Early Life Intervention in Pediatrics Supported by E-health

Childhood Obesity Clinical Trial

— ELIPSE-I  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208345
• Other study ID #: 5519
• Secondary ID: 2023-01136
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Matthias V. Kopp, Prof. Dr.
• Phone: +41 31 66 4 13 51
• Email: matthias.kopp[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 31, 2028
• Est. primary completion date: July 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Adolescent Obesity
• Behavior, Eating
• Behavior, Health
• Childhood Obesity
• Life Style
• Non-communicable Disease
• Noncommunicable Diseases
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Paediatrics, Inselspital, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptance and usability of the app (parent reported outcome)	The usability of the app is assessed using the eHealth App Usability Questionnaire (MAUQ). The questionnaire measures usability on three subscales (ease of use, Interface and satisfaction, usefulness). The MAUQ questionnaire consists of 18 items with a score ranging from 1 to 7. Score 7 means a better result.	+22 weeks (Post intervention)
Other	Acceptance and usability of the app	The usability of the app is measured by means of how often and how long the parents use the app. The acceptance of the app is measured by means of dropout rate.	During the intervention (20 weeks)
Other	Exploratory: Metabolomic analysis of blood (biomarkers yet to be identified)	Metabolomic analysis will be performed using the Nightingale Health's NMR-based metabolic biomarker profiling platform (https://research.nightingalehealth.com/biomarkers)	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Other	Exploratory: Proteomic analysis of blood (biomarkers yet to be identified)	Proteomic analysis will be performed using the Olink Target 96 Cardiovascular panels (https://olink.com/products-services/target/cardiometabolic-panel/)	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Primary	Change from baseline in TEI/TEE ratio	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)	+22 weeks (Post intervention)
Primary	Change from baseline in TEI/TEE ratio	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)	+48 weeks (Follow-Up)
Secondary	Change in BMI z-score	BMI z-score will be calculated from height and weight data, considering age and sex, according to national and international representative growth charts	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Change in %>95th BMI-centile	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 %	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Change in body fat percentage	The % bodyfat will be measured with a four-point bio-impedance device	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Change in waist circumference	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	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Cardiometabolic risk factor response: Change in 24-hours ambulatory blood pressure	24-hours ambulatory blood pressure measurements (ABPM) are assessed at baseline and post intervention.	Baseline, +22 weeks (Post intervention)
Secondary	Cardiometabolic risk factor response: Change in carotid-femoral pulse wave velocity	Carotid-femoral pulse wave velocity (PWV) to assess arterial stiffness	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Cardiometabolic risk factor response: Change in plasma glucose levels	Fasting plasma glucose levels are assessed for detection of insulin resistance	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Cardiometabolic risk factor response: Change in lipid levels	Fasting lipid profiles are assessed	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Cardiometabolic risk factor response: Change in insulin levels	Fasting insulin levels are measured for detection of insulin resistance	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Cardiometabolic risk factor response: Change in HbA1c levels	HbA1c levels are assessed	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Chronic low-level inflammatory biomarkers: Change in white blood cell count	White blood cell count as inflammatory biomarker to assess chronic low-level inflammation.	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Chronic low-level inflammatory biomarkers: Change in high-sensitivity C-reactive protein (hs-CRP)	High-sensitivity C-reactive protein (hs-CRP) as inflammatory biomarker to assess chronic low-level inflammation.	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)
Secondary	Change in children's dietary habits	Parents reported outcomes. Dietary habits are assessed via app diary (e.g. frequency and composition of meals).	2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up
Secondary	Change in children's physical activity	Parents reported outcomes. Physical activity is assessed via app diary (e.g., less sedentary time, increased physical activity).	2-weeks before intervention, during intervention (20 weeks), 2-weeks after intervention, and 2-weeks at 6 months follow-up
Secondary	Change in parent-reported quality of life in children	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	Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)