Early Life Intervention in Pediatrics Supported by E-health
ELIPSE-I
2 other identifiers
interventional
148
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedStudy Start
First participant enrolled
February 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 18, 2026
February 1, 2026
4.5 years
December 19, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
+22 weeks (Post intervention)
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)
+48 weeks (Follow-Up)
Secondary Outcomes (18)
Change in BMI z-score
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in %>95th BMI-centile
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in body fat percentage
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Change in waist circumference
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Cardiometabolic risk factor response: Change in 24-hours ambulatory blood pressure
Baseline, +22 weeks (Post intervention)
- +13 more secondary outcomes
Other Outcomes (4)
Acceptance and usability of the app (parent reported outcome)
+22 weeks (Post intervention)
Acceptance and usability of the app
During the intervention (20 weeks)
Exploratory: Metabolomic analysis of blood (biomarkers yet to be identified)
Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
- +1 more other outcomes
Study Arms (2)
Treatment as usual (TAU) with Life-Style app
EXPERIMENTALChildren 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.
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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Syndromic obesity
- Known congenital disease affecting musculo-skeletal, cardiac or pulmonary function
- Participation in another clinical trial targeting similar objectives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insel Gruppe AG, University Hospital Bernlead
- University of Berncollaborator
Study Sites (1)
Department of Paediatrics, Inselspital, Bern University Hospital
Bern, 3010, Switzerland
Related Publications (1)
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.
PMID: 41254719DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Masking Details
- The treating physicians are kept blind to the treatment allocation.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2023
First Posted
January 17, 2024
Study Start
February 16, 2024
Primary Completion (Estimated)
July 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share