The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes Mellitus; Cognitive Impairment, Mild
• Intervention / Treatment: Behavioral: cognitive stimulation; Other: as usual care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Yong-Kang Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: National Kaohsiung Normal University
• Collaborators: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: Ling-Chun Ou, National Kaohsiung Normal University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: May 28, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 8, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Glucose Metabolism Disorders; Diabetes Mellitus; Cognition Disorders; Cognitive Dysfunction; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 21-065-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No