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).
ELIPSE-I represents a single-blind randomized controlled parallel-group clinical trial. In ELIPSE-I, 148 children, matched for sex, 6-12 years of age with a BMI \>97 centile based on national growth charts will be included. Children will be recruited at the children's university hospital and randomly (1:1) assigned to a control and intervention group. All participants receive treatment-as-usual (TAU), parents of participants in the intervention group additionally receive a smartphone application (lifestyle app) for 20 weeks. The app aims to promote healthy behavior through cognitive-behavioral impact factors (i.e., psychoeducation, goal setting), that are applied by a psychologist via structured feedback. Single-blinded assessments will be conducted at baseline, following the intervention period of 20 weeks, and at 6-month follow-up after the end of the intervention. The primary endpoint is reduction of the TEI/TEE ratio in children with obesity. Secondary endpoints in ELIPSE-I include lowering the severity of obesity, cardiometabolic risk factor improvement, reduction in chronic low-level inflammatory biomarkers, and improved children's quality of life. A further endpoint is acceptance and usability of the app.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
148
The 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.
Department of Paediatrics, Inselspital, Bern University Hospital
Bern, Switzerland
RECRUITINGChange 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)
Time frame: +22 weeks (Post intervention)
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)
Time frame: +48 weeks (Follow-Up)
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
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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 %
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in body fat percentage
The % bodyfat will be measured with a four-point bio-impedance device
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Cardiometabolic risk factor response: Change in 24-hours ambulatory blood pressure
24-hours ambulatory blood pressure measurements (ABPM) are assessed at baseline and post intervention.
Time frame: Baseline, +22 weeks (Post intervention)
Cardiometabolic risk factor response: Change in carotid-femoral pulse wave velocity
Carotid-femoral pulse wave velocity (PWV) to assess arterial stiffness
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Cardiometabolic risk factor response: Change in plasma glucose levels
Fasting plasma glucose levels are assessed for detection of insulin resistance
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Cardiometabolic risk factor response: Change in lipid levels
Fasting lipid profiles are assessed
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Cardiometabolic risk factor response: Change in insulin levels
Fasting insulin levels are measured for detection of insulin resistance
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Cardiometabolic risk factor response: Change in HbA1c levels
HbA1c levels are assessed
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Chronic low-level inflammatory biomarkers: Change in white blood cell count
White blood cell count as inflammatory biomarker to assess chronic low-level inflammation.
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Chronic low-level inflammatory biomarkers: Change in high-sensitivity C-reactive protein (hs-CRP)
High-sensitivity C-reactive protein (hs-CRP) as inflammatory biomarker to assess chronic low-level inflammation.
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in children's dietary habits I
Parents reported outcomes. Dietary habits are assessed via app diary (e.g. frequency and composition of meals).
Time frame: 2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up
Change in children's dietary habits II
Parents reported outcomes. Dietary habits are assessed via Children's Eating Behavior Questionnaire (CEBQ).
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in children's physical activity I
Parents reported outcomes. Physical activity is assessed via app diary (e.g., less sedentary time, increased physical activity).
Time frame: 2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up
Change in children's accelerometry-based physical activity (PA)
Physical activity is assessed using wrist-worn, triaxial accelerometers. Accelerometry-based physical activity (PA) is quantified as the average minutes per day spent in moderate- and vigorous-intensity activity, calculated over a 14-day wear period.
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in children's grip strength
Grip strength is related to hand grip strength measured with a dynamometer and the result is given in kg. This measure is divided by bodyweight to account for mass associated higher grip strength. the final metric will therefore be unitless as grip strength / bodyweight.
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in parent-reported quality of life in children
Parents reported outcomes. Quality of Life is assessed with the KidScreen-27 questionnaire assessing the five dimensions physical well-being, psychological well-being, relationships with parents and autonomy, social support and peers and school environment. The KidScreen-27 consists of 27 items of which each is answered on 5-point Likert type scales with higher scores representing better quality of life
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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