Clinical trial

An Optimized Programming of Healthy Children (APPROACH)

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT01894139

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 42 Years

SexFemale

Healthy volunteersAccepted

ConditionPregnancy, Obesity, Gestational Age and Weight Conditions, Maternal Care for Excessive Fetal Growth, Metabolic Disorders

Full registry criteria

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.

Treatments and study arms

High-Protein/Low-GI Diet

Other

Low-protein/High-GI Diet

Other

Primary outcomes

Gestational weight gainGestational 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Copenhagen, Faculty of Sceience, NEXS🇩🇰 Copenhagen, Frederiksberg, Denmark

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