NCT Number: NCT06208345
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).
Interested in participating?
Request Info6 year–12 year
All sexes
Interventional
Not applicable
Bern, 3010, Switzerland
Location status: Recruiting
Andrea Wyssen, PhD
SUB_INVESTIGATOR
Christoph Saner, PhD, MD
CONTACT
Christoph Saner, PhD, MD
SUB_INVESTIGATOR
Matthias V Kopp, Prof, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Smartphone App
Time frame: +22 weeks (Post intervention)
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)
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: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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)
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)
The % bodyfat will be measured with a four-point bio-impedance device
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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)
24-hours ambulatory blood pressure measurements (ABPM) are assessed at baseline and post intervention.
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Carotid-femoral pulse wave velocity (PWV) to assess arterial stiffness
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Fasting plasma glucose levels are assessed for detection of insulin resistance
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Fasting lipid profiles are assessed
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Fasting insulin levels are measured for detection of insulin resistance
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
HbA1c levels are assessed
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
White blood cell count as inflammatory biomarker to assess chronic low-level inflammation.
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
High-sensitivity C-reactive protein (hs-CRP) as inflammatory biomarker to assess chronic low-level inflammation.
Time frame: 2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up
Parents reported outcomes. Dietary habits are assessed via app diary (e.g. frequency and composition of meals).
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Parents reported outcomes. Dietary habits are assessed via Children's Eating Behavior Questionnaire (CEBQ).
Time frame: 2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up
Parents reported outcomes. Physical activity is assessed via app diary (e.g., less sedentary time, increased physical activity).
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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)
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)
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: +22 weeks (Post intervention)
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.
Time frame: During the intervention (20 weeks)
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.
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Metabolomic analysis will be performed using the Nightingale Health's NMR-based metabolic biomarker profiling platform (https://research.nightingalehealth.com/biomarkers)
Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Proteomic analysis will be performed using the Olink Target 96 Cardiovascular panels (https://olink.com/products-services/target/cardiometabolic-panel/)
Contact information is provided by the study sponsor or research team.
Matthias V. Kopp, Prof. Dr.
CONTACT
Saner Christoph, PhD Dr.
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
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.
Acronym: ELIPSE-I
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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