NCT06239662

Therapeutic Education Groups for Childhood Obesity

Therapeutic Education Groups for Childhood Obesity: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Childhood Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Therapeutic 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.
BEHAVIORAL	Usual care	The dietician will meet individually each child together with parents. Dietician will provide nutritional advices.

Timeline

• Start date: 2016-09-22
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2024-02-02
• Last updated: 2024-04-01