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

Not Applicable

Recruiting

• Conditions: Pre-Eclampsia; Obesity
• Interventions: Other: Dissociated diet; Other: Hypocaloric diet

• Registration Number: NCT06067906
• Lead Sponsor: Centre Hospitalier le Mans

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Study Start: 2023-11-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2028-11-02
• Study Completion: 2028-11-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
innovative group	Dissociated diet	-
control group	Hypocaloric diet	-

Primary Outcome Measures

Name	Time	Method
Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia	1 year after care	Efficiency is evaluated by weight measurement

Trial Locations

Locations (1)

Centre Hospitalier Du Mans; 🇫🇷 Le Mans, France