The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

Conditions
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Type2 Diabetes Mellitus, Cognitive Impairment, Mild

Intervention / Treatment
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* Behavioral: cognitive stimulation
* Other: as usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multi domain dietary education as cognitive stimulation<br>video lifestyle education, board game, and 24-hour dietary recall record from 1st week to 10th week as cognitive stimulation. | Behavioral: cognitive stimulation<br>* video education, board games, and 24-hour dietary recall record<br>|
| Experimental: usual clinical treatment<br>usual treatment in clinic | Other: as usual care<br>* history taking, explain data, and discuss how to control healthy condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |