跳至主要内容
临床试验/NCT06067906
NCT06067906招募中不适用

Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients

Centre Hospitalier le Mans1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia

研究概览

简要总结

In view of the known link between pre-eclampsia, overweight/obesity and chronic kidney disease, the aim is to offer for obese and overweight patients to reduce their BMI without reducing lean body mass.

The POPADIPE project will make it possible to limit overweight or obesity by means of nutritional management chosen by the patient (hypocaloric or a dissociated diet). The latter has been the subject of little scientific investigation, particularly in relation to the management of post-pre-eclampsia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Person affiliated to social security
  • •Free, informed and written consent signed by the participant and the investigator (no later than the day of day of inclusion and before any examination required by the research)
  • •Patient over 18 years of age at the time of inclusion and < 45 years of age
  • •Having had an pre-eclampsia in the last 5 years according to the definitions of the ISSHP 2018
  • •Patient with a BMI between 25 kg/m² and 40 kg/m² who accepts dietetic follow up
  • •Patient with a medical prescription for dietetic follow-up aimed at losing weight loss
  • •Patient with a balanced diet

排除标准

  • •Patients with a mental disability or language barrier that prevents them from understanding or consenting to the study
  • •Patients deprived of their liberty by judicial or administrative decision
  • •Patients under psychiatric care
  • •Patients subject to a legal protection measure
  • •Patients with cognitive disorders or defined eating disorders
  • •Patients who are pregnant or breast-feeding
  • •Patients undergoing steroid treatment and/or immunosuppression
  • •Have been on a low-calorie or dissociated diet for at least 6 months
  • •Patients with CKD stage ≥ 3A

研究组 & 干预措施

control group

Placebo Comparator

干预措施: Hypocaloric diet (Other)

innovative group

Experimental

干预措施: Dissociated diet (Other)

结局指标

主要结局

Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia

时间窗: 1 year after care

Efficiency is evaluated by weight measurement

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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