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

August 27, 2024 updated by: Centre Hospitalier le Mans

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Mans, France, 72000
        • Recruiting
        • Centre Hospitalier du Mans
        • Contact:
        • Principal Investigator:
          • Françoise LIPPI
        • Sub-Investigator:
          • Coralie BARDOU
        • Sub-Investigator:
          • Jérôme VIGREUX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia
Time Frame: 1 year after care
Efficiency is evaluated by weight measurement
1 year after care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier le Mans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

November 2, 2028

Study Completion (Estimated)

November 2, 2028

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHM-2022/S08/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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