Abstract
BackgroundMaternal overweight has a substantial impact on reproductive, maternal, pregnancy, and neonatal outcomes 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 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.ObjectiveThe 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 BMI≥25 and who are contemplating pregnancy or are already pregnant (≤12 weeks) in reducing inadequate lifestyle behaviors and improving early and late pregnancy outcome.MethodsThe eHealth and Face-to-face Counseling (eFUSE) study follows a single-center two-arm randomized controlled trial design at the Erasmus MC, University Medical Center, with a 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 a 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 the International Consortium for Health Outcomes Measurement, including behavioral determinants, patient satisfaction, provider feasibility, and maternal pregnancy and neonatal complications.ResultsThe study will be open for recruitment from Fall 2021 onward. Data collection is expected to be completed by the beginning of 2023, and the results are expected to be published by Fall 2023.ConclusionsThis 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 women with overweight, with the ultimate aim to improve clinical outcomes of these high-risk pregnancies.Trial RegistrationNetherlands Trial Register NL9264; https://www.trialregister.nl/trial/9264International Registered Report Identifier (IRRID)PRR1-10.2196/28600
Highlights
MethodsOverweight is still a pressing health issue in the general population
From 2006, we developed and tested the eHealth lifestyle coaching program Smarter Pregnancy in a large survey and randomized controlled trials (RCTs), including a general population cohort and a subfertile cohort of couples receiving either in vitro fertilization or intracytoplasmic sperm injection [4,5]
A periconception lifestyle counseling clinic Healthy Pregnancy and a comparable blended care clinic including the combination of face-to-face counseling and the eHealth coaching program Smarter Pregnancy was developed and evaluated [7,8]
Summary
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 BMI≥25 and who are contemplating pregnancy or are already pregnant (≤12 weeks) in reducing inadequate lifestyle behaviors and improving early and late pregnancy outcome
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