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

NCT07652190 | Not Yet Recruiting

• 1 other identifier: 2025-A00705-44
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Severe Adolescent Obesity; Adolescent Obesity; Pediatric Obesity

Outcome Measures

Primary Outcomes (1)

• hange in BMI z-score

  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 Outcomes (4)

• Pain intensity assessed using Visual Analog Scale (VAS)

  Baseline and end of treatment (3 months)

• Quality of life assessed using the SF-36 questionnaire

  Baseline and end of treatment (3 months)

• Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS)

  Baseline and end of treatment (3 months)

• Fatigue assessed using the Fatigue Severity Scale (FSS)

  Baseline and end of treatment (3 months)

Study Arms (2)

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.

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.

Other: Full-Time Inpatient Multidisciplinary Care

Interventions

Day Hospital Multidisciplinary Care OTHER

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.

Day Hospitalization (DH)

Full-Time Inpatient Multidisciplinary Care OTHER

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.

Full-Time Hospitalization (FTH)

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Santé des Étudiants de France: lead

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06