Early Life Intervention in Pediatrics Supported by E-health

NCT ID: NCT06208345

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2028-12-31

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).

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Treatment as usual (TAU) with Life-Style app

Children 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.

Group Type: EXPERIMENTAL

Life-Style app

Intervention Type: 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.

Treatment as usual (TAU)

The 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Smartphone App

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 newly 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias V. Kopp, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Michael Kaess, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland

Locations

Department of Paediatrics, Inselspital, Bern University Hospital

Bern, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Matthias V. Kopp, Prof. Dr.

Role: CONTACT

matthias.kopp@insel.ch

+41 31 66 4 13 51

Saner Christoph, PhD Dr.

Role: CONTACT

christoph.saner@insel.ch

+41 31 63 2 95 52

Facility Contacts

Christoph Saner, PhD, MD

Role: primary

christoph.saner@insel.ch

+41 31 63 2 95 52

Matthias V Kopp, Prof, MD

Role: backup

matthias.kopp@insel.ch

+41 31 66 4 13 51

Other Identifiers

2023-01136

Identifier Type: OTHER

Identifier Source: secondary_id

5519

Identifier Type: -

Identifier Source: org_study_id