An Optimized Programming of Healthy Children (APPROACH)
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ClinicalTrials.gov Identifier: NCT01894139 |
Recruitment Status :
Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : September 30, 2021
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Condition or disease | Intervention/treatment | Phase |
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Pregnancy Obesity Gestational Age and Weight Conditions Maternal Care for Excessive Fetal Growth Metabolic Disorders | Other: High-Protein/Low-GI Diet Other: Low-protein/High-GI Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 280 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | An Optimized Programming of Healthy Children (APPROACH) - The Most Favourable Dietary Protein:Carbohydrate Ratio During Pregnancy in the Context of New Nordic Diet |
Actual Study Start Date : | January 4, 2014 |
Actual Primary Completion Date : | January 2018 |
Estimated Study Completion Date : | December 2027 |
Arm | Intervention/treatment |
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Experimental: High-protein/Low-GI Diet
High-protein (25-28 E%), especially marine- and dairy-protein (8-10 E%) and low-GI (GI<55) ad libitum Diet in accordance with the principles of palatability and sustainability of the New Nordic Diet.
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Other: High-Protein/Low-GI Diet |
Active Comparator: Low-protein/High-GI Diet
Ad libitum diet based on the Danish National Guidelines (NNR) (protein 10-20 E%; no information on restricting glycaemic load (GI ~ 60)) and in accordance with the principles of palatability and sustainability of the New Nordic Diet.
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Other: Low-protein/High-GI Diet |
- Gestational weight gain [ Time Frame: Gestational week 14, 15, 17, 21, 25, 28, 36, 39 ]Changes in bodyweight, body composition (Magnetic Resonance Imaging) and measurements of body fat by means of skinfold thickness and mid-upper arm circumference.
- Growth and development of fetus and child [ Time Frame: Gestational week 11+2, 14+0, 28, 32, 36 and month 0, 6, 18, 36 and year 5, 9 ]Fetus: Nuchal Translucency Scan (once gw 11+3 - 14+0) and ultrasound scan (gw 28, 32, 36); child: Height, weight, body composition (Bioimpedance (month 6,18)and Dual-energy X-ray absorptiometry, DXA (month 0, 36, year 5, 9)), skin fold thickness and mid-upper arm circumference, IGF-1.
- Fetal programming of obesity and metabolic disorders [ Time Frame: Month 0, 6,18, 36 and year 5, 9 ]Fasting blod samples (month 0 from umbilical cord), not at 6 months; dietary intake, physical activity, growth and development

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Ages Eligible for Study: | 18 Years to 42 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894139
Denmark | |
University of Copenhagen, Faculty of Sceience, NEXS | |
Copenhagen, Frederiksberg, Denmark, 1958 |
Principal Investigator: | Arne V Astrup, Professor | Department of Nutrition, Exercise and sports, University of Copenhagen |
Responsible Party: | Arne Astrup, Head of Research, University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT01894139 |
Other Study ID Numbers: |
EFFECT.C02.2012 |
First Posted: | July 10, 2013 Key Record Dates |
Last Update Posted: | September 30, 2021 |
Last Verified: | September 2021 |
Gestational weight gain Obese women Fetal programming Metabolic disorders |
Development of obesity Development og overweight Complications during pregnancy and birth |
Metabolic Diseases |