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Идёт набор NCT06311162

Early Life Intervention in Pediatrics Supported by E-health - SMOKE

Без фазы С лечением Smoking Reduction Asthma in Children Wheezing Non-Communicable Disease

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, Sham Comparator.
Кому может быть актуально
Состояния в реестре: Smoking Reduction, Asthma in Children, Wheezing, Non-Communicable Disease. Базовые параметры: до 5 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 II): Coaching Parents to Lower Second-hand Smoke Exposure in Children A Single-blind Randomized Controlled Parallel-group Clinical Trial

Обзор

Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .

Подробное описание

ELIPSE-II represents a single-blind randomized controlled parallel-group clinical trial. In total, 160 children, \<6 years of age with exposure to second-hand smoke at home will be included. Children will be recruited at the children's university hospital and in private practices in Bern, 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 exposure to second-hand smoke exposure assessed by urinary levels of cotinine. Secondary endpoints in ELIPSE-II include changes in parental smoking habits and effects of the intervention on infants' respiratory health. 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.
  • Другое Sham Comparator
    The parents get a flyer with information on second-hand smoke exposure and references to smoking cessation programs, and do not have an active app during the main intervention period.

Первичные конечные точки

  • Change from baseline in urinary levels of cotinine in children [Срок оценки: At 22 weeks after baseline (Post intervention)]
  • Change from baseline in urinary levels of cotinine in children [Срок оценки: At 48 weeks after baseline (Follow-Up)]
Вторичные конечные точки (1)
  • Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure [Срок оценки: During intervention (week 2-22), post intervention (week 22-23) and follow-up (week 48-49)]

Критерии участия

Критерии включения

  • Age: younger than 6 years
  • Exposed to second-hand smoke at home (at least one parent smoking)
  • German speaking parent
  • All sex and ethnic backgrounds
  • Signed informed consent form from parent
  • Children live/grow-up in the same household as the parental participant
  • Referred by a health care professional (e.g. physician, midwife, nurse, other professions)

Критерии исключения

  • Participation in another study/trial targeting similar outcomes
  • Participation in an active smoking cessation programme

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

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: NCT06311162 · 2023-01615

Первоисточники (государственные реестры)

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