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Not yet recruitingNCT07652190MAROSAUpdated Jun 16, 2026

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

An interventional study of Day Hospital Multidisciplinary Care and Full-Time Inpatient Multidisciplinary Care in Severe Adolescent Obesity, Adolescent Obesity and Pediatric Obesity, sponsored by Fondation Santé des Étudiants de France. Not yet recruiting. Open to participants aged 12 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Fondation Santé des Étudiants de France · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Non-randomized
Ages
12 Years to 20 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Severe Adolescent Obesity
  • Adolescent Obesity
  • Pediatric Obesity

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03

Who can participate

Ages eligible
12 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherDay 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.

  • OtherFull-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.

05

What researchers measure

Primary outcomes

  1. hange in BMI z-score

    BMI z-score calculated based on weight, height, sex, and age

    Time frame: From date of admission (baseline, T0) until the first occurrence of [event of interest], assessed up to 9 months after inclusion.

Secondary outcomes

  1. 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.

    Time frame: Baseline and end of treatment (3 months)

  2. 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.

    Time frame: Baseline and end of treatment (3 months)

  3. 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.

    Time frame: Baseline and end of treatment (3 months)

  4. 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.

    Time frame: Baseline and end of treatment (3 months)

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07652190
Lead sponsor
Fondation Santé des Étudiants de France
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Oct 5, 2026 (estimated)
Primary completion
Oct 10, 2027 (estimated)
Completion
Nov 10, 2027 (estimated)
Last update
Jun 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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