Menu
Recruiting NCT06067906

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

No phase Interventional Pre-Eclampsia Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypocaloric diet, Dissociated diet.
Who it may be relevant to
Registry conditions: Pre-Eclampsia, Obesity. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Hypocaloric diet
    Hypocaloric diet
  • Other Dissociated diet
    Dissociated diet

Primary outcome measures

  • Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia [Time frame: 1 year after care]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Centre Hospitalier Du Mans — Le Mans

Identifiers

NCT: NCT06067906 · CHM-2022/S08/12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗