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

Primary Purpose

Pre-Eclampsia, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypocaloric diet
Dissociated diet
Sponsored by
Centre Hospitalier le Mans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pre-Eclampsia focused on measuring pre-eclampsia, obesity, dissociated diet

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre Hospitalier Du MansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

innovative group

Arm Description

Outcomes

Primary Outcome Measures

Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia
Efficiency is evaluated by weight measurement

Secondary Outcome Measures

Full Information

First Posted
September 28, 2023
Last Updated
September 28, 2023
Sponsor
Centre Hospitalier le Mans
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1. Study Identification

Unique Protocol Identification Number
NCT06067906
Brief Title
Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
Acronym
POPADIPE
Official Title
Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
September 14, 2028 (Anticipated)
Study Completion Date
September 14, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Obesity
Keywords
pre-eclampsia, obesity, dissociated diet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Title
innovative group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Hypocaloric diet
Intervention Description
Hypocaloric diet
Intervention Type
Other
Intervention Name(s)
Dissociated diet
Intervention Description
Dissociated diet
Primary Outcome Measure Information:
Title
Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia
Description
Efficiency is evaluated by weight measurement
Time Frame
1 year after care

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle JADEAU
Phone
+33244710781
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Françoise LIPPI
First Name & Middle Initial & Last Name & Degree
Coralie BARDOU
First Name & Middle Initial & Last Name & Degree
Jérôme VIGREUX

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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