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New treatment option for Pregnancy Related
Official title HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)
ClinicalTrials.gov ID: NCT06734910
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hillerød, Denmark
- Slagelse, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hillerød, Denmark; Slagelse, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.