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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 356
- 试验地点
- 2
- 主要终点
- Change in diastolic blood pressure (mmHg)
研究概览
简要总结
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)
详细描述
PURPOSE AND AIMS:
The overall aim of this 9-month multicentre, two-arm, single-blind, parallel-group RCT starting 6-11 weeks postpartum across several regions in Sweden is to improve cardiometabolic health in women after a first pregnancy complicated by preeclampsia, through a bundle intervention of combined evidence-based components delivered primarily via a trial-specific mobile health (mHealth) app.
The primary aim of the 9-months PEPP (PreEclampsia Postpartum Prevention) randomized controlled trial (RCT) is to evaluate if a bundle intervention is more effective than standard postpartum care in reducing systolic and diastolic blood pressure levels among first-time mothers with a recent diagnosis of preeclampsia.
Secondary aims are to evaluate whether the bundle intervention, compared to standard care, leads to greater postpartum weight loss (i.e. reduction of pregnancy-related weight gain).
Exploratory aims are to evaluate if the intervention improves the identification of additional CVD risk factors, enhances patient CVD awareness, increases physical activity, promotes a healthier diet, and improves wellbeing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pre-pregnancy hypertension
- •Diabetes mellitus type I or II
- •Cardiovascular disease
- •Kidney disease
- •Systemic lupus erythematosus
- •Antiphospholipid syndrome
- •Previous or current eating disorders
- •Ongoing new pregnancy
研究组 & 干预措施
Standard Care
Standard care
Bundle Intervention
Bundle Intervention
干预措施: Bundle Intervention (Other)
结局指标
主要结局
Change in diastolic blood pressure (mmHg)
时间窗: From baseline to end of study at 9 months follow-up
Change in diastolic blood pressure (mmHg), recorded in single digits using a validated automatic blood pressure monitor.
Change in systolic (sBP) blood pressure (mmHg)
时间窗: From baseline to end of study at 9 months follow-up
Change in systolic blood pressure (mmHg), recorded in single digits using a validated automatic blood pressure monitor.
次要结局
- Change in postpartum weight (kilograms, kg)(From baseline to end of study at 9 months follow-up)
研究者
Kari Johansson
Associate Professor
Karolinska Institutet