Clinical trial NCT01894139: An Optimized Programming of Healthy Children (APPROACH)
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy
Obesity
Gestational Age and Weight Conditions
Maternal Care for Excessive Fetal Growth
Metabolic Disorders
Keywords: Gestational weight gain
Obese women
Fetal programming
Metabolic disorders
Development of obesity
Development og overweight
Complications during pregnancy and birth
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Dairy Research Foundation, Denmark
name: Nordea-Fonden, Denmark
name: LEGO Charity, Denmark
name: Pharma Nord
name: Danish Agriculture and Food Council
name: Danish Pork Levy Foundation
name: The Novo Nordic Foundation
First posted: 2013-07-10
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 other metabolic diseases in childhood or adulthood. The effect of reducing gestational weight gain while supplying optimized amount and sources of nutrients is not well investigated. Increased knowledge to the possibility and efficacy of preventing overweight and related diseases is necessary. Modification of protein source and increase in ratio of protein in relation to amount of carbohydrate and reduction of glycaemic index (GI) has in observational studies individually been linked to improved fetal body composition, metabolism and weight control later in life, and less weight gain and weight retention for the mother. The overall aim of APPROACH is to investigate how an optimal diet during pregnancy influences the programming of the offspring. This study will increase the knowledge of the effect of a specific nutrient composition and weight retention during pregnancy on growth and development during the foetal stage and until nine years off age, risk markers later metabolic diseases, especially diabetes and metabolic syndrome. APPROACH will be a dietary intervention investigating differences in responds to a high-protein, especially marine and dairy protein and low-GI diet versus a diet according to the Nordic Nutritional Recommendations. All visits and assessment will be performed by trained staff at Copenhagen University Hospital Herlev. Subjects will be women with expected delivery at Department of Gynaecology and Obstetrics and all examinations of gestational development and foetal growth will take place her; assessment of the children will be performed at the Department of Paediatrics. A total of 390 obese (body mass index (BMI) ≥ 28 kg/m2) pregnant women will be randomized to intervention or control and engage in the program from late first trimester or early second trimester to birth. After birth the children will be included in a prospective cohort according to maternal randomization and examined six times from delivery until the age of nine years. APPROACH will increase the knowledge of the effect of a nutrient composition with high protein for carbohydrate ratio and weight retention during pregnancy on growth and development during the foetal stage and until nine years off age, risk markers later metabolic diseases, especially diabetes and metabolic syndrome. Plasma lipids, markers of metabolic diseases, epigenetics and vitamin D status will be assessed at baseline and several times during pregnancy; and in both intervention and control group these data will increase the knowledge of the effect of supplementing with marine oils and vitamin D in pregnant women. Results from the intervention will be communicated to the general population and published in peer-relieved journals.

Eligibility 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.

Primary outcomes:
measure: Gestational weight gain
timeFrame: Gestational week 14, 15, 17, 21, 25, 28, 36, 39
Secondary outcomes:
measure: Growth and development of fetus and child
timeFrame: Gestational week 11+2, 14+0, 28, 32, 36 and month 0, 6, 18, 36 and year 5, 9
measure: Fetal programming of obesity and metabolic disorders
timeFrame: Month 0, 6,18, 36 and year 5, 9
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Faculty of Sceience, NEXS
state: Frederiksberg
Study officials:
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Christian Mølgaard, Professor
role: PRINCIPAL_INVESTIGATOR
References: