An interventional study of Digi-physical treatment tool in Childhood Obesity, Adolescent Obesity and Treatment Adherence, sponsored by Sheikh Shakhbout Medical City. Completed at 1 site in United Arab Emirates. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Sheikh Shakhbout Medical City · Not applicable, Interventional, and Treatment
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.
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).
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 70 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Sheikh Shakhbout Medical City is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Change in degree of obesity
Measured by BMI standard deviation score.
Time frame: From start of treatment to six months follow-up
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From start of treatment to six months follow-up
Number of physical visits
Visits to the clinic. Abu Dhabi cohort vs. Stockholm cohort
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: From start of treatment to six months follow-up
Drop-out rate
Number of drop-outs. Abu Dhabi cohort vs. Stockholm cohort
Time frame: 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
Time frame: From start of treatment to six months follow-up
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Sheikh Shakhbout Medical City