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Completed

NCT Number: NCT06239662

Therapeutic Education Groups for Childhood Obesity

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.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic Group

Behavioral

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.

Usual Care

Behavioral

The dietician will meet individually each child together with parents. Dietician will provide nutritional advices.

Primary outcomes

  1. BMI z-score

    Time frame: measurement at end of treatment i.e approximately 24 months after baseline measurements

    BMI z-score variation from baseline to end of treatment

  2. 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

  1. healthy dietary habits

    Time frame: 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

  2. healthy dietary habits

    Time frame: 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

  3. unhealthy dietary habits

    Time frame: 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

  4. unhealthy dietary habits

    Time frame: 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

  5. Biohumoral exams from blood sample: Uric acid

    Time frame: 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

  6. Biohumoral exams from blood sample: Transaminases

    Time frame: 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

  7. Biohumoral exams from blood sample: Glycemia

    Time frame: 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

  8. Biohumoral exams from blood sample: Insulin

    Time frame: 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

  9. Biohumoral exams from blood sample: Glycated hemoglobin

    Time frame: 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

  10. Biohumoral exams from blood sample: Cholesterol

    Time frame: 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

  11. Biohumoral exams from blood sample: Triglycerides

    Time frame: 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

  12. Biohumoral exams from blood sample: Thyroid-stimulating hormone

    Time frame: 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

  13. Biohumoral exams from blood sample: Uric acid

    Time frame: 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

  14. Biohumoral exams from blood sample: Transaminases

    Time frame: 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

  15. Biohumoral exams from blood sample: Glycemia

    Time frame: 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

  16. Biohumoral exams from blood sample: Insulin

    Time frame: 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

  17. Biohumoral exams from blood sample: Glycated hemoglobin

    Time frame: 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

  18. Biohumoral exams from blood sample: Cholesterol

    Time frame: 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

  19. Biohumoral exams from blood sample: Triglycerides

    Time frame: 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

  20. Biohumoral exams from blood sample: Thyroid-stimulating hormone

    Time frame: 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

  21. Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)

    Time frame: 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).

  22. Psychological questionnaire TAS-20 (Toronto Alexithymia Scale)

    Time frame: 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).

  23. Psychological questionnaire PEDSQL (Pediatric Quality of life)

    Time frame: 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.

  24. Psychological questionnaire PEDSQL (Pediatric Quality of life)

    Time frame: 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.

  25. Psychological questionnaire CBCL (Child Behaviour Checklist)

    Time frame: 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.

  26. Psychological questionnaire CBCL (Child Behaviour Checklist)

    Time frame: 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

  27. Drop-out

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

Therapeutic Education Groups for Childhood Obesity: a Randomized Controlled Trial

Acronym: GET-Obesity

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2024
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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