Childhood Obesity
Conditions
Keywords
Childhood obesity, Group Intervention, Psychological Aspects
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.
Interventions
BEHAVIORALTherapeutic Group
The first part of each meeting, lasting 45 minutes, will be held only with children and young people, while parents will wait in the waiting room. At the end of the first part, for each meeting, the children will be asked to make a commitment relating to the topics covered, which will be verified in the following meeting. Once the part with the patients has concluded, they will be accompanied to an adjacent environment where a pediatrician volunteer will be waiting for them and will offer fun and socialization activities. In the meantime, the parents will be seated and will address, together with the team staff, the same issues discussed with their children, again for a duration of approximately 45 minutes. Parents will also be invited to make a commitment similar to that required of children.
BEHAVIORALUsual care
The dietician will meet individually each child together with parents. Dietician will provide nutritional advices.
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI z-score | measurement at end of treatment i.e approximately 24 months after baseline measurements | BMI z-score variation from baseline to end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| unhealthy dietary habits | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the weekly consumption (in frequency) of packed and high-calorie food measurment at end of treatment i.e approximately 24 months after baseline measurements |
| Biohumoral exams from blood sample: Uric acid | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the value measurements (differences expressed in mg/dL) at end of treatment i.e approximately 24 months after baseline measurements |
| Biohumoral exams from blood sample: Transaminases | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the value measurements (differences expressed in U/l) at end of treatment i.e approximately 24 months after baseline measurements |
| Biohumoral exams from blood sample: Glycemia | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the value measurements (differences expressed in mg/dL) at end of treatment i.e approximately 24 months after baseline measurements |
| Biohumoral exams from blood sample: Insulin | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the value measurements (differences expressed in µU/mL) at end of treatment i.e approximately 24 months after baseline measurements |
| Biohumoral exams from blood sample: Glycated hemoglobin | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the value measurements (differences expressed mmol/moli) at end of treatment i.e approximately 24 months after baseline measurements |
| healthy dietary habits | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the daily consumption (in frequency) of fruits and vegetables measurement at end of treatment i.e approximately 24 months after baseline measurements |
| Biohumoral exams from blood sample: Triglycerides | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the value measurements (differences expressed mg/dL) at end of treatment i.e approximately 24 months after baseline measurements |
| Biohumoral exams from blood sample: Thyroid-stimulating hormone | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the value measurements (differences expressed μIU/ml) at end of treatment i.e approximately 24 months after baseline measurements |
| Psychological questionnaire TAS-20 (Toronto Alexithymia Scale) | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in TAS-20 overall and sub-scale scores (differences) from baseline to the end of treatment i.e approximately 24 months after baseline measurements.Scoring range: 20-100; cutoff 60 (higher scores indicate greater impairment/challenges). |
| Psychological questionnaire PEDSQL (Pediatric Quality of life) | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in PEDSQL overall and sub-scale scores (differences) from baseline to the end of treatment i.e approximately 24 months after baseline measurements. Scores are linearly transformed to a 0-100 scale in which high score means better condition. |
| Psychological questionnaire CBCL (Child Behaviour Checklist) | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in CBCL overall and sub-scale scores (differences) from baseline to the end of treatment i.e approximately 24 months after baseline measurements. Scores below the 93rd percentile is considered normal, scores between the 93-97th percentile are borderline clinical, and scores above the 97th percentile are in the clinical range. |
| Drop-out | measurement at end of treatment i.e approximately 24 months after baseline measurements | qualitative differences between experimental and control group in drop-out per cent |
| Biohumoral exams from blood sample: Cholesterol | measurement at end of treatment i.e approximately 24 months after baseline measurements | variation in the value measurements (differences expressed mg/dL) at end of treatment i.e approximately 24 months after baseline measurements |
Outcome results
None listed