Clinical trial NCT06208345: Early Life Intervention in Pediatrics Supported by E-health
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adiposity
Childhood Obesity
Adolescent Obesity
Non-communicable Disease
Life Style
Behavior, Eating
Behavior, Health
Keywords: Adiposity
Children
Adolescents
Prevention
eHealth
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2024-01-17
Enrollment: 148
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized controlled parallel-group clinical trial
Primary purpose: PREVENTION

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.

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
* Insufficient knowledge of German language
* Participation in another clinical trial targeting similar objectives

Primary outcomes:
measure: Change from baseline in TEI/TEE ratio
timeFrame: +22 weeks (Post intervention)
measure: Change from baseline in TEI/TEE ratio
timeFrame: +48 weeks (Follow-Up)
Secondary outcomes:
measure: Change in BMI z-score
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Change in %>95th BMI-centile
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Change in body fat percentage
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Change in waist circumference
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Cardiometabolic risk factor response: Change in 24-hours ambulatory blood pressure
timeFrame: Baseline, +22 weeks (Post intervention)
measure: Cardiometabolic risk factor response: Change in carotid-femoral pulse wave velocity
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Cardiometabolic risk factor response: Change in plasma glucose levels
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Cardiometabolic risk factor response: Change in lipid levels
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Cardiometabolic risk factor response: Change in insulin levels
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Cardiometabolic risk factor response: Change in HbA1c levels
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Chronic low-level inflammatory biomarkers: Change in white blood cell count
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Chronic low-level inflammatory biomarkers: Change in high-sensitivity C-reactive protein (hs-CRP)
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Change in children's dietary habits
timeFrame: 2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up
measure: Change in children's physical activity
timeFrame: 2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up
measure: Change in parent-reported quality of life in children
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Other outcomes:
measure: Acceptance and usability of the app (parent reported outcome)
timeFrame: +22 weeks (Post intervention)
measure: Acceptance and usability of the app
timeFrame: During the intervention (20 weeks)
measure: Exploratory: Metabolomic analysis of blood (biomarkers yet to be identified)
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
measure: Exploratory: Proteomic analysis of blood (biomarkers yet to be identified)
timeFrame: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Locations:
city: Bern
country: Switzerland
facility: Department of Paediatrics, Inselspital, Bern University Hospital
Study officials:
affiliation: Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
name: Matthias V. Kopp, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland
name: Michael Kaess, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: