The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

Type2 Diabetes Mellitus Clinical Trial

Official title:

The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892861
• Other study ID #: 21-065-B
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

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