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Идёт набор NCT06793930

A Tailored, Optimised, and Person-centred Programme to Promote Lifestyle Modification in People With Metabolic Syndrome

Без фазы С лечением Metabolic Syndrome Primary Prevention of Atherosclerotic Cardiovascular 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: A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification, Brief advice.
Кому может быть актуально
Состояния в реестре: Metabolic Syndrome, Primary Prevention of Atherosclerotic Cardiovascular Disease. Базовые параметры: от 18 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
Гонконг
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

The Effects of a Tailored, Optimised, and Person-centred Critical Pathway to Promote Lifestyle Modification in People With Metabolic Syndrome: A Mixed-methods Study

Обзор

This is a mixed-methods study comprising a 2-arm randomised controlled trial and a qualitative study. This study aims to evaluate the effects of a lifestyle modification on the control of metabolic syndrome, with assessments measured at baseline, immediately at the end of the active phase of intervention (12 weeks) and 8 weeks thereafter (20 weeks). It will be conducted in multiple community centres in Hong Kong. Individuals fulfilling the following eligibility criteria will be recruited: 1\) Chinese people with metabolic syndrome defined by the 'Harmonising the metabolic syndrome' (HMS) criteria by three or more abnormal findings out of five components (i.e., raised blood pressure, raised triglycerides, lowered HDL, raised fasting blood glucose, and central obesity)\[1\]; 2) aged ≥18; 3) community-dwelling; 4) independent in daily living, and 5) possessed a digital device with internet connection. Participants will be randomly allocated in a 1:1 ratio to receive the TOP critical pathway (intervention group) or once-off brief lifestyle advice (control group). Evaluation outcomes will be measured at baseline (T0), 12 weeks (T1) and 20 weeks (T2) thereafter. The outcome assessment includes Health-Promoting Lifestyle Profile-II (HPLP-II), reversal of metabolic syndrome, defining characteristics of metabolic syndrome (body mass index, systolic and diastolic blood pressure, triglycerides, high-density lipoprotein, fasting blood glucose and waist circumference) and the 12-item Short-Form Health Survey version 2 (SF-12v2). Triglycerides, high-density lipoprotein and fasting blood glucose will be measured using a portable point-of-care analyser.

Вмешательства

  • Поведенческое A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification
    The TOP-S programme is a nurse-led intervention promoting the maintenance of lifestyle modification
  • Другое Brief advice
    once-off brief lifestyle advice lasting for 15 minutes

Первичные конечные точки

  • Metabolic syndrome reversal [Срок оценки: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks]
Вторичные конечные точки (4)
  • Health-promoting behaviours [Срок оценки: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks]
  • Metabolic syndrome components [Срок оценки: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks]
  • Health-related quality of life [Срок оценки: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks]
  • Blood lipid measures [Срок оценки: At baseline (T0), immediately at the end of the active intervention phase (12 weeks after baseline)(T1), and 8 weeks thereafter (20 weeks after baseline) (T2).]

Критерии участия

Критерии включения

  • Chinese adults with metabolic syndrome defined by the 'Harmonising the metabolic syndrome' (HMS) criteria by three or more abnormal findings out of five defining characteristics (i.e., raised blood pressure, raised triglycerides, lowered high-density lipoprotein, raised fasting blood glucose, and central obesity)
  • aged ≥18
  • community-dwelling
  • independent in daily living
  • possessed a digital device with an internet connection

Критерии исключения

  • Has established atherosclerotic cardiovascular diseases (coronary heart disease, cerebrovascular disease and peripheral arterial disease)
  • Has psychiatric diseases
  • Cannot read Chinese
  • Has impaired communication or cognitive function (as indicated by an Abbreviated Mental Test Score of ≤6)

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Гонконг · 1 центр
  • Local community centres — Гонконг

Идентификаторы

NCT: NCT06793930 · UW 24-306 · HKUCTR-3030

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗