Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
NCT06734910

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

Led by Center for Clinical Research and Prevention · Updated on 2024-12-16

450

Participants Needed

2

Research Sites

142 weeks

Total Duration

On this page

Sponsors

C

Center for Clinical Research and Prevention

Lead Sponsor

N

Nordsjaellands Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI 25 or above at first prenatal visit
  • Age 18 years or older
  • Singleton pregnancy
  • Appropriate Danish or English language skills
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Multiple pregnancy
  • Gestational age above 16+0 at inclusion
  • Alcohol or drug abuse
  • Diagnosis of eating disorder, schizophrenia, psychosis, or similar
  • Diagnosis of malformations or chromosomal disorder in the fetus
  • Conditions recommending against physical activity during pregnancy (e.g., cerclage)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Nordsjaellands Hospital

Hillerød, Denmark

Actively Recruiting

2

Slagelse Hospital

Slagelse, Denmark

Actively Recruiting

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Research Team

L

Lotte Broberg, Ph.d.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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