Overweight and excessive gestational weight gain (GWG) is associated
with increased risk of high birth weight; furthermore, there is an
increased risk of the child developing overweight, diabetes and other
metabolic diseases in childhood or adulthood. Increased knowledge to the
possibility and efficacy of preventing overweight and related diseases
is necessary. The effect of reducing GWG while supplying optimized
amount and sources of nutrients is not well investigated. 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 foetal body
composition, metabolism and weight control later in life, and less
weight gain and weight retention for the mother.
APPROACH is a dietary intervention investigating differences in response to a high-protein, especially marine and dairy protein, and with meat from pork over other sources, and low-GI diet versus a diet according to the Nordic Nutritional Recommendations. All visits and assessment are performed by trained staff at Copenhagen University Hospital Herlev-Gentofte and Department of Nutrition, Exercise and Sports, University of Copenhagen. Subjects are women with expected delivery at Department of Gynaecology and Obstetrics, Herlev Hospital. Examinations of gestational development will take place at Herlev Hospital Herlev, and foetal and child growth and development at Department of Nutrition, Exercise and Sports. 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 all children will be included in a prospective cohort according to maternal randomization and examined six times from delivery until the age of nine years.
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 of age, risk markers later metabolic
diseases, especially diabetes and metabolic syndrome.
In addition to support given from the Copenhagen University Hospital Herlev financial support has been obtained from the Danish Pig Meat Association, Danish Dairy Research Foundation, OPUS project - Optimal well-being, development, and health for Danish children through a healthy New Nordic Diet (supported by a grant from the Nordea Foundation), and Danish Agriculture and Food Counsel. Furthermore support has been granted from LEGO Charity, Pharma Nord and PharmoVital.
APPROACH is registered on www.clinicaltrials.gov identified as NCT01894139, by 31st
October 2013 approved by the Ethical Committee, journal number:
H-3-2013-119 and declared to the Danish data protection agency, journal
number is HEH-2013-046 / 02414.