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AdiposityELIPSE-INCT06208345

Early Life Intervention in Pediatrics Supported by E-health

A study testing Life-Style app in people with Adiposity and Childhood Obesity, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Adiposity, Childhood Obesity, Adolescent Obesity
What is being tested?
Life-Style app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteSwitzerland
Study dates
16 Feb 2024to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • Syndromic obesity
  • Known congenital disease affecting musculo-skeletal, cardiac or pulmonary function
  • Participation in another clinical trial targeting similar objectives

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Switzerland1 site, 1 recruiting

  • Department of Paediatrics, Inselspital, Bern University Hospital

    Bern, 3010

    Christoph Saner, PhD, MD, +41 31 63 2 95 52, christoph.saner@insel.ch

    Matthias V Kopp, Prof, MD, +41 31 66 4 13 51, matthias.kopp@insel.ch

    Recruiting

Other trials in Switzerland

About this study

Official 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).

Read the 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.

Being tested
Life-Style app
Keywords
Adiposity, Children, Adolescents, Prevention, eHealth
Medical subject headings
Obesity, Pediatric Obesity, Noncommunicable Diseases, Feeding Behavior, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Life-Style appBehavioural

    Also called Smartphone 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.

Study groups in NCT06208345
Study groupRoleWhat they receive
Treatment as usual (TAU) with Life-Style appExperimentalChildren 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.
Receives: Behavioral: Life-Style app
Treatment as usual (TAU)No interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: +22 weeks (Post intervention)

  2. 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)

    Measured: +48 weeks (Follow-Up)

Secondary outcomes (18)

  1. 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

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  2. 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 %

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  3. Change in body fat percentage

    The % bodyfat will be measured with a four-point bio-impedance device

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  4. 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

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  5. 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.

    Measured: Baseline, +22 weeks (Post intervention)

  6. Cardiometabolic risk factor response: Change in carotid-femoral pulse wave velocity

    Carotid-femoral pulse wave velocity (PWV) to assess arterial stiffness

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  7. Cardiometabolic risk factor response: Change in plasma glucose levels

    Fasting plasma glucose levels are assessed for detection of insulin resistance

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  8. Cardiometabolic risk factor response: Change in lipid levels

    Fasting lipid profiles are assessed

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  9. Cardiometabolic risk factor response: Change in insulin levels

    Fasting insulin levels are measured for detection of insulin resistance

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  10. Cardiometabolic risk factor response: Change in HbA1c levels

    HbA1c levels are assessed

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  11. Chronic low-level inflammatory biomarkers: Change in white blood cell count

    White blood cell count as inflammatory biomarker to assess chronic low-level inflammation.

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  12. 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.

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  13. Change in children's dietary habits I

    Parents reported outcomes. Dietary habits are assessed via app diary (e.g. frequency and composition of meals).

    Measured: 2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up

  14. Change in children's dietary habits II

    Parents reported outcomes. Dietary habits are assessed via Children's Eating Behavior Questionnaire (CEBQ).

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  15. 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).

    Measured: 2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up

  16. 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.

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  17. 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.

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

  18. 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

    Measured: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start16 Feb 2024
  3. Primary completion30 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind randomized controlled parallel-group clinical trial
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06208345
Sponsor's protocol ID
2023-01136
Other IDs
5519, 2023
Acronym
ELIPSE-I
Status last verified
Feb 2026
First submitted
19 Dec 2023
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41254719

Questions about this trial

What is this clinical trial studying?

A study testing Life-Style app in people with Adiposity and Childhood Obesity, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matthias V. Kopp, Prof. Dr. (+41 31 66 4 13 51, matthias.kopp@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in TEI/TEE ratio (+22 Weeks) (time frame: +22 weeks (Post intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06208345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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