NCT06067906RecruitingNot Applicable
Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
Centre Hospitalier le Mans2 sites in 1 country60 target enrollmentStarted: November 2, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Centre Hospitalier le Mans
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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