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Optimizing periconceptional lifestyle of overweight women using a blended personalized care intervention combining eHealth and Face-to-face coUnSEling: The Randomized Controlled eFUSE Trial

eFUSE: Optimizing periconceptional lifestyle of overweight women using a blended personalized care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21869
Enrollment
626
Registered
2021-02-23
Start date
2021-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overweight

Interventions

Blended personalized periconception lifestyle approach, consisting of: 1. A periconception eHealth platform, providing personalized risk assessment and nutrition and lifestyle counselling via the evid

Sponsors

Erasmus MC, University Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient-couples will be screened for eligibility by their treating physician if: - woman is in reproductive age (18-45 year) - they are contemplating pregnancy or are pregnant (=12 weeks gestation) - they visit the outpatient antenatal clinic in this academic care hospital - the woman is overweight (BMI =25)

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - multiple pregnancy - insufficient knowledge of Dutch language - fetal anomalies - inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
Lifestyle Risk Score (between baseline and 24 weeks) between the randomization arms (difference in differences)

Secondary

MeasureTime frame
Measurements defined as most relevant by International Consortium for Health Outcomes Measurement (ICHOM), including behavioral determinants, patient satisfaction, provider feasibility and maternal pregnancy and neonatal complications

Contacts

Public ContactSam Schoenmakers

Erasmus MC

s.schoenmakers@erasmusmc.nl0031107043599

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)