Severe Adolescent ObesityMAROSANCT07652190

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

A study testing Day Hospital Multidisciplinary Care and Full-Time Inpatient Multidisciplinary Care in people with Severe Adolescent Obesity and Adolescent Obesity, run by Fondation Santé des Étudiants de France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 12 to 20 years
Conditions the study is for: Severe Adolescent Obesity, Adolescent Obesity, Pediatric Obesity
What is being tested?: Day Hospital Multidisciplinary Care and Full-Time Inpatient Multidisciplinary Care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: No sites listed yet
Study dates: 5 Oct 2026to 10 Nov 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

About this study

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

Read the 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

Conditions: Severe Adolescent Obesity, Adolescent Obesity, Pediatric Obesity
Being tested: Day Hospital Multidisciplinary Care, Full-Time Inpatient Multidisciplinary Care
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Day Hospital Multidisciplinary CareOther
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.
Full-Time Inpatient Multidisciplinary CareOther
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.

Study groups in NCT07652190
Study group	Role	What they receive
Day Hospitalization (DH)	Other	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. Receives: Other: Day Hospital Multidisciplinary Care
Full-Time Hospitalization (FTH)	Other	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. Receives: Other: Full-Time Inpatient Multidisciplinary Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Pain intensity assessed using Visual Analog Scale (VAS)
Pain intensity will be measured using a 0-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: Baseline and end of treatment (3 months)
Quality of life assessed using the SF-36 questionnaire
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.
Measured: Baseline and end of treatment (3 months)
Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Baseline and end of treatment (3 months)
Fatigue assessed using the Fatigue Severity Scale (FSS)
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.
Measured: Baseline and end of treatment (3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202610 Nov 2027

First posted16 Jun 2026
Study start5 Oct 2026 (estimated)
Primary completion10 Oct 2027 (estimated)
Study completion10 Nov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Severe Adolescent ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Participants are assigned to one of two parallel groups based on the type of care provided at each participating center: day hospitalization or full-time hospitalization. This is a non-randomized, quasi-experimental multicenter study in which allocation depends on the standard care model available at each site. Outcomes are compared between groups at baseline, end of treatment, and 6 months after completion of care.
Masking: None (open label)
Enrolment: 126 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07652190
Sponsor's protocol ID: 2025-A00705-44
Acronym: MAROSA
Status last verified: Jun 2026
First submitted: 12 May 2026
Last updated: 16 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No