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

NCT ID: NCT06067906

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2028-11-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pre-Eclampsia Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

Group Type PLACEBO_COMPARATOR

Hypocaloric diet

Intervention Type OTHER

Hypocaloric diet

innovative group

Group Type EXPERIMENTAL

Dissociated diet

Intervention Type OTHER

Dissociated diet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hypocaloric diet

Hypocaloric diet

Intervention Type OTHER

Dissociated diet

Dissociated diet

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier le Mans

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Du Mans

Le Mans, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christelle JADEAU

Role: primary

+33244710781

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHM-2022/S08/12

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Newborns of Obese Mothers
NCT02681588 COMPLETED NA
The PreEclampsia Postpartum Prevention Trial
NCT07199283 NOT_YET_RECRUITING NA