Clinical trial NCT06665893: Local Proof of Concept of Evira in Abu Dhabi Study
Official title: Evaluating the Efficacy of the Evira Treatment Tool for Childhood Obesity Treatment - a 26- Week Single Arm Interventional Study in Abu Dhabi, United Arab Emirates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Adolescent Obesity
Treatment Adherence
Keywords: Digital health
Home-weighing
Obesity treatment
Treatment outcome
Lead sponsor: Sheikh Shakhbout Medical City
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Evira AB
First posted: 2024-10-30
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Children aged 6-15.9 years of age will be asked for participation. Participants included in the study will perform daily weighings at home and parents will be able to follow treatment closely in an application on their phone. Through a communication function in the application, families will be able to communicate in a fast and easy way with healthcare professionals at the clinic. The study duration is 6 months.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in degree of obesity
timeFrame: From start of treatment to six months follow-up
Secondary outcomes:
measure: Proportion of individuals reaching a clinically significant change in relative weight
timeFrame: From start of treatment to six months follow-up
measure: Proportion of individuals in obesity remission
timeFrame: From start of treatment to six months follow-up
measure: The use of the support tool - weighings
timeFrame: From start of treatment to six months follow-up
measure: The use of the support tool - text messages
timeFrame: From start of treatment to six months follow-up
measure: Number of physical visits
timeFrame: From start of treatment to six months follow-up
measure: Number of cancelation of physical visits
timeFrame: From start of treatment to six months follow-up
measure: Number of patients not showing up to physical visits
timeFrame: From start of treatment to six months follow-up
measure: Psycho-social health measures
timeFrame: From start of treatment to six months follow-up
measure: Drop-out rate
timeFrame: From start of treatment to six months follow-up
measure: Change in degree of obesity. Abu Dhabi cohort vs. Stockholm cohort
timeFrame: From start of treatment to six months follow-up
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Shakhbout Medical City
Study officials:
affiliation: Sheikh Shakhbout Medical City Abu Dhabi
name: Asma Deeb, Dr.
role: PRINCIPAL_INVESTIGATOR
References: