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| ID | Type | Description | Link |
|---|---|---|---|
| 5519 | Other Identifier | DLF, Insel GRUPPE AG |
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| Name | Class |
|---|---|
| University of Bern | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual (TAU) with Life-Style app | Experimental | Children in the intervention group receive treatment as usual (TAU) and the parents receive a smartphone app during the main intervention period of 20 weeks. The app (life-style app) aims to promote healthy behaviour through cognitive-behavioural impact factors. |
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| Treatment as usual (TAU) | No Intervention | The children in the control group only receive treatment-as-usual (TAU) and the parents do not have an active app during the main intervention period of 20 weeks. TAU includes lifestyle behaviour counselling, dietary counselling by specialized dieticians, prescriptions for physiotherapy, as provided at the last clinical visit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life-Style app | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | +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) | +48 weeks (Follow-Up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) |
| Change in %>95th BMI-centile |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | +22 weeks (Post intervention) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthias V. Kopp, Prof. Dr. | Contact | +41 31 66 4 13 51 | matthias.kopp@insel.ch | |
| Saner Christoph, PhD Dr. | Contact | +41 31 63 2 95 52 | christoph.saner@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Matthias V. Kopp, Prof. Dr. | Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland | Principal Investigator |
| Michael Kaess, Prof. Dr. | Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics, Inselspital, Bern University Hospital | Recruiting | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41254719 | Derived | Koch A, Wyssen A, Haupt C, Hammelbeck J, van Dorland HA, Fluck CE, Latzin P, Saner C, Jakob J, Kaess M, Kopp MV. Early Life Intervention in Paediatrics Supported by E-Health (ELIPSE)-a coaching app for parents to reduce obesity and second-hand smoke exposure in children: study protocols for two parallel-group randomised controlled trials. Trials. 2025 Nov 18;26(1):520. doi: 10.1186/s13063-025-09251-5. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| D000073296 | Noncommunicable Diseases |
| D005247 | Feeding Behavior |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Single-blind randomized controlled parallel-group clinical trial
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The treating physicians are kept blind to the treatment allocation.
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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 % |
| 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 | 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 | 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. | 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 | 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 | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) |
| Cardiometabolic risk factor response: Change in lipid levels | Fasting lipid profiles are assessed | 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 | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) |
| Cardiometabolic risk factor response: Change in HbA1c levels | HbA1c levels are assessed | 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. | 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. | 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). | 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). | 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). | 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. | 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. | 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 | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) |
| 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. | During the intervention (20 weeks) |
| 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) | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) |
| 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/) | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D001522 | Behavior, Animal |
| D001519 | Behavior |