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Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands
  1. Yvon E G Timmermans1,2,
  2. Kim D G van de Kant1,3,
  3. Dorien Reijnders1,4,
  4. Lina M P Kleijkers1,
  5. Edward Dompeling1,3,
  6. Boris W Kramer1,2,
  7. Luc J I Zimmermann1,2,4,
  8. Régine P M Steegers-Theunissen5,
  9. Marc E A Spaanderman2,6,
  10. Anita C E Vreugdenhil1,4
  1. 1Department of Paediatrics, Maastricht University Medical Centre (MUMC+), Maastricht, Netherlands
  2. 2School for Oncology and Developmental Biology (GROW), Maastricht University, Maastricht, Netherlands
  3. 3School for Public Health and Primary Health Care (CAPHRI), Maastricht University, Maastricht, Netherlands
  4. 4School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, Netherlands
  5. 5Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Center, Rotterdam, Netherlands
  6. 6Department of Gynaecology & Obstetrics, MUMC+, Maastricht, Netherlands
  1. Correspondence to Dr Anita C E Vreugdenhil; a.vreugdenhil{at}mumc.nl

Abstract

Introduction Periconception obesity is associated with a higher risk for adverse perinatal outcomes such as gestational diabetes mellitus, preeclampsia, large for gestational age, operative delivery and preterm birth. Lifestyle interventions during pregnancy have resulted in insufficient effects on reducing these perinatal complications. A few reasons for this disappointing effect can be suggested: (1) the time period during pregnancy for improvement of developmental circumstances is too short; (2) the periconception period in which complications originate is not included; and (3) lifestyle interventions may not have been sufficiently multidisciplinary and customised. A preconception lifestyle intervention might be more effective to reduce perinatal complications. Therefore, the aim of the Towards Prepared mums study is to evaluate the effect of a lifestyle intervention starting prior to conception on lifestyle behaviour change.

Methods and analysis This protocol outlines a non-blinded, randomised controlled trial. One hundred and twelve women (18–40 years of age) with overweight or obesity (body mass index≥25.0 kg/m2) who plan to conceive within 1 year will be randomised to either the intervention or care as usual group. The intervention group will receive a multidisciplinary, customised lifestyle intervention stimulating physical activity, a healthy diet and smoking cessation, if applicable. The lifestyle intervention and monitoring will take place until 12 months postpartum. The primary outcome is difference in weight in kg from baseline to 6 weeks postpartum. Secondary outcomes are gestational weight gain, postpartum weight retention, smoking cessation, dietary and physical activity habits. Furthermore, exploratory outcomes include body composition, cardiometabolic alterations, time to pregnancy, need for assisted reproductive technologies, perinatal complications of mother and child, and lung function of the child. Vaginal and oral swabs, samples of faeces, breast milk, placenta and cord blood will be stored for evaluation of microbial flora, epigenetic markers and breast milk composition. Furthermore, a cost-effectiveness analysis will take place.

Ethics and dissemination Ethical approval was obtained from the Medical Ethical Committee of Maastricht University Medical Centre+ (NL52452.068.15/METC152026). Knowledge derived from this study will be made available by publications in international peer-reviewed scientific journals and will be presented at (inter)national scientific conferences. A dissemination plan for regional and national implementation of the intervention is developed.

Trial registration number ClinicalTrials.gov NCT02703753.

  • preventive medicine
  • perinatology
  • maternal medicine
  • fetal medicine

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors Study concept and design: YEGT, KDGvdK, MEAS, ED, LJIZ, RPMS-T, BWK and ACEV. Acquisition of data: YEGT and LMPK. Draft of manuscript and statistical analysis: YEGT, KDGvdK, LMPK and ACEV. Revision content of manuscript: YEGT, DR, KDGvdK, MEAS, ED, RPMS-T, LJIZ, BWK and ACEV. All authors read and approved the manuscript for final publication. ACEV has the primary responsibility for the final content.

  • Funding This study is partly funded by Maastricht UMC+ (PI-00231). Other parts of the study are covered by The Netherlands Organisation for Health Research and Development (project number 524005516), and the Christine Bader Foundation Irene Child Hospital (project number 546).

  • Competing interests RPMS-T is initiator and developer of Smarter Pregnancy and does not have a commercial interest. The Department of Obstetrics and Gynaecology of the Erasmus MC, University Medical Centre in Rotterdam is owner of this mHealth coaching tool.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.