An Optimized Programming of Healthy Children (APPROACH)
|ClinicalTrials.gov Identifier: NCT01894139|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : August 17, 2017
|Condition or disease||Intervention/treatment|
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2025|
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.
|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.
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894139
|Copenhagen University Hospital at Herlev (EFFECT)|
|Herlev, Denmark, 2730|
|Principal Investigator:||Arne V Astrup, Professor||Copenhagen University Hospital at Herlev (EFFECT)|