Status:
ACTIVE_NOT_RECRUITING
An Optimized Programming of Healthy Children (APPROACH)
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
The Danish Dairy Research Foundation, Denmark
Nordea-Fonden, Denmark
Conditions:
Pregnancy
Obesity
Eligibility:
FEMALE
18-42 years
Phase:
NA
Brief Summary
The Nutrition Research Unit at Copenhagen University Hospital Herlev will during the fall 2013 initiate a randomized and controlled intervention study engaging 390 obese pregnant women. The overall ai...
Detailed Description
Overweight and excessive gestational weight gain (GWG) is associated with increased risk of high birth weight; furthermore there is increased risk of the child developing overweight, diabetes and othe...
Eligibility Criteria
Inclusion
- Birth planed at Copenhagen University Hospital Herlev
- Pre-pregnancy BMI 28-45
- Age 18-42 years
- Speak and understand oral and written Danish
- Singleton pregnancy
Exclusion
- Multiple pregnancy
- History of spontaneous abortions or gestational diabetes or preeclampsia or spontaneous preterm birth
- Dairy product intolerant or allergic
- \> 10 kg weight change during the past year
- Abuse of alcohol or drugs (\>14 units of alcohol per week)
- Critical or chronic disease: diabetes, kidney disease, medically treated heart diseases or arthritis, sarcoidosis, tuberculosis, cancer, liver disease, inflammatory gastrointestinal or lung disease, known active metabolic disease.
Key Trial Info
Start Date :
January 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT01894139
Start Date
January 4 2014
End Date
December 31 2027
Last Update
September 19 2024
Active Locations (1)
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1
University of Copenhagen, Faculty of Sceience, NEXS
Copenhagen, Frederiksberg, Denmark, 1958