Childhood ObesityNCT06665893
Local Proof of Concept of Evira in Abu Dhabi Study
A study testing Digi-physical treatment tool in people with Childhood Obesity and Adolescent Obesity, run by Sheikh Shakhbout Medical City at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Childhood Obesity, Adolescent Obesity, Treatment Adherence
- What is being tested?
- Digi-physical treatment tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jun 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Sheikh Shakhbout Medical City
Abu Dhabi
About this 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
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.
Read the 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).
- Conditions
- Childhood Obesity, Adolescent Obesity, Treatment Adherence
- Being tested
- Digi-physical treatment tool
- Keywords
- Digital health, Home-weighing, Obesity treatment, Treatment outcome
- Medical subject headings
- Pediatric Obesity, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digi-physical treatment toolDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Digi-physical treatment tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in degree of obesity
Measured by BMI standard deviation score.
Measured: From start of treatment to six months follow-up
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: From start of treatment to six months follow-up
Number of physical visits
Visits to the clinic. Abu Dhabi cohort vs. Stockholm cohort
Measured: 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
Measured: 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
Measured: 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).
Measured: From start of treatment to six months follow-up
Drop-out rate
Number of drop-outs. Abu Dhabi cohort vs. Stockholm cohort
Measured: 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
Measured: From start of treatment to six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Jun 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Shakhbout Medical City
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Evira AB
- Responsible party
- Sponsor
- Investigators
- Asma Deeb, Dr., Principal investigator, Sheikh Shakhbout Medical City Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665893
- Sponsor's protocol ID
- EviraUAE
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06665893
- Acronym / sponsor ID
- EviraUAE
- Conditions
- Childhood Obesity, Adolescent Obesity, Treatment Adherence
- Keywords
- Digital health, Home-weighing, Obesity treatment, Treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sheikh Shakhbout Medical CityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Evira AB
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digi-physical treatment in Abu Dhabi | Experimental | Device: Digi-physical treatment toolThe 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digi-physical treatment toolA 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. | Device | Digi-physical treatment in Abu Dhabi |
Primary outcome
Change in degree of obesity
Time frame: From start of treatment to six months follow-up
Measured by BMI standard deviation score.
10 secondary outcomes
Proportion of individuals reaching a clinically significant change in relative weight
Time frame: From start of treatment to six months follow-up
Proportion of individuals in obesity remission
Time frame: From start of treatment to six months follow-up
The use of the support tool - weighings
Time frame: From start of treatment to six months follow-up
The use of the support tool - text messages
Time frame: From start of treatment to six months follow-up
Number of physical visits
Time frame: From start of treatment to six months follow-up
Number of cancelation of physical visits
Time frame: From start of treatment to six months follow-up
Number of patients not showing up to physical visits
Time frame: From start of treatment to six months follow-up
Psycho-social health measures
Time frame: From start of treatment to six months follow-up
Drop-out rate
Time frame: From start of treatment to six months follow-up
Change in degree of obesity. Abu Dhabi cohort vs. Stockholm cohort
Time frame: From start of treatment to six months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma Deeb, Dr. principal investigator
Sheikh Shakhbout Medical City Abu Dhabi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digi-physical treatment tool in people with Childhood Obesity and Adolescent Obesity, run by Sheikh Shakhbout Medical City at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in degree of obesity (time frame: From start of treatment to six months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.