Therapeutic Education Groups for Childhood Obesity (GET-Obesity)

Azienda Unità Sanitaria Locale Reggio Emilia

Status: Completed

Conditions: Childhood Obesity

Treatments: Behavioral: Therapeutic Group; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06239662

GET-Obesità N.01-18/02/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 318 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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318 participants in 2 patient groups

Therapeutic group intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Therapeutic Group

Usual care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual care