Early Life Intervention in Pediatrics Supported by E-health
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Life-Style app.
- Кому может быть актуально
- Состояния в реестре: Adiposity, Childhood Obesity, Adolescent Obesity, Non-communicable Disease. Базовые параметры: 6 лет — 12 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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.
Обзор
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).
Подробное описание
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.
Вмешательства
- Поведенческое 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.
Первичные конечные точки
- Change from baseline in TEI/TEE ratio (+22 Weeks) [Срок оценки: +22 weeks (Post intervention)]
- Change from baseline in TEI/TEE ratio (+48 weeks) [Срок оценки: +48 weeks (Follow-Up)]
Вторичные конечные точки (12)
- Change in BMI z-score [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Change in %>95th BMI-centile [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Change in body fat percentage [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Change in waist circumference [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Cardiometabolic risk factor response: Change in 24-hours ambulatory blood pressure [Срок оценки: Baseline, +22 weeks (Post intervention)]
- Cardiometabolic risk factor response: Change in carotid-femoral pulse wave velocity [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Cardiometabolic risk factor response: Change in plasma glucose levels [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Cardiometabolic risk factor response: Change in lipid levels [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Cardiometabolic risk factor response: Change in insulin levels [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Cardiometabolic risk factor response: Change in HbA1c levels [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Chronic low-level inflammatory biomarkers: Change in white blood cell count [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
- Chronic low-level inflammatory biomarkers: Change in high-sensitivity C-reactive protein (hs-CRP) [Срок оценки: Baseline, +22 weeks (Post intervention), +48 weeks (Follow-Up)]
Критерии участия
Критерии включения
- 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)
Критерии исключения
- Syndromic obesity
- Known congenital disease affecting musculo-skeletal, cardiac or pulmonary function
- Participation in another clinical trial targeting similar objectives
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
Швейцария · 1 центр
- Department of Paediatrics, Inselspital, Bern University Hospital — Bern
Публикации
- Koch A, Wyssen A, Haupt C, Hammelbeck J, van Dorland HA, Fluck CE, Latzin P, Saner C, Jakob J, Kaess M, Kopp MV. Early Life Intervention in Paediatrics Supported by E-Health (ELIPSE)-a coaching app for parents to reduce obesity and second-hand smoke exposure in children: study protocols for two parallel-group randomised controlled trials. Trials. 2025 Nov 18;26(1):520. doi: 10.1186/s13063-025-0925 PMID 41254719
Идентификаторы
NCT: NCT06208345 · 2023-01136 · 5519