NCT01894139Active, not recruiting
An Optimized Programming of Healthy Children (APPROACH)
An Optimized Programming of Healthy Children (APPROACH) - The Most Favourable Dietary Protein:Carbohydrate Ratio During Pregnancy in the Context of New Nordic Diet
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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 aim of APPROACH is to investigate how an optimal diet during pregnancy influences the programming of the offspring. The children will after birth be included in a prospective cohort according to maternal randomization and examined six times from delivery until the age of nine years.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 280 (actual)
- First submitted
- 3 Jul 2013
- Start date
- 4 Jan 2014
- Primary completion date
- Jan 2018
- Lead sponsor
- University of Copenhagen
- Diseases
- Obesity
- NCT number
- NCT01894139
What you commit to
- Study type: Interventional
- Participants enrolled: 280
- From 4 Jan 2014 to the primary completion date, Jan 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abuse of alcohol or drugs (\>14 units of alcohol per week)
Other illness
- History of spontaneous abortions or gestational diabetes or preeclampsia or spontaneous preterm birth
- Dairy product intolerant or allergic
- 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.
Other
- Multiple pregnancy
- \> 10 kg weight change during the past year
Who the study is looking for
- 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
Age in the registry: 18 years to 42 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Copenhagen, Faculty of Sceience, NEXS Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.