Digital support for pregnant women with a BMI of 25 or higher
Official title: Effectiveness of a Digital Support Intervention (HealthyPregnancy) for Pregnant Women with a BMI At 25 or Above (BMI≥25) in Addition to Standard Care: a Stepped-wedge Cluster Randomized Controlled Trial
Run by Center for Clinical Research and Prevention · NCT06734910 · Data updated 2026-11-12
This study is testing a digital care guide to see if it can help pregnant women with a higher BMI manage their weight and improve their mental health during pregnancy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 450 (estimated) |
| Sponsor | Center for Clinical Research and Prevention Research network |
| Locations | 2 sites (Hillerød and 1 other locations) |
| Status | Recruiting |
| Started | September 9, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2027 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06734910 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 18 and older with a BMI of 25 or above at their first prenatal visit.
✕Probably not a fit
Patients who are under 18 years old, have multiple pregnancies, or have conditions contraindicating physical activity during pregnancy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines the effectiveness of a digital care guide designed to support pregnant women with a BMI of 25 or above by providing information on diet, physical exercise, and mental well-being. It employs a stepped-wedge cluster randomized design to assess whether access to this digital intervention can reduce excessive weight gain during pregnancy and improve mental health outcomes. The study addresses the high prevalence of overweight among pregnant women and the associated risks of complications for both mothers and their children. By utilizing digital technology, the study aims to offer a cost-effective alternative to traditional lifestyle interventions.
Why it matters
Potential benefit: If successful, this intervention could help reduce excessive weight gain during pregnancy and improve the mental well-being of participants.
How similar studies have gone: Previous studies have shown that interventions focusing on physical activity and nutritional counseling can effectively reduce excessive weight gain in pregnant women, indicating potential success for this digital approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Nordsjaellands Hospital
Hillerød, Denmark Recruiting -
Slagelse Hospital
Slagelse, Denmark Recruiting
Study contacts
- Study coordinator: Lotte Broberg, Ph.d.
- Email: lotte.broberg.01@regionh.dk
- Phone: +45 38163097
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.