Therapeutic Education Groups for Childhood Obesity: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Childhood Obesity
- Sponsor
- Azienda Unità Sanitaria Locale Reggio Emilia
- Enrollment
- 318
- Primary Endpoint
- BMI z-score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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;
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
BMI z-score
Time Frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
BMI z-score variation from baseline to 18 months after the and of treatment
Secondary Outcomes
- Biohumoral exams from blood sample: Thyroid-stimulating hormone(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- healthy dietary habits(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- unhealthy dietary habits(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Cholesterol(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Psychological questionnaire CBCL (Child Behaviour Checklist)(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Drop-out(measurement at end of treatment i.e approximately 24 months after baseline measurements)
- Biohumoral exams from blood sample: Uric acid(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Transaminases(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Glycemia(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Insulin(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Glycated hemoglobin(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Biohumoral exams from blood sample: Triglycerides(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)
- Psychological questionnaire PEDSQL (Pediatric Quality of life)(measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements)