Early Life Intervention in Pediatrics Supported by E-health (ELIPSE-I)

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).

Study Overview

• Status: Recruiting
• Conditions: Childhood Obesity; Adolescent Obesity; Adiposity; Non-communicable Disease; Life Style; Behavior, Health; Behavior, Eating
• Intervention / Treatment: Behavioral: Life-Style app

Detailed Description

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
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthias V. Kopp, Prof. Dr.; Phone Number: +41 31 66 4 13 51; Email: matthias.kopp@insel.ch
• Study Contact Backup: Name: Saner Christoph, PhD Dr.; Phone Number: +41 31 63 2 95 52; Email: christoph.saner@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Paediatrics, Inselspital, Bern University Hospital
    • Contact: Christoph Saner, PhD, MD; Phone Number: +41 31 63 2 95 52; Email: christoph.saner@insel.ch
    • Contact: Matthias V Kopp, Prof, MD; Phone Number: +41 31 66 4 13 51; Email: matthias.kopp@insel.ch
    • Sub-Investigator: Christoph Saner, PhD, MD
    • Sub-Investigator: Andrea Wyssen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment as usual (TAU) with Life-Style app; 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.	Behavioral: Life-Style app; 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
No Intervention: Treatment as usual (TAU); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 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
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)
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	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)

Other Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: University of Bern
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Children; Prevention; eHealth; Adiposity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Noncommunicable Diseases
• Other Study ID Numbers: 5519; 2023-01136 (Other Identifier: KEK Bern)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No