RecruitingNot ApplicableNCT06208345

Early Life Intervention in Pediatrics Supported by E-health

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.


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

148 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria6

  • 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 Criteria3

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

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Interventions

BEHAVIORALLife-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.


Locations(1)

Department of Paediatrics, Inselspital, Bern University Hospital

Bern, Switzerland

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NCT06208345


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