Elsje C Oostingh1, Maria P H Koster1, Matthijs R van Dijk1, Sten P Willemsen2, Frank J M Broekmans3, Annemieke Hoek4, Marriëte Goddijn5, Nicole F Klijn6, Evert J P van Santbrink7, Eric A P Steegers1, Joop S E Laven1, Régine P M Steegers-Theunissen8. 1. Department of Obstetrics and Gynecology, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands. 2. Department of Obstetrics and Gynecology, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands; Department of Biostatistics, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands. 3. Division of Reproductive Medicine, Department of Obstetrics and Gynecology, University Medical Center, Utrecht, the Netherlands. 4. University of Groningen, Department of Obstetrics and Gynecology, University Medical Center, Groningen, the Netherlands. 5. Center for Reproductive Medicine, Department of Obstetrics and Gynecology, University Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 6. Division of Reproductive Medicine, Department of Obstetrics and Gynecology, University Medical Center, Leiden, the Netherlands. 7. Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Reinier de Graaf Gasthuis, Delft, the Netherlands. 8. Department of Obstetrics and Gynecology, Erasmus Medical Center, University Medical Center, Rotterdam, the Netherlands. Electronic address: r.steegers@erasmusmc.nl.
Abstract
OBJECTIVE: To study compliance and effectiveness of the mHealth nutrition and lifestyle coaching program Smarter Pregnancy in couples undergoing in vitro fertilization (IVF) treatment with or without intracytoplasmic sperm injection (ICSI). DESIGN: Multicenter, single-blinded, randomized controlled trial, conducted from July 2014 to March 2017. SETTING: IVF clinics. PATIENT(S): A total of 626 women undergoing IVF treatment with or without ICSI and 222 male partners. INTERVENTIONS(S): Couples were randomly assigned to the light (control group) or regular (intervention group) Smarter Pregnancy program. Both groups filled out a baseline screening questionnaire on nutrition and lifestyle behaviors, and the intervention group received coaching tailored to inadequate behaviors during the 24-week period. MAIN OUTCOME MEASURE(S): Difference in improvement of a composite dietary and lifestyle risk score for the intake of vegetables, fruits, folic acid supplements, smoking, and alcohol use after 24 weeks of the program. RESULT(S): Compared with control subjects, women and men in the intervention group showed a significantly larger improvement of inadequate nutrition behaviors after 24 weeks of coaching. At the same time, the women also showed a significantly larger improvement of inadequate lifestyle behaviors. CONCLUSION(S): The mHealth coaching program Smarter Pregnancy is effective and improves the most important nutritional and lifestyle behaviors among couples undergoing IVF/ICSI treatment. International multicenter randomized trials are recommended to study the effect of using Smarter Pregnancy on pregnancy, live birth, and neonatal outcome. NETHERLANDS TRIAL REGISTER NUMBER: NTR4150.
RCT Entities:
OBJECTIVE: To study compliance and effectiveness of the mHealth nutrition and lifestyle coaching program Smarter Pregnancy in couples undergoing in vitro fertilization (IVF) treatment with or without intracytoplasmic sperm injection (ICSI). DESIGN: Multicenter, single-blinded, randomized controlled trial, conducted from July 2014 to March 2017. SETTING:IVF clinics. PATIENT(S): A total of 626 women undergoing IVF treatment with or without ICSI and 222 male partners. INTERVENTIONS(S): Couples were randomly assigned to the light (control group) or regular (intervention group) Smarter Pregnancy program. Both groups filled out a baseline screening questionnaire on nutrition and lifestyle behaviors, and the intervention group received coaching tailored to inadequate behaviors during the 24-week period. MAIN OUTCOME MEASURE(S): Difference in improvement of a composite dietary and lifestyle risk score for the intake of vegetables, fruits, folic acid supplements, smoking, and alcohol use after 24 weeks of the program. RESULT(S): Compared with control subjects, women and men in the intervention group showed a significantly larger improvement of inadequate nutrition behaviors after 24 weeks of coaching. At the same time, the women also showed a significantly larger improvement of inadequate lifestyle behaviors. CONCLUSION(S): The mHealth coaching program Smarter Pregnancy is effective and improves the most important nutritional and lifestyle behaviors among couples undergoing IVF/ICSI treatment. International multicenter randomized trials are recommended to study the effect of using Smarter Pregnancy on pregnancy, live birth, and neonatal outcome. NETHERLANDS TRIAL REGISTER NUMBER: NTR4150.
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