4. 3 years: To be confirmed; measures of maternal and child body composition, diet, physical activity. Childhood mental health, cardiovascular function. Previous secondary outcome measure(s): Reduction in foetal, maternal and pregnancy complications, assessed at recruitment (10 - 16 weeks), and again in the third trimester (32 - 36 weeks). | — |
Countries
England, United Kingdom