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

Recruiting now · Not applicable

Conditions studied: Pregnancy Related, Weight Gain

In brief

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.

Key facts

Study ID

NCT06734910

Run by

Center for Clinical Research and Prevention

People needed

450

Starts

2024-09-09

Expected to finish

2027-06-01

Last updated by the study team

2024-12-16

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• BMI 25 or above at first prenatal visit
• Age 18 years or older
• Singleton pregnancy
• Appropriate Danish or English language skills
• Written informed consent

You may not qualify if…

• 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.

Where it is running

• Nordsjaellands Hospital — Hillerød, Denmark (enrolling)
• Slagelse Hospital — Slagelse, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.