Therapeutic Education Groups for Childhood Obesity

Not Applicable

Completed

• Conditions: Childhood Obesity
• Interventions: Behavioral: Usual care; Behavioral: Therapeutic Group

• Registration Number: NCT06239662
• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

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.

Study Timeline

• Study Start: 2016-09-22
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-10
• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	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.
Therapeutic group intervention	Therapeutic Group	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.

Primary Outcome Measures

Name	Time	Method
BMI z-score	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 Outcome Measures

Name	Time	Method
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	variation in the value measurements (differences expressed in μIU/ml) from baseline to 18 months after the and of treatment
healthy dietary habits	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	variation in the daily consumption (in frequency) of fruits and vegetables measurement from baseline to 18 months after the and of treatment
unhealthy dietary habits	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	variation in the weekly consumption (in frequency) of packed and high-calorie food measurment from baseline to 18 months after the and of treatment
Biohumoral exams from blood sample: Cholesterol	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Psychological questionnaire CBCL (Child Behaviour Checklist)	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	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
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: Uric acid	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Biohumoral exams from blood sample: Transaminases	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	variation in the value measurements (differences expressed in U/l) from baseline to 18 months after the and of treatment
Biohumoral exams from blood sample: Glycemia	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Biohumoral exams from blood sample: Insulin	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	variation in the value measurements (differences expressed in µU/mL) from baseline to 18 months after the and of treatment
Biohumoral exams from blood sample: Glycated hemoglobin	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	variation in the value measurements (differences expressed in mmol/moli) from baseline to 18 months after the and of treatment
Biohumoral exams from blood sample: Triglycerides	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	variation in the value measurements (differences expressed in mg/dL) from baseline to 18 months after the and of treatment
Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	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).
Psychological questionnaire PEDSQL (Pediatric Quality of life)	measurement at 18 months after the end of treatment i.e approximately 42 months after baseline measurements	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.