An Optimized Programming of Healthy Children (APPROACH)

Not Applicable

Active, not recruiting

• Conditions: Pregnancy; Gestational Age and Weight Conditions; Obesity; Metabolic Disorders; Maternal Care for Excessive Fetal Growth
• Interventions: Other: High-Protein/Low-GI Diet; Other: Low-protein/High-GI Diet

• Registration Number: NCT01894139
• Lead Sponsor: University of Copenhagen

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) ≥ 30 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.

Study Timeline

• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Study Start: 2014-01-04
• Primary Completion: 2018-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-protein/Low-GI Diet	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.
Low-protein/High-GI Diet	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.

Primary Outcome Measures

Name	Time	Method
Gestational weight gain	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.

Secondary Outcome Measures

Name	Time	Method
Growth and development of fetus and child	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 in meter, weight in kilograms, body composition (Bioimpedance (month 6,18) and Dual-energy X-ray absorptiometry, DXA (month 0, 36, year 5, 9) , and Magnetic Resonance Imaging (year 9)), skin fold thickness and mid-upper arm circumference, IGF-1.
Fetal programming of obesity and metabolic disorders	Month 0, 6,18, 36 and year 5, 9	Fasting blood samples (month 0 from umbilical cord), not at 6 months and 18 months; continuous glucose monitoring (year 9) in mmol/L; dietary intake, physical activity, growth and development.

Trial Locations

Locations (1)

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