Early Life Intervention in Pediatrics Supported by E-health (ELIPSE-I)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

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

Treatments: Behavioral: Life-Style app

Study type: Interventional

Funder types: Other

Identifiers

NCT06208345

5519

2023-01136 (Other Identifier)

Details and patient eligibility

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).

Full 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.

Enrollment: 148 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups

Treatment as usual (TAU) with Life-Style app

Experimental group

Description:

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.

Treatment:

Behavioral: Life-Style app

Treatment as usual (TAU)

No Intervention group

Description:

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.