Local Proof of Concept of Evira in Abu Dhabi Study

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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity; Adolescent Obesity; Treatment Adherence
• Intervention / Treatment: Device: Digi-physical treatment tool

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).

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Sheikh Shakhbout Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Digi-physical treatment in Abu Dhabi; 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.

Device: Digi-physical treatment tool; A support tool named Evira will be used to provide behavioral treatment. Through daily weightings at home using a special designed scale, which sends data directly to an application on the parents phone and to a clinic homepage, the child's weight development can be easily monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in degree of obesity	Measured by BMI standard deviation score.	From start of treatment to six months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of individuals reaching a clinically significant change in relative weight	Proportion of individuals reaching a clinically significant change in relative weight defined as a decrease of -0.20 BMI SDS units. Abu Dhabi cohort vs. Stockholm cohort	From start of treatment to six months follow-up
Proportion of individuals in obesity remission	Obesity remission defined as no longer having obesity class 1. Abu Dhabi cohort vs. Stockholm cohort	From start of treatment to six months follow-up
The use of the support tool - weighings	Number of weighings/week. Abu Dhabi cohort vs. Stockholm cohort	From start of treatment to six months follow-up
The use of the support tool - text messages	Number of weighings/week. Abu Dhabi cohort vs. Stockholm cohort	From start of treatment to six months follow-up
Number of physical visits	Visits to the clinic. Abu Dhabi cohort vs. Stockholm cohort	From start of treatment to six months follow-up
Number of cancelation of physical visits	Visits to the clinic. Abu Dhabi cohort vs. Stockholm cohort	From start of treatment to six months follow-up
Number of patients not showing up to physical visits	Visits to the clinic. Abu Dhabi cohort vs. Stockholm cohort	From start of treatment to six months follow-up
Psycho-social health measures	Psycho-social health assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. The PROMIS questionnaire is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The output from a PROMIS score is represented as a T score. Higher scores indicate more of the domain being measured (e.g., more fatigue, more pain).	From start of treatment to six months follow-up
Drop-out rate	Number of drop-outs. Abu Dhabi cohort vs. Stockholm cohort	From start of treatment to six months follow-up
Change in degree of obesity. Abu Dhabi cohort vs. Stockholm cohort	Measured by BMI standard deviation score	From start of treatment to six months follow-up

Collaborators and Investigators

• Sponsor: Sheikh Shakhbout Medical City
• Collaborators: Karolinska Institutet; Evira AB
• Investigators: Principal Investigator: Asma Deeb, Dr., Sheikh Shakhbout Medical City Abu Dhabi

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Treatment outcome; Digital health; Obesity treatment; Home-weighing
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: EviraUAE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data for the main outcome will be available upon date of scientific publications. To preserve individual case and anonymity, more detailed data and additional variables will be available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No