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

ConditionsSevere Adolescent ObesityAdolescent ObesityPediatric Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-20
SponsorFondation Santé des Étudiants de France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adolescents aged 12-20 years

Severe obesity (IOTF > 30)

Admitted to participating centers

Covered by health insurance

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Day Hospital Multidisciplinary Care

    Other intervention

    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 Care

    Other intervention

    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.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Day Hospitalization (DH)Other 1 intervention
Group B: Full-Time Hospitalization (FTH)Other 1 intervention

Trial outcomes

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondation Santé des Étudiants de France

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: