Effectiveness of Text Messaging Intervention to Improve Dietary Behaviors Among Patients with Type 2 Diabetes Mellitus in Low Resource Area of Sabah (DTEXT-SBH)
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: Control Group, Intervention Group.
- Кому может быть актуально
- Состояния в реестре: Type 2 Diabetes Mellitus(T2DM). Базовые параметры: 18 лет — 60 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
- Малайзия
- 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
Effectiveness of Text Messaging Intervention to Improve Dietary Behaviors Among Patients with Type 2 Diabetes Mellitus in Low Resource Area of Sabah: a Randomized, Open-Label, Controlled Trial
Обзор
The goal of this clinical trial is to learn if sending three (3) text messages per week over a six (6) months period to people with Type 2 Diabetes in areas with lack access to dietitian could help them stick to a healthier diet. The main questions it aims to answer are: * Does a mobile phone text-message intervention improve dietary adherence among T2DM patients? * Does a mobile phone text-message intervention improve HbA1c and self-management among T2DM patients? Researchers will compare dietary adherence, HbA1c changes and self-management behaviors between the usual care group and intervention group. Participants will: * Be given three (3) text messages per week over a six (6) months period for the intervention group * Both usual care and intervention group will be given standard medical nutrition therapy at baseline, 3rd and 6th months visits to the clinic
Вмешательства
- Другое Control Group
Participants from the intervention group will receive the usual care over the 6-month intervention period - Другое Intervention Group
Participants from the intervention group will receive the usual care and an additional three text messages per week via WhatsApp over the 6-month intervention period
Первичные конечные точки
- Comparison of dietary adherence at 3-month and 6-month between the usual care group and intervention group [Срок оценки: Baseline, 3-month, and 6-month]
Вторичные конечные точки (2)
- Comparison of glycated hemoglobin (HbA1c) at 3-month and 6-month between the usual care group and intervention group [Срок оценки: Baseline, 3-month, and 6-month]
- Comparison of self-management behavior at 3-month and 6-month between the usual care group and intervention group [Срок оценки: Baseline, 3-month, and 6-month]
Критерии участия
Критерии включения
- have type 2 diabetes.
- own a mobile phone.
- able to use WhatsApp.
- able to read and speak Bahasa Malaysia.
- have an HbA1c level above 7.0%.
- have not seen a dietitian in the previous 6 months.
Критерии исключения
- individuals with type 1 diabetes mellitus and gestational diabetes mellitus.
- patients with cognitive impairment affecting memory, attention, language, and problem-solving skills.
- those with advanced diabetic complications, such as kidney failure and neuropathy.
- individuals lacking regular access to a mobile phone or with poor network connectivity.
- pregnant individuals or those planning to get pregnant in the next 6 months, as well as those currently nursing.
- individuals with major illnesses like cancer or advanced heart disease.
- those planning major surgery or gastric bypass in the next 6 months.
- institutionalized individuals, such as those in nursing homes, old folks\' homes, or imprisoned.
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
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
Малайзия · 1 центр
- Ranau District Hospital and Klinik Kesihatan Kundasang — Kota Kinabalu
Публикации
- Arora S, Peters AL, Burner E, Lam CN, Menchine M. Trial to examine text message-based mHealth in emergency department patients with diabetes (TExT-MED): a randomized controlled trial. Ann Emerg Med. 2014 Jun;63(6):745-54.e6. doi: 10.1016/j.annemergmed.2013.10.012. Epub 2013 Nov 11. PMID 24225332
- Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016 PMID 24622367
Идентификаторы
NCT: NCT06587581 · RSCH ID-24-01119-NHX