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.
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.
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 examinations of
gestational development, foetal and child growth and development will
take place at Copenhagen University Hospital Herlev. 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
390 children will be included in a prospective cohort according to
maternal randomization and examined six times from delivery until the
age of nine years.
In addition to support given from the
Copenhagen University Hospital Herlev financial support has been
obtained from the Danish Dairy Research Foundation and 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). 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.