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

Obesity Clinical Trial

— POPADIPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067906
• Other study ID #: CHM-2022/S08/12
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: September 14, 2028

Study information

• Verified date: September 2023
• Source: Centre Hospitalier le Mans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 14, 2028
• Est. primary completion date: September 14, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Obesity
• Overweight
• Pre-Eclampsia
• Weight Loss

Intervention

Other:
• Hypocaloric diet
Hypocaloric diet
• Dissociated diet
Dissociated diet

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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