E66.8
Conditions
Interventions
Group 1: intervention:
The intervention is a combination of specific physical activity training (46 units, each 90 minutes) and nutrition counselling (6 units, each 60 minutes) over a period of 8 mont
Sponsors
Marga und Walter Boll-Stiftung
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: female, pregnant (25 kg/m2, ability to speak german, no contraindication for physical activity during pregnancy according to ACOG 2015, no drug use which influences body weight, previously inactive, written consent for participation and blood collection
Exclusion criteria
Exclusion criteria: 10. week of gestation, multiple pregnancy, not speaking german sufficiently, contraindication for physical activity during pregnancy according to ACOG 2015, drug use which influences body weight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rapid weight gain during the first month of life seems to be a predicator of overweight and obesity in adulthood. Therefore, primary outcome of this study is the BMI of the child after two years, assessed by German percentile (Kromeyer-Hauschild et al. 2001).childrens BMI after two years, calculated by kg/m2 and classified according to German percentiles for children (Kromeyer-Hauschild et al. 2001) According to Robert-Koch-Institute, normal weight gain (50th percentile) after subtraction of birth weight is nine kilogram at the age of 24 month. BMI (body weight divided by the square of height in meters) shows a difference of 1 kg/m2 at this time point (50th percentile). Therefore, a difference of 1 kg/m2 at the age of two years between intervention and control group will be assumed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be assessed during pregnancy and post partum and will include: - Course of pregnancy (weight gain according to IOM recommendation, avoidance of pregnancy-induced diseases and comorbidities, mode of delivery) - Anthropometric data and health status of new-born (birth weight, length, head circumference, pH Value, Apgar score) - Fetal biomarker of cord blood (insulin, leptin, adiponectin, resistin, BDNF, TNF alpha, IL-6) - Maternal biomarker (insulin, leptin, adiponectin, resistin, BDNF, TNF alpha, IL-6) during and after pregnancy - 8th, 14th, 24th, 36th week of gestation and after intervention (labor, 8 weeks post partum, 12 month post partum, 24 month postpartum) - Paternal biomarker (insulin, leptin, adiponectin, resistin, BDNF, TNF alpha, IL-6) - 8th week of women’s gestation and after intervention (8 weeks post partum, 24 month post partum) - Child development (age appropriate development of fine and gross motor skills, communication, personal-social skills unsing ASQ-3) at 6 month, 12 month, 18 month, 24 month | — |
Countries
Germany
Contacts
Public ContactNina Ferrari
Kölner Zentrum für Prävention im Kindes- und Jugendalter am Herzzentrum der Uniklinik Köln
Outcome results
None listed