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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05892861
Other study ID # 21-065-B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2021
Est. completion date March 31, 2023

Study information

Verified date June 2023
Source National Kaohsiung Normal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
cognitive stimulation
video education, board games, and 24-hour dietary recall record
Other:
as usual care
history taking, explain data, and discuss how to control healthy condition

Locations

Country Name City State
Taiwan Yong-Kang Clinic Kaohsiung

Sponsors (2)

Lead Sponsor Collaborator
National Kaohsiung Normal University National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Primary 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 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
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