NCT Number: NCT07652190
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.
Trial opening soon.
Get Notified12 year–20 year
All sexes
Interventional
Not applicable
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Fondation Santé des Étudiants de France
Other
Comparison of Day Hospitalization and Full-Time Hospitalization in the Treatment of Severe Adolescent Obesity (MAROSA)
Acronym: MAROSA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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