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Идёт набор NCT05630508

Lifestyle Management App for Adults With Diabetes Type

Без фазы С лечением Diabetes Mellitus, Type 2

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: interactive Mhealth Lifestyle behavior intervention, Sham.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 2. 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
Саудовская Аравия
Следующий шаг
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Официальное название

mHealth Lifestyle Management Program (LIVEN) For Adults With Diabetes Type 2: A Feasibility Study

Обзор

This study will evaluate whether the 12-week health coaching mobile application (LIVEN) will succeed in enhancing lifestyle behaviors in adults with Type 2 Diabetes compared to typical treatment. The mobile application's viability will be assessed in 2 parts; the first part is testing easiness and friendliness of using Liven by the patient and health coach. The second part is evaluating the suitability of Liven education material for the patients and whether the coaching program results in enhancing lifestyle behaviors and blood sugar levels. the investigators hypothesize that the 12-week online lifestyle-coaching program will be viable, and a full-scale study can proceed.

Подробное описание

This study will investigate the feasibility of a 12-weeks online lifestyle (nutrition and physical behavior) coaching program through a mobile app (LIVEN) compared to standard treatment for people with type 2 diabetes. This study will be done in two phases; the first phase is the usability study (phase1), in which the user friendliness of the application will be assessed, and any technical flaws will be resolved prior and during the second phase. The second phase of the study will consist of adapting a diabetes educational material and assessing the feasibility of the program (phase2). the investigators hypothesize that the 12-week online lifestyle-coaching program will be feasible, and a full-scale study can proceed.

Вмешательства

  • Поведенческое interactive Mhealth Lifestyle behavior intervention
    Receiving Standard care, LIVEN educational material and interactive LIVEN application, via having a human component which is a health coach for 3 months
  • Другое Sham
    Receiving standard care, LIVEN educational material and access to the application

Первичные конечные точки

  • recruitment rate - descriptive [Срок оценки: immediately after the intervention (3 months)]
  • retention rates [Срок оценки: immediately after the intervention (3 months)]
  • User friendliness [Срок оценки: Daily application engagement data for each patient will be analyzed once at the end of the patient's 12 week program.]
Вторичные конечные точки (7)
  • Glycemic control - A1c [Срок оценки: will be assessed one week prior to the intervention and one week after the end of the intervention]
  • Glycemic control - continuous glucose mentoring (CGM) [Срок оценки: will be assessed one week prior to the intervention and one week after the end of the intervention]
  • Body composition - fat free mass (%) physiological parameter [Срок оценки: will be assessed one week prior to the intervention and one week after the end of the intervention]
  • Lifestyle behaviors - Health-Promoting Lifestyle profile II (Questionnaire) [Срок оценки: will be assessed one week prior to the intervention and one week after the end of the intervention]
  • physical performance assessments - upper body muscle strength in kg [Срок оценки: will be assessed one week prior to the intervention and one week after the end of the intervention]
  • physical performance assessments - lower body muscle strength in counts [Срок оценки: will be assessed one week prior to the intervention and one week after the end of the intervention]
  • physical performance assessments - endurance [Срок оценки: will be assessed one week prior to the intervention and one week after the end of the intervention]

Критерии участия

Критерии включения

  • Adults, aged 18 years or older
  • Arabic speakers
  • Capable of utilizing smartphones
  • Diagnosed with T2DM
  • Poor glycemic control: A1c > 7.5%

Критерии исключения

  • Individuals using insulin injection
  • Individuals suffering from disorders that might affect intervention (e.g. amputation, enucleation of the eye, or end-stage kidney disease)
  • Women who are pregnant or breastfeeding
  • Individuals diagnosed with other types of diabetes (such as type I or MODY)

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
Поддерживающая терапия

Центры проведения

Саудовская Аравия · 1 центр
  • Princess Nourah bint Abdulrahman University — Riyadh

Идентификаторы

NCT: NCT05630508 · 22-0140

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗