Childhood Obesity Clinical Trial
— ELIPSE-IOfficial title:
Early Life Intervention in Pediatrics Supported by E-health (ELIPSE I): Coaching Parents to Lower Obesity in Children. A Single-blind Randomized Controlled Parallel-group Clinical Trial.
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).
Status | Recruiting |
Enrollment | 148 |
Est. completion date | December 31, 2028 |
Est. primary completion date | July 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - 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 - Children who newly attend the outpatient weight management clinic at the Division of Pediatric Endocrinology at the University Children's Hospital Bern - Signed informed consent form from parent(s) Exclusion Criteria: - Syndromic obesity - Known congenital disease affecting musculo-skeletal, cardiac or pulmonary function - Insufficient knowledge of German language - Participation in another clinical trial targeting similar objectives |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Paediatrics, Inselspital, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern | University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | |
Other | 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) | |
Other | 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) | |
Other | 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) | |
Primary | Change from baseline in TEI/TEE ratio | TEI will be assessed by trained paediatric dietitians collecting 24-h dietary recalls on 3 days within a 1-month interval 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) | |
Primary | Change from baseline in TEI/TEE ratio | TEI will be assessed by trained paediatric dietitians collecting 24-h dietary recalls on 3 days within a 1-month interval 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) | |
Secondary | 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) | |
Secondary | 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 % | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Cardiometabolic risk factor response: Change in lipid levels | Fasting lipid profiles are assessed | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) | |
Secondary | 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) | |
Secondary | Cardiometabolic risk factor response: Change in HbA1c levels | HbA1c levels are assessed | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Change in children's dietary habits | 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 | |
Secondary | Change in children's physical activity | 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 | |
Secondary | 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) |
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