@article{886db2d001644d0abdf83b1a6ee5248b,
title = "Healthy living in pregnancy: A cluster-randomized controlled trial to prevent excessive gestational weight gain - rationale and design of the GeliS study",
abstract = "Background: Recent studies suggest that excessive gestational weight gain (GWG) leads to adverse maternal and fetal outcomes including weight retention in the mother and an increased risk of childhood obesity in the offspring.The aim of the GeliS study is to examine the effect of a lifestyle intervention programme during pregnancy to avoid excessive GWG and, hence, to reduce pregnancy and obstetric complications as well as the risk of maternal and offspring obesity.Methods and design: The GeliS study is a multicentre cluster-randomized controlled trial. A total number of 2500 pregnant women (singleton pregnancy) with a pre-pregnancy BMI ≥ 18.5 kg/m2 and ≤ 40 kg/m2 will be recruited in practices of gynaecologists and midwives in ten Bavarian regions. The intervention comprises three structured and individualised counselling sessions on a healthy diet, regular physical activity as well as weight monitoring during pregnancy and one session after delivery, respectively. The counselling sessions are attached to routine pre- and postnatal visits using standardised materials and procedures. In the control regions, general recommendations for a healthy lifestyle are given. An oral glucose tolerance test is offered to all participants.The primary outcome is the proportion of participants with excessive GWG. Secondary outcomes include pregnancy and obstetric complications such as frequency of gestational diabetes, preeclampsia and caesarean sections as well as weight retention in the mothers and BMI and other health variables in the offspring. A 5-year follow-up of both mothers and their infants is planned.Discussion: The GeliS lifestyle intervention programme has been adapted to the existing routine health care system for pregnant women. If shown to be effective, it could be immediately implemented in routine care.Trial registration: The study protocol is registered at the ClinicalTrials.gov Protocol Registration System (NCT01958307).",
keywords = "Childhood obesity, Diet, Exercise, Gestational diabetes, Gestational weight gain (GWG), Lifestyle intervention, Obesity prevention, Pregnancy, Weight retention",
author = "Kathrin Rauh and Julia Kunath and Eva Rosenfeld and Luzia Kick and Kurt Ulm and Hans Hauner",
note = "Funding Information: All practice-based gynaecologists including their medical staff as well as all midwives in the selected regions are contacted via information leaflets and by phone. Participating gynaecologists, medical staff or midwives will act as local health care providers and key communicators by implementing counselling sessions for participating pregnant women in the “real-life” setting of routine care. They have to attend a standardised qualifying seminar to ensure competency in lifestyle counselling and standardisation of the intervention. Seminar and information material for the counsellors as well as for the pregnant women were developed in cooperation with the network “Healthy Start - Young Family Network”, a project of IN FORM, which is funded by the German Federal Ministry of Food and Agriculture [48]. Funding Information: The study is funded by the Else Kr{\"o}ner-Fresenius Centre for Nutritional Medicine at the Technische Universit{\"a}t M{\"u}nchen, the Competence Centre for Nutrition (KErn) in Bavaria, the Bavarian State Ministry of Food, Agriculture and Forestry, the Bavarian State Ministry of Health and Care (Health Initiative “Gesund.Leben.Bayern.”), as well as AOK Bayern, the largest statuatory health insurance in Bavaria. We gratefully acknowledge the valuable contribution from the network “Healthy Start - Young Family Network”, a project of IN FORM (Maria Flothk{\"o}tter, Katharina Kr{\"u}ger, Julia Bonfig), funded by the German Federal Ministry of Food and Agriculture, Bonn, and the M{\"u}nchner Studienzentrum at Technische Universit{\"a}t M{\"u}nchen (Dr. Alfred Zollner, Dr. Elisabeth Andr{\'e}, Caspar Sennefelder). Project managers at the expert centres for nutrition/community catering at the regional offices (AELF) of the Bavarian State Ministry of Food, Agriculture and Forestry (StMELF) are coordinating the study in the ten study regions. Finally, the input from Dr. Uta Engels, Sports Centre, University of Regensburg, Prof. Karl-Heinz Ladwig, Institute of Epidemiology, Helmholtz Zentrum M{\"u}nchen, Prof. K.T.M. Schneider, Division of Obstetrics and Perinatal Medicine, Technische Universit{\"a}t M{\"u}nchen, and Gabi Pfeifer, sports scientist at KErn, is gratefully acknowledged. We are also indebted to the Board of Trustees: Maria Flothk{\"o}tter, aid infodienst Ern{\"a}hrung, Landwirtschaft, Verbraucherschutz e.V., Bonn; Dr. Beatrix Heilig, Bavarian State Ministry of Health and Care; Marion Kratzmair, Bavarian State Ministry of Food, Agriculture and Forestry; Dr. Wolfram Schaecke, Competence Centre for Nutrition, Freising/Kulmbach, and Dr. Annette Scheder, AOK Bayern. We would also like to thank the Bayerische Landes{\"a}rztekammer, Bayerischer Hebammen Landesverband e.V. and the Company Beurer GmbH, Ulm, for supporting activities as well as Dr. Lynne Cresswell for critical reading of the manuscript. This work was supported by the German Research Foundation (DFG) and the Technische Universit{\"a}t M{\"u}nchen within the funding programme Open Access Publishing.",
year = "2014",
month = mar,
day = "28",
doi = "10.1186/1471-2393-14-119",
language = "English",
volume = "14",
journal = "BMC Pregnancy and Childbirth",
issn = "1471-2393",
publisher = "BioMed Central Ltd.",
number = "1",
}
