Adolescent Obesity, Pediatric Obesity, Severe Adolescent Obesity
Conditions
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.
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
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.
Sponsors
Fondation Santé des Étudiants de France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hange in BMI z-score | From date of admission (baseline, T0) until the first occurrence of [event of interest], assessed up to 9 months after inclusion. | BMI z-score calculated based on weight, height, sex, and age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity assessed using Visual Analog Scale (VAS) | Baseline and end of treatment (3 months) | Pain intensity will be measured using a 0-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates worst imaginable pain. |
| Quality of life assessed using the SF-36 questionnaire | Baseline and end of treatment (3 months) | 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. |
| Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS) | Baseline and end of treatment (3 months) | 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. |
| Fatigue assessed using the Fatigue Severity Scale (FSS) | Baseline and end of treatment (3 months) | 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. |
Outcome results
None listed