Skip to main content
OpenTrials
Completed

NCT Number: NCT05892861

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type2 Diabetes Mellitus Cognition Disorders Cognitive Dysfunction Cognitive Impairment, Mild Mental Disorders Neurocognitive Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yong-Kang Clinic

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive stimulation

Behavioral

video education, board games, and 24-hour dietary recall record

as usual care

Other

history taking, explain data, and discuss how to control healthy condition

Primary outcomes

  1. The change of cognitive function from baseline at 3 and 6 months

    Time frame: 12th week & 24 week

    Saint Louis University Mental State examination, the total score range is 0~30. Higher scores mean better change.

Secondary outcomes

  1. The change of dietary control belief from baseline at 3 and 6 months

    Time frame: 12th week and 24th week

    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.

Other outcomes

  1. The change of the awareness of complication and health behavior from baseline at 3 and 6 months

    Time frame: 12th week and 24th week

    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.

  2. The change of HbA1C from baseline at 3 and 6 months

    Time frame: 12th week and 24th week

    biomedical data after phlebotomy (HbA1C in %), Higher scores mean worse change.

  3. The change of total cholesterol from baseline at 3 and 6 months

    Time frame: 12th week and 24th week

    biomedical data after phlebotomy (total cholesterol in mg/dl). Higher scores mean worse change.

  4. The change of triglyceride from baseline at 3 and 6 months

    Time frame: 12th week and 24th week

    biomedical data after phlebotomy (triglyceride in mg/dl). Higher scores mean worse change.

  5. The change of low-density lipoprotein cholesterol from baseline at 3 and 6 months

    Time frame: 12th week and 24th week

    biomedical data after phlebotomy (low-density lipoprotein cholesterol in mg/dl). Higher scores mean worse change.

  6. The change of high-density lipoprotein cholesterol from baseline at 3 and 6 months

    Time frame: 12th week and 24th week

    biomedical data after phlebotomy (high-density lipoprotein cholesterol in mg/dl). Higher scores mean worse change.

  7. The change of health behavior awareness from baseline at 3 and 6 months

    Time frame: 12th week and 24th week

    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.

  8. The change of health behavior frequency per week from baseline at 3 and 6 months

    Time frame: 12th week and 24th week

    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.

Sponsors and collaborators

Lead sponsor

National Kaohsiung Normal University

Other

Collaborators

  • National Cheng-Kung University Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2023
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.