Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 8, 2021
Date Accepted: Jun 14, 2021
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Optimizing periconception lifestyle of overweight women using a blended personalized care intervention combining eHealth and Face-to-face coUnSEling: The Randomized Controlled eFUSE Trial
ABSTRACT
Background:
Maternal overweight has a significant impact on reproductive, maternal, pregnancy and neonatal outcome with long-term and transgenerational health consequences. Interventions that aim to optimize periconception maternal lifestyle can improve maternal and fetal health during pregnancy and throughout the life course. However, it remains very difficult to change and adopt adequate lifestyle behaviors. We hypothesize that additional psychological therapy targeting cognitive and affective factors substantially contribute to the effectiveness of these interventions.
Objective:
The proposed study aims to examine the feasibility and effectiveness of a blended personalized periconception lifestyle care intervention with additional psychological therapy, aimed at women with a Body Mass Index (BMI) ≥25, who have a childwish or are already pregnant (≤12 weeks), in reducing inadequate lifestyle behaviors, and improve early and late pregnancy outcome.
Methods:
The eFUSE study follows a single-center two-arm randomized controlled trial design at the Erasmus MC, University Medical Center, with multicenter regional referral. The female patients with overweight (BMI ≥25), together with their male partner, will be stratified by pregnancy status (preconception vs. pregnant) and randomized to receive either the blended personalized periconception lifestyle care intervention with additional psychological therapy (n=313) or usual care (n=313). The primary outcome is change in the Lifestyle Risk Score (between baseline and 24 weeks) between the randomization arms (difference in differences). Secondary outcomes include measurements defined as most relevant by International Consortium for Health Outcomes Measurement, including behavioral determinants, patient satisfaction, provider feasibility and maternal pregnancy and neonatal complications.
Results:
The study will be opened for recruitment from July 2021 onward. Data collection is expected to be completed by December 2022, and the results are expected to be published by June 2023.
Conclusions:
This study will evaluate the feasibility and effectiveness of a blended periconception lifestyle intervention with additional psychological therapy, aimed at women with a BMI ≥25. Positive results of this innovative care approach will be used for implementation in routine medical care of all overweight women, with the ultimate aim to improve clinical outcomes of these high risk pregnancies. Clinical Trial: NL9264 (www.trialregister.nl)
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