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Recruiting NCT06734910

HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)

Trial Parameters

Condition Pregnancy Related
Sponsor Center for Clinical Research and Prevention
Study Type INTERVENTIONAL
Phase N/A
Enrollment 450
Sex FEMALE
Min Age 18 Years
Max Age 60 Years
Start Date 2024-09-09
Completion 2026-06
Interventions
HealthyPregnancy

Brief Summary

The study aims to examine the effectiveness of a digital care guide offering support and information on diet, physical exercise and mental well-being on pregnancy weight gain among pregnant women with a BMI at 25 or above in a stepped-wedge cluster randomised study. The investigators hypothesise that access to a digital care guide focusing on diet, exercise and mental support, will support a reduced weight gain in pregnancy and improve the mental wellbeing of the participants.

Eligibility Criteria

Inclusion Criteria: * BMI 25 or above at first prenatal visit * Age 18 years or older * Singleton pregnancy * Appropriate Danish or English language skills * Written informed consent Exclusion Criteria: * Age under 18 years * Multiple pregnancy * Gestational age above 16+0 at inclusion * Alcohol or drug abuse * Being diagnosed with eating disorder, schizophrenia, psychosis, or similar * Diagnosis of malformations or chromosomal disorder in the fetus * Conditions that lead to recommendations against physical activity during pregnancy e.g., cerclage.

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