An interventional study of Therapeutic Group and Usual care in Childhood Obesity, sponsored by Azienda USL Reggio Emilia - IRCCS. Completed. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Azienda USL Reggio Emilia - IRCCS · Not applicable, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 318 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 92 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Patients will be called in groups every 3 months for a total of 10 meetings. At each meeting they will be weighed and measured. Each meeting will focus on a topic of nutritional/lifestyle interest and will see the co-presence of the figures of the dietician and the psychologist, in order to allow an emotional declination for all the participants.
Behavioral: Therapeutic Group
Patients will be called individually every 3 months for a total of 10 meetings. At each meeting they will be weighed and measured. Each meeting will focus on a topic of nutritional/lifestyle interest. The meetings will be conducted by a dietician.
Behavioral: Usual care
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.
The dietician will meet individually each child together with parents. Dietician will provide nutritional advices.
BMI z-score
BMI z-score variation from baseline to end of treatment
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
BMI z-score
BMI z-score variation from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
healthy dietary habits
variation in the daily consumption (in frequency) of fruits and vegetables measurement at end of treatment i.e approximately 24 months after baseline measurements
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
healthy dietary habits
variation in the daily consumption (in frequency) of fruits and vegetables measurement from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
unhealthy dietary habits
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
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
unhealthy dietary habits
variation in the weekly consumption (in frequency) of packed and high-calorie food measurment from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Uric acid
variation in the value measurements (differences expressed in mg/dL) at end of treatment i.e approximately 24 months after baseline measurements
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Transaminases
variation in the value measurements (differences expressed in U/l) at end of treatment i.e approximately 24 months after baseline measurements
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Glycemia
variation in the value measurements (differences expressed in mg/dL) at end of treatment i.e approximately 24 months after baseline measurements
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Insulin
variation in the value measurements (differences expressed in µU/mL) at end of treatment i.e approximately 24 months after baseline measurements
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Glycated hemoglobin
variation in the value measurements (differences expressed mmol/moli) at end of treatment i.e approximately 24 months after baseline measurements
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Cholesterol
variation in the value measurements (differences expressed mg/dL) at end of treatment i.e approximately 24 months after baseline measurements
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Triglycerides
variation in the value measurements (differences expressed mg/dL) at end of treatment i.e approximately 24 months after baseline measurements
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Thyroid-stimulating hormone
variation in the value measurements (differences expressed μIU/ml) at end of treatment i.e approximately 24 months after baseline measurements
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Biohumoral exams from blood sample: Uric acid
variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Transaminases
variation in the value measurements (differences expressed in U/l) from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Glycemia
variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Insulin
variation in the value measurements (differences expressed in µU/mL) from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Glycated hemoglobin
variation in the value measurements (differences expressed in mmol/moli) from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Cholesterol
variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Triglycerides
variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Biohumoral exams from blood sample: Thyroid-stimulating hormone
variation in the value measurements (differences expressed in μIU/ml) from baseline to 18 months after the and of treatment
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)
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).
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)
variation in TAS-20 overall and sub-scale scores (differences) from baseline to approximately 18 months after the end of treatment. Scoring range: 20-100; cutoff 60 (higher scores indicate greater impairment/challenges).
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Psychological questionnaire PEDSQL (Pediatric Quality of life)
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.
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Psychological questionnaire PEDSQL (Pediatric Quality of life)
variation in PEDSQL overall and sub-scale scores (differences) from baseline to approximately 18 months after the end of treatment. Scores are linearly transformed to a 0-100 scale in which high score means better condition.
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Psychological questionnaire CBCL (Child Behaviour Checklist)
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.
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
Psychological questionnaire CBCL (Child Behaviour Checklist)
variation in CBCL overall and sub-scale scores (differences) from baseline to approximately 18 months after the end of treatment. 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
Time frame: measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements
Drop-out
qualitative differences between experimental and control group in drop-out per cent
Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements
No study locations are listed for this record.
Plan to share: Undecided — We do not have the authorization to share IPD. We are in the process to agree with the Ethic Committee how the share data.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Azienda USL Reggio Emilia - IRCCS