Comparison of Day Hospitalization Versus Full-Time Hospitalization in the Treatment of Severe Adolescent Obesity (MAROSA)

June 11, 2026 updated by: Fondation Santé des Étudiants de France

Comparison of Day Hospitalization and Full-Time Hospitalization in the Treatment of Severe Adolescent Obesity (MAROSA)

This multicenter prospective quasi-experimental study aims to compare the effectiveness of day hospitalization versus full-time hospitalization for adolescents with severe obesity. The primary outcome is the change in BMI z-score measured six months after the end of treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study evaluates two healthcare delivery models for adolescents with severe obesity: day hospitalization and full-time hospitalization. It examines clinical, biological, psychological, and social outcomes, as well as patient satisfaction and predictors of response. The objective is to identify patient profiles that benefit most from each treatment modality to optimize care pathways

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adolescents aged 12-20 years
  • Severe obesity (IOTF > 30)
  • Admitted to participating centers
  • Covered by health insurance
  • Signed informed consent (participant or legal guardian)

Exclusion Criteria:

  • Acute psychiatric disorder requiring hospitalization
  • Secondary obesity due to endocrine disorders
  • Age < 12 or > 20 years
  • Inability to provide consent Emergency situation Refusal to participate

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Day Hospitalization (DH)
Multidisciplinary day hospital program for adolescents with severe obesity, including medical follow-up, nutritional counseling, physical activity, and psychological support, provided during daytime without overnight stay.
Other: Day Hospital Multidisciplinary Care
Adolescents with severe obesity involved in a day hospital program following standard multidisciplinary care will receive treatment as usual, including medical monitoring, nutritional counseling, physical activity, and psychological support provided during daytime sessions without overnight stay.
Other: Full-Time Hospitalization (FTH)
Multidisciplinary full-time hospitalization program for adolescents with severe obesity, including medical follow-up, nutritional counseling, physical activity, and psychological support, provided with continuous inpatient care.
Other: Full-Time Inpatient Multidisciplinary Care
subjects with Anorexia Nervosa (AN) involved in a day hospital or an inpatient program following HAS guidelines for anorexia nervosa treatment (treatment as usual) who will receive in addition an adapted physical activity program (one lesson per week, during 8 weeks) Adapted Physical Activity program, including psychoeducation on both problematic physical activity and consequences in terms of physical activity good practice leads to a better outcome among persons suffering from anorexia nervosa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hange in BMI z-score
Time Frame: From date of admission (baseline, T0) until the first occurrence of [event of interest], assessed up to 9 months after inclusion.
BMI z-score calculated based on weight, height, sex, and age
From date of admission (baseline, T0) until the first occurrence of [event of interest], assessed up to 9 months after inclusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity assessed using Visual Analog Scale (VAS)
Time Frame: Baseline and end of treatment (3 months)
Pain intensity will be measured using a 0-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
Baseline and end of treatment (3 months)
Quality of life assessed using the SF-36 questionnaire
Time Frame: Baseline and end of treatment (3 months)
Quality of life will be assessed using the Short Form-36 (SF-36), which includes 8 domains. Scores range from 0 to 100, with higher scores indicating better quality of life.
Baseline and end of treatment (3 months)
Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline and end of treatment (3 months)
The HADS questionnaire consists of 14 items, with two subscales (anxiety and depression), each ranging from 0 to 21. Higher scores indicate greater symptom severity.
Baseline and end of treatment (3 months)
Fatigue assessed using the Fatigue Severity Scale (FSS)
Time Frame: Baseline and end of treatment (3 months)
Fatigue will be measured using the Fatigue Severity Scale, consisting of 9 items rated on a 1 to 7 scale. Higher scores indicate greater fatigue severity.
Baseline and end of treatment (3 months)

Collaborators and Investigators

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

Sponsor

Fondation Santé des Étudiants de France

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 (Estimated)

October 5, 2026

Primary Completion (Estimated)

October 10, 2027

Study Completion (Estimated)

November 10, 2027

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A00705-44

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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