Clinical trial

Early Life Intervention in Pediatrics Supported by E-health

Recruiting now · Not applicable · 1 countries · Registry ID NCT06208345

Recruiting nowNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 12 Years

SexAll

Healthy volunteersNot accepted

ConditionAdiposity, Childhood Obesity, Adolescent Obesity, Non-communicable Disease, Life Style, Behavior, Eating, Behavior, Health

Full registry 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

Treatments and study arms

Life-Style app

Behavioral

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 outcomes

Change from baseline in TEI/TEE ratio (+22 Weeks)+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)

Change from baseline in TEI/TEE ratio (+48 weeks)+48 weeks (Follow-Up)

Study locations

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Department of Paediatrics, Inselspital, Bern University Hospital🇨🇭 Bern, Switzerland

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Christoph Saner, PhD, MDContact

Email · Call +41 31 63 2 95 52

Matthias V Kopp, Prof, MDContact

Email · Call +41 31 66 4 13 51

Christoph Saner, PhD, MDSub Investigator