The Evira European RCT (EurEvira)
Background
It is well established that pediatric obesity treatment outcome is far from optimal.A correlation has been found between visit frequency and weight outcome in 2017, by the US Preventive Task Force. They estimated that families with children living with obesity need at least 26 hours of contact with the behavioral support team per year to make it possible for the children to reach a clinically relevant reduction in degree of obesity. Such visit frequency is difficult to carry out due to its cost for society and places great demands on families. Consequently, it has been shown in a large review that a clinically relevant weight loss rarely is achieved in pediatric obesity treatment. When measuring weight development in children, there are several important aspects to consider. As children grow taller, they can gain weight (kg) and still reduce their degree of obesity (BMI SDS). Therefore, an outcome measure reflecting the relative weight change, e.g. body mass index standard deviation score (BMI SDS), should be used rather than the weight in kilograms. For many individuals, BMI SDS is difficult to understand, and it is therefore vital to facilitate the understanding of the treatment outcome.
A device named Evira®, a digital support system, has newly been developed and is based on four cornerstones; a) daily self- monitoring of weight, b) a mobile app used by parents, easily displaying objectively measured change in degree of obesity in relation to a prespecified treatment goal, c) a website on which clinicians view the same data as parents do in the mobile app and d) communication between clinicians and parents by text messages through the website and the mobile app (picture).
The feasibility of the support system has been evaluated in a small randomized study. The treatment effect observed in the 6-month randomized feasibility study was promising, and the treatment effect have further been confirmed in a 1-year pragmatical clinical trial, study where 107 children were treated Evira in combination with conventional life-style treatment with visits every third month.
Objectives
The aim of the present randomized controlled multicenter study is to evaluate the effects of adding Evira to the already locally used lifestyle treatment in several countries in Europe.
Primary outcome: Treatment effect will be evaluated by differences in change in relative weight (BMI SDS) between control and intervention groups after one year of treatment.
Secondary outcomes:
- Proportion of individuals reaching a clinically significant change in relative weight defined as a decrease of -0.25 BMI SDS units after six months and one year.
- Proportion of children in obesity remission after six months and one year of treatment.
- The effect of treatment in the control- and intervention group in relation to the number of physical visits.
- Treatment effect in relation to treatment compliance (cancelled visits, Evira weight measurements per week, communication failure).
- Treatment effect in relation to previously received treatment.
- Drop-out rate.
- Evaluate health benefits and costs.
- Negative side effects such as eating disorders, anxiety and depression.
- Quality of Life.
Impact
The digital device Evira has the potential to improve the modest effectiveness of present standard lifestyle treatment targeting childhood obesity. The treatment fosters family empowerment which is promising in terms og obtaining sustainable effects. For patients the treatment might reduce their risk of developing comorbidities to obesity (cancers, diabetes, cardiovascular diseases and psychiatric difficulties), and reduce their risk of school drop out, improve participation in social and working life, and longer life.
The health care will experience less patients with needs of treatment for several obesity comorbidities, including psychiatric disorders.
Period
2021-2025
Contact
Rønnaug Ødegård
Disseminations
Hagman E, Johansson L, Kollin C, et al. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond) 2022; 46(8): 1527-33.
Funding
Vinnova Sweeden
Collaboration
Karolinska Institutet, Lund University and Evira AB, Sweden.
Norwegian principal investigator: CORI