The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change of cognitive function from baseline at 3 and 6 months
研究概览
简要总结
The goal of this clinical trial is to [learn about cognitive stimulation by multidomain dietary education including the dietary board game via LINE in non-dementic type 2 diabetic adults. The main questions it aims to answer are:
[Question 1: Could multi-domain dietary education as cognitive stimulation improve cognitive function?] [Question 2: Could multi-domain dietary education improve dietary control belief ?] [Question 3: Could multi-domain dietary education improve health behavior?] [Question 4]: Could multi-domain dietary education improve HbA1C, and lipid profile? Participants of experimental A group will receive a video about lifestyle education 5 minutes weekly for 3 weeks, a dietary board game 10 minutes weekly for 10 weeks, and a 24-hour dietary recall record 2 times weekly for 7 weeks. And participants of the experimental B group receive the usual clinical treatment. Then experimental A and Experimental B groups will cross over 12 weeks later.
Researchers will compare the effect of intervention between the experimental A group and the experimental B group.
详细描述
Cognitive function was measured by the Saint Louis University Mental State (SLUMS) score. And we exclude the dementia group according to the SLUMS definition (<21 if the participants graduated from senior high school or above, <20 if the education level below senior high school).
Experimental group A received 10-week curriculum from 1st week to 10th week, and receive d usual clinical care from 13th week to 22th week. Experimental B group received usual clinical care from 1st week to 10th week, and received 10-week curriculum from 13th week to 22th week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The onset age of Diabetes Mellitus is more than 20 years old
- •Diagnosis of Diabetes according to past history including type 2 diabetes mellitus or drug history including oral anti-diabetic drugs
排除标准
- •SLUMS meets the Dementia definition.
- •HbA1C ≥ 10.0%
- •Rejected our study.
- •History of stroke.
- •History of depression.
- •History of psychiatric disease.
- •Visual impairment.
- •Hearing impairment.
- •Can't understand the informed consent
结局指标
主要结局
The change of cognitive function from baseline at 3 and 6 months
时间窗: 12th week & 24 week
Saint Louis University Mental State examination, the total score range is 0\~30. Higher scores mean better change.
次要结局
- The change of dietary control belief from baseline at 3 and 6 months(12th week and 24th week)
研究者
Ou Ling-Chun
Principal Investigator
National Kaohsiung Normal University