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The PEPP Trial: A Postpartum Bundle Intervention to Improve Cardiometabolic Health in Women After a First Pregnancy Affected by Preeclampsia - a Multi-centre Randomised Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if a postpartum bundle intervention can improve cardiometabolic health and lifestyle-related factors in women who have had preeclampsia during their first pregnancy. The main questions it aims to answer are: * Does the 9-month intervention reduce systolic and diastolic blood pressure? * Does the intervention promote postpartum weight loss? * Does the intervention affect weight and blood pressure depending on early pregnancy BMI? Researchers will compare the bundle intervention to standard care to see if the intervention improves cardiometabolic health and lifestyle outcomes. All participants will attend clinical visits for outcome assessments. Participants in the intervention group will: * Receive online targeted screening and group meetings with study personnel * Use the trial-specific PEPP app to access self-monitoring tools for blood pressure and weight, lifestyle modification, and health education * Follow the intervention in two phases: starting after inclusion (≈8 weeks postpartum) with a Light phase (baseline-3 months) and progressing to an Intensive phase (3-9 months)

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• First-time mothers postpartum

• Preeclampsia during first pregnancy

• Age ≥ 18 years

• Singleton live birth (infant still alive)

• Ability to understand and speak Swedish, English

• Having a smartphone (Android or iOS)

• Ability to provide informed consent

Locations
Other Locations
Sweden
Karolinska Institutet
RECRUITING
Stockholm
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Kari Johansson, PhD
kari.johansson@ki.se
+46851776278
Backup
Anna Sandström, PhD, MD
anna.sandstrom@ki.se
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2028-04
Participants
Target number of participants: 356
Treatments
No_intervention: Standard Care
Standard care
Experimental: Bundle Intervention
Bundle Intervention
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov