Adiposity, Adolescent Obesity, Behavior, Eating, Behavior, Health, Childhood Obesity, Life Style, Non-communicable Disease
Conditions
Keywords
Adiposity, Children, Adolescents, Prevention, eHealth
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.
Interventions
BEHAVIORALLife-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.
Sponsors
Insel Gruppe AG, University Hospital Bern
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The treating physicians are kept blind to the treatment allocation.
Intervention model description
Single-blind randomized controlled parallel-group clinical trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in TEI/TEE ratio (+48 weeks) | +48 weeks (Follow-Up) | TEI will be assessed by trained paediatric dietitians collecting 24-h dietary recalls on 3 days 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) |
| Change from baseline in TEI/TEE ratio (+22 Weeks) | +22 weeks (Post intervention) | TEI will be assessed by trained paediatric dietitians collecting 24-h dietary recalls on 3 days 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 plasma glucose levels | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) | Fasting plasma glucose levels are assessed for detection of insulin resistance |
| Cardiometabolic risk factor response: Change in lipid levels | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) | Fasting lipid profiles are assessed |
| 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 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. |
| 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. |
| Change in children's dietary habits I | 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 children's dietary habits II | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) | Parents reported outcomes. Dietary habits are assessed via Children's Eating Behavior Questionnaire (CEBQ). |
| Change in children's physical activity I | 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 children's accelerometry-based physical activity (PA) | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) | Physical activity is assessed using wrist-worn, triaxial accelerometers. Accelerometry-based physical activity (PA) is quantified as the average minutes per day spent in moderate- and vigorous-intensity activity, calculated over a 14-day wear period. |
| Change in children's grip strength | Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up) | Grip strength is related to hand grip strength measured with a dynamometer and the result is given in kg. This measure is divided by bodyweight to account for mass associated higher grip strength. the final metric will therefore be unitless as grip strength / bodyweight. |
| 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 |
| 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 |
| 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 |
Countries
Switzerland
Contacts
CONTACTMatthias V. Kopp, Prof. Dr.
CONTACTSaner Christoph, PhD Dr.
PRINCIPAL_INVESTIGATORMatthias V. Kopp, Prof. Dr.
Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
PRINCIPAL_INVESTIGATORMichael Kaess, Prof. Dr.
Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland
Outcome results
None listed