Local Proof of Concept of Evira in Abu Dhabi Study

Sheikh Shakhbout Medical City

Status: Completed

Conditions: Childhood Obesity; Treatment Adherence; Adolescent Obesity

Treatments: Device: Digi-physical treatment tool

Study type: Interventional

Funder types: Other

Identifiers

NCT06665893

EviraUAE

Details and patient eligibility

About

Evira is a digital treatment tool developed for treatment of childhood obesity. Through daily weighings at home using a special scale together with a message function in the Evira application, parents and the clinicians can easily follow the child's weight development. The primary aim of this study is to evaluate its efficacy for childhood obesity treatment in Abu Dhabi, with a secondary objective to establish non-inferiority compared to outcomes in a cohort in Stockholm, Sweden.

Full description

Obesity remains a critical global health concern. Traditional treatment often yields limited results, necessitating innovative solutions.

In this study, participants aged 6-15.9 years with obesity at the Sheikh Shakabout Medical City in Abu Dhabi, will be asked for participation. If agreed to participate, they will use a digital treatment tool as a complement to behavioral treatment.The treatment is based on outcome goals set by the treatment staff together with the family. Briefly, the families follow the child's weight outcome via daily weight measurements and the outcome is shown graphically in the mobile application as BMI SDS with the BMI SDS weight goals as background. The staff will provide support to the families via the app. The staff is encouraged to react and contact the families if the weight goals are not reached or if they fail to perform the daily weighings. Regular physical visits at baseline, 3 months, and 6 months, alongside questionnaire assessments, will facilitate data collection via electronic case report forms.

The purpose of this study is to evaluate the treatment tools efficacy for childhood obesity treatment in Abu Dhabi. Furthermore, the study aims to establish non-inferiority compared to outcomes in Stockholm, Sweden (referred to as the "Stockholm cohort"), on 107 children and adolescents who were treated with the same treatment method between October 2018 and August 2019 (Clinicaltrials.gov ID: NCT04323215).

Enrollment: 70 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >6.0 and <16.0 years of age at inclusion
• Obesity according to International Obesity Task Force (IOTF)
• Willingness to participate in an obesity treatment proof of concept trial
• Family ability to communicate e.g. write and read messages in the mobile application
• Parents having a smart phone and an email address

Exclusion criteria

• Morbid obesity defined as iso-BMI>40 kg/m2 independently of age
• Endocrine disorders other than well controlled hypothyroidism
• Metabolic disorders of importance for weight control
• Treatment for depression and other psychiatric disorders during the last 6 months before inclusion
• Pharmacological treatment of importance for weight control
• Hypothalamic or monogenic obesity, e.g. syndromes and Mb Down
• Severe neuropsychiatric disorders that could affect study compliance
• Eating disorders requiring therapy during the last six months before inclusion or observed at the inclusion screening.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Digi-physical treatment in Abu Dhabi

Experimental group

Description:

The participants will receive digi-physical treatment using the Evira treatment tool. During the first 2 weeks, participants will receive information about the system and how to utilize the daily weighings and communication system. The families will be informed to perform lifestyle changes that they consider feasible in their specific living situations. The families will get one or two scales, depending on the family situation, and the phone applications installed in the parent's smart phones and, depending on the age of the child, in the child's phone as well. Clinical investigations will be completed and includes physical and abdominal examinations, weight, height, blood pressure and blood sampling. All participants will also be asked to answer questionnaires including quality of life, eating disorders, and treatment satisfaction.

Treatment:

Device: Digi-physical treatment tool