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

N/ANot Yet RecruitingNCT07652190

Fondation Santé des Étudiants de France126 enrolled

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Severe Adolescent Obesity Adolescent Obesity Pediatric Obesity

Interventions

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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)

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)

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)

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)

Data from ClinicalTrials.gov

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