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

February 12, 2026 updated by: Insel Gruppe AG, University Hospital Bern

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Department of Paediatrics, Inselspital, Bern University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Christoph Saner, PhD, MD
        • Sub-Investigator:
          • Andrea Wyssen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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
  • Participation in another clinical trial targeting similar objectives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in TEI/TEE ratio (+22 Weeks)
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)
+22 weeks (Post intervention)
Change from baseline in TEI/TEE ratio (+48 weeks)
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)
+48 weeks (Follow-Up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiometabolic risk factor response: Change in 24-hours ambulatory blood pressure
Time Frame: Baseline, +22 weeks (Post intervention)
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
Time Frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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
Time Frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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
Time Frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Fasting lipid profiles are assessed
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Cardiometabolic risk factor response: Change in insulin levels
Time Frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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
Time Frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
HbA1c levels are assessed
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Chronic low-level inflammatory biomarkers: Change in white blood cell count
Time Frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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)
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.
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in parent-reported quality of life in children
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
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in BMI z-score
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
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in %>95th BMI-centile
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 %
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in body fat percentage
Time Frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
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
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
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in children's dietary habits I
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).
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
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).
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in children's physical activity I
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).
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)
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.
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in children's grip strength
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.
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptance and usability of the app (parent reported outcome)
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.
+22 weeks (Post intervention)
Acceptance and usability of the app
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.
During the intervention (20 weeks)
Exploratory: Metabolomic analysis of blood (biomarkers yet to be identified)
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)
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Exploratory: Proteomic analysis of blood (biomarkers yet to be identified)
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/)
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-01136 (KEK Bern)
  • 5519 (Other Identifier: DLF, Insel GRUPPE AG)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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