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| Name | Class |
|---|---|
| National Cheng-Kung University Hospital | OTHER |
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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.](streamdown:incomplete-link)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multi domain dietary education as cognitive stimulation | Experimental | video lifestyle education, board game, and 24-hour dietary recall record from 1st week to 10th week as cognitive stimulation. |
|
| usual clinical treatment | Experimental | usual treatment in clinic |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive stimulation | Behavioral | video education, board games, and 24-hour dietary recall record |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of cognitive function from baseline at 3 and 6 months | Saint Louis University Mental State examination, the total score range is 0~30. Higher scores mean better change. | 12th week & 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| The change of dietary control belief from baseline at 3 and 6 months | 12 questions by Linkert scale (4 questions about dietary mastery items and 8 questions about dietary perceived constraints items) about dietary control belief(the total score range is 12 to 60) Higher scores mean better change. | 12th week and 24th week |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the awareness of complication and health behavior from baseline at 3 and 6 months | 8 questions about the complications of type 2 DM (stroke, blind, wood healing, amputation, CKD, CAD, hypoglycemia, and Dementia) by Linkert scale (the total score range is 8 to 40). Higher scores mean better change. | 12th week and 24th week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ling-Chun Ou | National Kaohsiung Normal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yong-Kang Clinic | Kaohsiung City | Taiwan |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| as usual care | Other | history taking, explain data, and discuss how to control healthy condition |
|
| The change of HbA1C from baseline at 3 and 6 months |
biomedical data after phlebotomy (HbA1C in %), Higher scores mean worse change. |
| 12th week and 24th week |
| The change of total cholesterol from baseline at 3 and 6 months | biomedical data after phlebotomy (total cholesterol in mg/dl). Higher scores mean worse change. | 12th week and 24th week |
| The change of triglyceride from baseline at 3 and 6 months | biomedical data after phlebotomy (triglyceride in mg/dl). Higher scores mean worse change. | 12th week and 24th week |
| The change of low-density lipoprotein cholesterol from baseline at 3 and 6 months | biomedical data after phlebotomy (low-density lipoprotein cholesterol in mg/dl). Higher scores mean worse change. | 12th week and 24th week |
| The change of high-density lipoprotein cholesterol from baseline at 3 and 6 months | biomedical data after phlebotomy (high-density lipoprotein cholesterol in mg/dl). Higher scores mean worse change. | 12th week and 24th week |
| The change of health behavior awareness from baseline at 3 and 6 months | 9 questions about health behavior (body weight measurement, foot care, blood pressure measurement, drug adherence, diet adherence, calculation of intake amount by hand when eating, smoking habits, drinking habits, and exercise habits) by Linkert scale (total score range is 9 to 45). Higher scores mean better change. | 12th week and 24th week |
| The change of health behavior frequency per week from baseline at 3 and 6 months | 9 questions about health behavior (body weight measurement, foot care, blood pressure measurement, drug adherence, diet adherence, calculation of intake amount by hand when eating, smoking habits, drinking habits, and exercise habits) by Linkert scale (total score range is 9 to 45). Higher scores mean better change. | 12th week and 24th week |