The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

Not Applicable

Completed

• Conditions: Cognitive Impairment, Mild; Type2 Diabetes Mellitus
• Interventions: Behavioral: cognitive stimulation; Other: as usual care

• Registration Number: NCT05892861
• Lead Sponsor: National Kaohsiung Normal University

Brief 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.

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 Timeline

• Study Start: 2021-06-03
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31
• Study First Submitted: 2023-05-14
• Study First Submitted QC: 2023-05-28
• Status Verified: 2023-06
• Study First Posted: 2023-06-07
• Last Update Submitted: 2025-03-08
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
multi domain dietary education as cognitive stimulation	cognitive stimulation	video lifestyle education, board game, and 24-hour dietary recall record from 1st week to 10th week as cognitive stimulation.
usual clinical treatment	as usual care	usual treatment in clinic

Primary Outcome Measures

Name	Time	Method
The change of cognitive function from baseline at 3 and 6 months	12th week & 24 week	Saint Louis University Mental State examination, the total score range is 0\~30. Higher scores mean better change.

Secondary Outcome Measures

Name	Time	Method
The change of dietary control belief from baseline at 3 and 6 months	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.

Trial Locations

Locations (1)

Yong-Kang Clinic; 🇨🇳 Kaohsiung, Taiwan