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Not yet recruiting NCT07652190

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

No phase Interventional Severe Adolescent Obesity Adolescent Obesity Pediatric Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Day Hospital Multidisciplinary Care, Full-Time Inpatient Multidisciplinary Care.
Who it may be relevant to
Registry conditions: Severe Adolescent Obesity, Adolescent Obesity, Pediatric Obesity. Basic parameters: 12 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Interventions

  • 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 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.

Primary outcome measures

  • 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.]
Secondary outcome measures (4)
  • Pain intensity assessed using Visual Analog Scale (VAS) [Time frame: 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)]
  • Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline and end of treatment (3 months)]
  • Fatigue assessed using the Fatigue Severity Scale (FSS) [Time frame: Baseline and end of treatment (3 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07652190 · 2025-A00705-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗