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

NCT06067906 | Recruiting

• 1 other identifier: CHM-2022/S08/12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia; Obesity

Keywords

pre-eclampsia; obesity; dissociated diet

Outcome Measures

Primary Outcomes (1)

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

  Efficiency is evaluated by weight measurement

  1 year after care

Study Arms (2)

control group

PLACEBO COMPARATOR

Other: Hypocaloric diet

innovative group

EXPERIMENTAL

Other: Dissociated diet

Interventions

Hypocaloric diet OTHER

Hypocaloric diet

control group

Dissociated diet OTHER

Dissociated diet

innovative group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Person affiliated to social security
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Obesity

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): November 2, 2028
• Study Completion (Estimated): November 2, 2028
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)