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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change from baseline in TEI/TEE ratio (+22 Weeks)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The treating physicians are kept blind to the treatment allocation.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Syndromic obesity
- •Known congenital disease affecting musculo-skeletal, cardiac or pulmonary function
- •Participation in another clinical trial targeting similar objectives
研究组 & 干预措施
Treatment as usual (TAU) with 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.
干预措施: Life-Style app (Behavioral)
Treatment as usual (TAU)
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.
结局指标
主要结局
Change from baseline in TEI/TEE ratio (+22 Weeks)
时间窗: +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)
Change from baseline in TEI/TEE ratio (+48 weeks)
时间窗: +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)
次要结局
- Change in BMI z-score(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Change in %>95th BMI-centile(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Change in body fat percentage(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Cardiometabolic risk factor response: Change in plasma glucose levels(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Change in waist circumference(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Cardiometabolic risk factor response: Change in 24-hours ambulatory blood pressure(Baseline, +22 weeks (Post intervention))
- Cardiometabolic risk factor response: Change in carotid-femoral pulse wave velocity(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Cardiometabolic risk factor response: Change in lipid levels(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Chronic low-level inflammatory biomarkers: Change in white blood cell count(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Change in parent-reported quality of life in children(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Cardiometabolic risk factor response: Change in insulin levels(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Cardiometabolic risk factor response: Change in HbA1c levels(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Chronic low-level inflammatory biomarkers: Change in high-sensitivity C-reactive protein (hs-CRP)(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- 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)
- Change in children's dietary habits II(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- 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)
- Change in children's accelerometry-based physical activity (PA)(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))
- Change in children's grip strength(Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up))