Early Life Intervention in Pediatrics Supported by E-health

Not Applicable

Recruiting

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

• Registration Number: NCT06208345
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-17
• Study Start: 2024-02-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20
• Primary Completion: 2028-07-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual (TAU) with Life-Style app	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in TEI/TEE ratio	+48 weeks (Follow-Up)	TEI will be assessed by trained paediatric dietitians collecting 24-h dietary recalls on 3 days within a 1-month interval 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)

Secondary Outcome Measures

Name	Time	Method
Change in BMI z-score	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	BMI z-score will be calculated from height and weight data, considering age and sex, according to national and international representative growth charts
Change in children's dietary habits	2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up	Parents reported outcomes. Dietary habits are assessed via app diary (e.g. frequency and composition of meals).
Change in %>95th BMI-centile	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	The %\>95th BMI-centile is a continuous measure starting from the 95th BMI-centile, and is a ratio of the individual's BMI divided by the relevant 95th BMI-centile for an age- and sex-matched individual multiplied by 100 %
Change in children's physical activity	2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up	Parents reported outcomes. Physical activity is assessed via app diary (e.g., less sedentary time, increased physical activity).
Change in body fat percentage	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	The % bodyfat will be measured with a four-point bio-impedance device
Cardiometabolic risk factor response: Change in plasma glucose levels	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	Fasting plasma glucose levels are assessed for detection of insulin resistance
Change in waist circumference	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	The waist circumference will be measured midway between iliac crest and lower end of ribs to the nearest 0.5 cm with a non-stretchable meter
Cardiometabolic risk factor response: Change in 24-hours ambulatory blood pressure	Baseline, +22 weeks (Post intervention)	24-hours ambulatory blood pressure measurements (ABPM) are assessed at baseline and post intervention.
Cardiometabolic risk factor response: Change in carotid-femoral pulse wave velocity	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	Carotid-femoral pulse wave velocity (PWV) to assess arterial stiffness
Cardiometabolic risk factor response: Change in lipid levels	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	Fasting lipid profiles are assessed
Chronic low-level inflammatory biomarkers: Change in white blood cell count	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	White blood cell count as inflammatory biomarker to assess chronic low-level inflammation.
Change in parent-reported quality of life in children	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	Parents reported outcomes. Quality of Life is assessed with the KidScreen-27 questionnaire assessing the five dimensions physical well-being, psychological well-being, relationships with parents and autonomy, social support and peers and school environment. The KidScreen-27 consists of 27 items of which each is answered on 5-point Likert type scales with higher scores representing better quality of life
Cardiometabolic risk factor response: Change in insulin levels	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	Fasting insulin levels are measured for detection of insulin resistance
Cardiometabolic risk factor response: Change in HbA1c levels	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	HbA1c levels are assessed
Chronic low-level inflammatory biomarkers: Change in high-sensitivity C-reactive protein (hs-CRP)	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)	High-sensitivity C-reactive protein (hs-CRP) as inflammatory biomarker to assess chronic low-level inflammation.

Trial Locations

Locations (1)

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