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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Comparison of dietary adherence at 3-month and 6-month between the usual care group and intervention group
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Comparison of dietary adherence at 3-month and 6-month between the usual care group and intervention group
时间窗: Baseline, 3-month, and 6-month
Dietary adherence to diabetic diet will be evaluated against a modified healthy eating index (HEI). A 3-day dietary record methodology (2 weekdays and 1 weekend) will be used and analyzed based on Malaysian and Singapore Food Composition Databases. The modified version of HEI used in this study consists of 14 components. Sum scores of each component yields and overall score of diet quality which will be converted into scale of zero to 100. A higher the HEI score indicates a greater adherence. The overall dietary adherence will be classified as low (below 51%), needing improvement (51-80%), or high (more than 80 points)
次要结局
- Comparison of glycated hemoglobin (HbA1c) at 3-month and 6-month between the usual care group and intervention group(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(Baseline, 3-month, and 6-month)
研究者
ESTHER ALIM ALBERT
REGISTERED DIETITIAN
Universiti Malaysia Sabah