Local Proof of Concept of Evira in Abu Dhabi Study

NCT06665893 | Completed DMC

• 1 other identifier: EviraUAE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity; Adolescent Obesity; Treatment Adherence

Keywords

Digital health; Home-weighing; Obesity treatment; Treatment outcome

Outcome Measures

Primary Outcomes (1)

• Change in degree of obesity

  Measured by BMI standard deviation score.

  From start of treatment to six months follow-up

Secondary Outcomes (10)

• Proportion of individuals reaching a clinically significant change in relative weight

  From start of treatment to six months follow-up

• Proportion of individuals in obesity remission

  From start of treatment to six months follow-up

• The use of the support tool - weighings

  From start of treatment to six months follow-up

• The use of the support tool - text messages

  From start of treatment to six months follow-up

• Number of physical visits

  From start of treatment to six months follow-up

Study Arms (1)

Digi-physical treatment in Abu Dhabi

EXPERIMENTAL

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

Interventions

Digi-physical treatment tool DEVICE

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.

Digi-physical treatment in Abu Dhabi

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sheikh Shakhbout Medical City: lead
• Karolinska Institutet: collaborator
• Evira AB: collaborator

Study Sites (1)

Sheikh Shakhbout Medical City

Abu Dhabi, United Arab Emirates

Location

MeSH Terms

Conditions

Pediatric Obesity; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Asma Deeb, Dr.

  Sheikh Shakhbout Medical City Abu Dhabi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

AE (1)