title: The use of the mHealth program Smarter Pregnancy in preconception care: rationale, study design and data collection of a randomized controlled trial.
abstract: Unhealthy nutrition and lifestyle contribute to the worldwide rising prevalence of non-communicable diseases. This also accounts for the reproductive population, in which unhealthy behavior affects fertility and pregnancy outcome. Maternal smoking, alcohol consumption and inadequate folic acid supplement use are strongly associated with fetal complications as small for gestational age, premature birth and congenital malformations. In the Netherlands 83% of the perinatal mortality rate is due to these complications and is relatively high compared to other European countries. In order to reduce this prevalence rate, preconception care should be focused on the promotion of health of prospective parents by identification and intervention on modifiable nutrition and lifestyle risk factors. We developed the personal mHealth program 'Smarter Pregnancy' (Dutch version available on: https://www.slimmerzwanger.nl ) to provide individual coaching and information to improve nutrition and lifestyle during the preconception period in order to improve health of the reproductive population and subsequent generations.
  
  
  
  Women between 18 and 45 years of age, and trying to conceive are eligible for inclusion in a randomized controlled trial. Participants are allocated either to a general population cohort or a subfertile (IVF/ICSI) population cohort. The intervention group receives personal online coaching based on the identified nutrition and lifestyle risk factors at baseline. Coaching comprises recipes, incentives, additional questions including feedback and text and e-mail messages, with a maximum of three per week. The control group only receives one recipe per week to maintain adherence to the program and prevent drop out. Screening questionnaires are send in both groups at 6, 12, 18, and 24 weeks of the program to monitor the change in the identified risk factors.
  
  
  
  We expect to demonstrate that the mHealth program 'Smarter Pregnancy' can effectively improve nutrition and lifestyle in couples contemplating pregnancy. By the identification and improvement of modifiable nutrition and lifestyle risk factors on a large scale, both reproductive and pregnancy outcomes can be improved and subsequent perinatal morbidity and mortality rates are expected to be reduced. The current use and rapid development of mHealth applications offers new opportunities to reach and educate large populations, which can facilitate the implementation of preconception care.
  
  
  
  Dutch trial register: NTR4150 . (Registered 19thAugust 2013).
authors.affiliation: Department of Obstetrics and Gynecology, Erasmus MC, University Medical Centre Rotterdam, PO Box 2040, Rotterdam, 3000CA, The Netherlands.
authors.forename: Matthijs R
authors.initials: MR
authors.lastname: van Dijk
authors.affiliation: Department of Obstetrics and Gynecology, Erasmus MC, University Medical Centre Rotterdam, PO Box 2040, Rotterdam, 3000CA, The Netherlands.
authors.forename: Elsje C
authors.initials: EC
authors.lastname: Oostingh
authors.affiliation: Department of Obstetrics and Gynecology, Erasmus MC, University Medical Centre Rotterdam, PO Box 2040, Rotterdam, 3000CA, The Netherlands.
authors.forename: Maria P H
authors.initials: MP
authors.lastname: Koster
authors.affiliation: Department of Biostatistics, Erasmus MC, University Medical Centre Rotterdam, PO Box 2040, Rotterdam, 3000CA, The Netherlands.
authors.forename: Sten P
authors.initials: SP
authors.lastname: Willemsen
authors.affiliation: Department of Obstetrics and Gynecology, Erasmus MC, University Medical Centre Rotterdam, PO Box 2040, Rotterdam, 3000CA, The Netherlands.
authors.forename: Joop S E
authors.initials: JS
authors.lastname: Laven
authors.affiliation: Department of Obstetrics and Gynecology, Erasmus MC, University Medical Centre Rotterdam, PO Box 2040, Rotterdam, 3000CA, The Netherlands. r.steegers@erasmusmc.nl.|Department of Pediatrics, Division of Neonatology, Erasmus MC, University Medical Centre Rotterdam, PO Box 2040, Rotterdam, 3000CA, The Netherlands. r.steegers@erasmusmc.nl.
authors.forename: Régine P M
authors.identifier: 0000-0002-4353-5756
authors.initials: RP
authors.lastname: Steegers-Theunissen
mesh_terms: D000293:Adolescent; D000328:Adult; D034742:Electronic Mail; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D016742:Preconception Care / Q000379:methods*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011295:Prenatal Care / Q000379:methods*; D015397:Program Evaluation; D011446:Prospective Studies; D017216:Telemedicine / Q000706:statistics & numerical data*; D055815:Young Adult
keywords: Fertility; Lifestyle; Nutrition; Pregnancy complications; Pregnancy outcome; Reproductive outcome