The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

NCT ID: NCT05892861

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-03

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Type2 Diabetes Mellitus Cognitive Impairment, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

cognitive stimulation

Intervention Type BEHAVIORAL

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

usual clinical treatment

usual treatment in clinic

Group Type EXPERIMENTAL

as usual care

Intervention Type OTHER

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

Interventions

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cognitive stimulation

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

Intervention Type BEHAVIORAL

as usual care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

National Kaohsiung Normal University

OTHER

Sponsor Role lead

Responsible Party

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Ou Ling-Chun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ling-Chun Ou

Role: PRINCIPAL_INVESTIGATOR

National Kaohsiung Normal University

Locations

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Yong-Kang Clinic

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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21-065-B

Identifier Type: -

Identifier Source: org_study_id

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