Early Life Intervention in Pediatrics Supported by E-health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Life-Style app.
- Who it may be relevant to
- Registry conditions: Adiposity, Childhood Obesity, Adolescent Obesity, Non-communicable Disease. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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).
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.
Interventions
- 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.
Primary outcome measures
- Change from baseline in TEI/TEE ratio (+22 Weeks) [Time frame: +22 weeks (Post intervention)]
- Change from baseline in TEI/TEE ratio (+48 weeks) [Time frame: +48 weeks (Follow-Up)]
Secondary outcome measures (12)
- Change in BMI z-score [Time frame: 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)]
- Change in body fat percentage [Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Change in waist circumference [Time frame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Cardiometabolic risk factor response: Change in 24-hours ambulatory blood pressure [Time frame: 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)]
- Cardiometabolic risk factor response: Change in plasma glucose levels [Time frame: 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)]
- Cardiometabolic risk factor response: Change in insulin levels [Time frame: 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)]
- Chronic low-level inflammatory biomarkers: Change in white blood cell count [Time frame: 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Switzerland · 1 center
- Department of Paediatrics, Inselspital, Bern University Hospital — Bern
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/s13063-025-0925 PMID 41254719
Identifiers
NCT: NCT06208345 · 2023-01136 · 5519