Clinical trial NCT06239662: Therapeutic Education Groups for Childhood Obesity
Official title: Therapeutic Education Groups for Childhood Obesity: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood obesity
Group Intervention
Psychological Aspects
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2024-02-02
Enrollment: 318
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the efficacy of an educational therapeutic intervention in treating obesity in a pediatric population.

It aims to verify the differences between the experimental group (group-based program) and the control group (individual program) in respect to the BMI z-score values between baseline measurement (beginning of treatment), final measurement (end of treatment) and 18 months follow-up.

Detailed description: One of the aim of this clinical trial is to verify that the direct management of the emotional and relational aspects of patients and family plays an important role in maintaining the weight changes achieved in the long term.

The potential added value of the present study concerns the better understanding of the role of psychological and emotional aspects in the treatment of childhood obesity and in maintaining results in the long term.

The clinical trial aims to recruit 300 obese children randomized in two groups: experimental group and control group.

Eligibility criteria: Inclusion Criteria:

* Obesity (\>= 95th percentile);
* No organic causes of obesity;
* Sufficient understanding and production of Italian language;
* Age between 7 and 17 years old;
* Absence of neuropsychiatric diagnosis;
* Subscription of the Informed Consent from both parents (or legal guardian).

Exclusion Criteria

* Degree of obesity\< 95th percentile;
* Organic causes of obesity;
* Insufficient understanding and production of Italian language;
* Age \<7 or \>17;
* Presence of neuropsychiatric diagnosis;
* One parent (or legal guardian) refuses to subscribe the Informed Consent.

Primary outcomes:
measure: BMI z-score
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: BMI z-score
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Secondary outcomes:
measure: healthy dietary habits
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: healthy dietary habits
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: unhealthy dietary habits
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: unhealthy dietary habits
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Biohumoral exams from blood sample: Uric acid
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Biohumoral exams from blood sample: Transaminases
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Biohumoral exams from blood sample: Glycemia
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Biohumoral exams from blood sample: Insulin
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Biohumoral exams from blood sample: Glycated hemoglobin
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Biohumoral exams from blood sample: Cholesterol
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Biohumoral exams from blood sample: Triglycerides
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Biohumoral exams from blood sample: Thyroid-stimulating hormone
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Biohumoral exams from blood sample: Uric acid
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Biohumoral exams from blood sample: Transaminases
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Biohumoral exams from blood sample: Glycemia
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Biohumoral exams from blood sample: Insulin
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Biohumoral exams from blood sample: Glycated hemoglobin
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Biohumoral exams from blood sample: Cholesterol
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Biohumoral exams from blood sample: Triglycerides
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Biohumoral exams from blood sample: Thyroid-stimulating hormone
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Psychological questionnaire PEDSQL (Pediatric Quality of life)
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Psychological questionnaire PEDSQL (Pediatric Quality of life)
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Psychological questionnaire CBCL (Child Behaviour Checklist)
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
measure: Psychological questionnaire CBCL (Child Behaviour Checklist)
timeFrame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
measure: Drop-out
timeFrame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Other outcomes:
Locations:
Study officials:
affiliation: Azienda USL - IRCCS di Reggio Emilia
name: Marta Fontana, Psycologist
role: PRINCIPAL_INVESTIGATOR
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