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Идёт набор NCT06752772

WeArable teChnology daTa driVen digitAl healTh cOachINg (ACTIVATION)- A Mixed-methods Study

Без фазы С лечением Elevated Blood Pressure Hypertension Overweight/Obesity Type 2 Diabetes Mellitus (T2DM)

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: Smart watch, Dashboard with nudging system, Digital Health Coach (DHC).
Кому может быть актуально
Состояния в реестре: Elevated Blood Pressure, Hypertension, Overweight/Obesity, Type 2 Diabetes Mellitus (T2DM). Базовые параметры: 21 лет — 75 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
Сингапур
Следующий шаг
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Обзор

Public health priorities have shifted towards disease prevention, emphasising health promotion and lifestyle interventions to reduce disease burden. Despite global efforts, the prevalence of chronic diseases remains high, with lifestyle factors such as alcohol consumption, diet, smoking, obesity, and sedentary behaviour playing significant roles. In Singapore, suboptimal lifestyle behaviours are common, contributing to a high incidence of chronic conditions. Metabolic syndrome (MetS), linked to obesity, poses a growing societal burden due to its association with cardiovascular risks. Disparities exist in the delivery of lifestyle interventions among healthcare providers (HCPs), with many patients receiving inadequate guidance. Digital health coaching, incorporating wearable technology, offers promising solutions to bridge these gaps, providing personalised, real-time support and feedback to improve lifestyle behaviours and prevent disease progression. Challenges such as time constraints, lack of feedback, and limited support can be addressed through remote monitoring and tailored interventions, making scalable population-level interventions feasible.

Вмешательства

  • Устройство Smart watch
    Participants are required to wear the study issued smart watch for at least 8 hours a day during the intervention period and are encouraged to wear it beyond the study intervention period.
  • Поведенческое Dashboard with nudging system
    Nudges will be sent to participants' smart watch/mobile application with messages that are designed to motivate them to lead a healthy lifestyle.
  • Устройство Digital Health Coach (DHC)
    Participants will be assigned to a DHC and the DHC will be providing them with remote health coaching assistance for a duration of 6 months, upon successful enrolment.

Первичные конечные точки

  • Changes in physical activity level [Срок оценки: Baseline, 6- and 12-month post study enrolment]
Вторичные конечные точки (8)
  • Engagement and sustainability [Срок оценки: Baseline, 3- , 6-, 9-, and 12-month post study enrolment]
  • Acceptability of the study [Срок оценки: 6-, 9- and 12-month post study enrolment]
  • Satisfaction towards the intervention provided [Срок оценки: 6-month post study enrolment]
  • Lifestyle changes (Diet) [Срок оценки: Baseline, 6-, and 12-month post enrolment]
  • Lifestyle changes (Smoking Cessation) [Срок оценки: Baseline, 6-, and 12-month post enrolment]
  • Lifestyle changes (Alcohol Cessation) [Срок оценки: Baseline, 6-, and 12-month post enrolment]
  • Self-efficacy [Срок оценки: Baseline, 6-, and 12-month post enrolment]
  • Quality of Life [Срок оценки: Baseline, 6-, and 12-month post enrolment]

Критерии участия

Критерии включения

  • 21-75 years old
  • Patients who are at risk of any of the following:
  • Elevated blood pressure
  • Overweight (BMI>=23kg/m2)
  • Pre-diabetes, OR
  • Patients who have one or more of the following (HOLD) conditions:
  • Hypertension
  • Obesity (BMI>=27.5kg/m2)
  • HyperLipidemia
  • Type 2 Diabetes Mellitus
  • Patients who own a smartphone
  • Patients who are willing to wear a smartwatch during the intervention period.

Критерии исключения

  • Patients who have a medical condition that prevented participation in physical activity
  • Patients who have current diagnosis or history of eating disorder, depression
  • Patients who are currently pregnant or planning to become pregnant in the next 6 months
  • Patients who are currently participating in a weight loss programme (commercial, medically supervised, or research study)
  • Patients who are on weight loss medications (over-the-counter or prescription)
  • Patients who are not mentally-, physically- or technologically-capable
  • Patients who is unable to provide informed consent.

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
Другое

Центры проведения

Сингапур · 1 центр
  • Alexandra Hospital — Singapore

Идентификаторы

NCT: NCT06752772 · DSRB2023/00276

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗