Adolescent Obesity, Childhood Obesity, Treatment Adherence
Conditions
Keywords
Digital health, Home-weighing, Obesity treatment, Treatment outcome
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).
Interventions
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.
Sponsors
Karolinska Institutet
Evira AB
Sheikh Shakhbout Medical City
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in degree of obesity | From start of treatment to six months follow-up | Measured by BMI standard deviation score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of individuals in obesity remission | From start of treatment to six months follow-up | Obesity remission defined as no longer having obesity class 1. Abu Dhabi cohort vs. Stockholm cohort |
| The use of the support tool - weighings | From start of treatment to six months follow-up | Number of weighings/week. Abu Dhabi cohort vs. Stockholm cohort |
| The use of the support tool - text messages | From start of treatment to six months follow-up | Number of weighings/week. Abu Dhabi cohort vs. Stockholm cohort |
| Number of physical visits | From start of treatment to six months follow-up | Visits to the clinic. Abu Dhabi cohort vs. Stockholm cohort |
| Proportion of individuals reaching a clinically significant change in relative weight | From start of treatment to six months follow-up | 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 |
| Number of patients not showing up to physical visits | From start of treatment to six months follow-up | Visits to the clinic. Abu Dhabi cohort vs. Stockholm cohort |
| Psycho-social health measures | From start of treatment to six months follow-up | 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). |
| Drop-out rate | From start of treatment to six months follow-up | Number of drop-outs. Abu Dhabi cohort vs. Stockholm cohort |
| Change in degree of obesity. Abu Dhabi cohort vs. Stockholm cohort | From start of treatment to six months follow-up | Measured by BMI standard deviation score |
| Number of cancelation of physical visits | From start of treatment to six months follow-up | Visits to the clinic. Abu Dhabi cohort vs. Stockholm cohort |
Countries
United Arab Emirates
Outcome results
None listed