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

Sponsor

Centre Hospitalier le Mans (Other)

Overall Status

Recruiting

CT.gov ID

NCT06067906

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-Eclampsia Obesity	Other: Hypocaloric diet Other: Dissociated diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 14, 2023

Anticipated Primary Completion Date :

Sep 14, 2028

Anticipated Study Completion Date :

Sep 14, 2028

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control group	Other: Hypocaloric diet Hypocaloric diet
Experimental: innovative group	Other: Dissociated diet Dissociated diet

Arm

Intervention/Treatment

Placebo Comparator: control group

Other: Hypocaloric diet

Hypocaloric diet

Experimental: innovative group

Other: Dissociated diet

Dissociated diet

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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