Childhood obesity in early life contributes to the development of specific NCDs, i.e. adult obesity. Unhealthy diet and low level of physical activity are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of NCDs. Early preventive measures to improve lifestyle behavior are of utmost importance. The aim of ELIPSE-I is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering total energy intake/total energy expenditure (TEI/TEE) ratio in their children with BMI \>97 centile (ELIPSE-I).
German speaking parents
Any ethnic background/race
Children should live/grow-up in the same household as the parental participant
Children with an age- and sex-matched BMI >97 centile according to Swiss national growth charts
Syndromic obesity
Known congenital disease affecting musculo-skeletal, cardiac or pulmonary function
Participation in another clinical trial targeting similar objectives
Parallel
Life-Style app
BehavioralThe modules of the Life-Style app are introduced and unlocked sequentially during the first weeks of the intervention phase. Afterwards the modules are fully available. Duration and frequency of app-use is not limited. The parents are accompanied by a coach through the app, who gives regular structured feedback and individual inputs. The coach has access to all data collected in the app.
Change from baseline in TEI/TEE ratio (+22 Weeks)
TEI will be assessed by trained paediatric dietitians collecting 24-h dietary recalls on 3 days at baseline, post intervention and follow-up. TEE will be calculated using bio-impedance related body composition measures according to formulas provided by Pontzer et al. (2021; PMID: 34385400)
Change from baseline in TEI/TEE ratio (+48 weeks)
TEI will be assessed by trained paediatric dietitians collecting 24-h dietary recalls on 3 days at baseline, post intervention and follow-up. TEE will be calculated using bio-impedance related body composition measures according to formulas provided by Pontzer et al. (2021; PMID: 34385400)
Change in BMI z-score
BMI z-score will be calculated from height and weight data, considering age and sex, according to national and international representative growth charts
Change in %>95th BMI-centile
The %\>95th BMI-centile is a continuous measure starting from the 95th BMI-centile, and is a ratio of the individual's BMI divided by the relevant 95th BMI-centile for an age- and sex-matched individual multiplied by 100 %
Change in body fat percentage
The % bodyfat will be measured with a four-point bio-impedance device
Change in waist circumference
The waist circumference will be measured midway between iliac crest and lower end of ribs to the nearest 0.5 cm with a non-stretchable meter
Acceptance and usability of the app (parent reported outcome)
The usability of the app is assessed using the eHealth App Usability Questionnaire (MAUQ). The questionnaire measures usability on three subscales (ease of use, Interface and satisfaction, usefulness). The MAUQ questionnaire consists of 18 items with a score ranging from 1 to 7. Score 7 means a better result.
Acceptance and usability of the app
The usability of the app is measured by means of how often and how long the parents use the app. The acceptance of the app is measured by means of dropout rate.
Exploratory: Metabolomic analysis of blood (biomarkers yet to be identified)
Metabolomic analysis will be performed using the Nightingale Health's NMR-based metabolic biomarker profiling platform (https://research.nightingalehealth.com/biomarkers)
Exploratory: Proteomic analysis of blood (biomarkers yet to be identified)
Proteomic analysis will be performed using the Olink Target 96 Cardiovascular panels (https://olink.com/products-services/target/cardiometabolic-panel/)
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
University of Bern
Collaborator
