The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

National Kaohsiung Normal University

Status: Completed

Conditions: Type2 Diabetes Mellitus; Cognitive Impairment, Mild

Treatments: Behavioral: cognitive stimulation; Other: as usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05892861

21-065-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

multi domain dietary education as cognitive stimulation

Experimental group

Description:

video lifestyle education, board game, and 24-hour dietary recall record from 1st week to 10th week as cognitive stimulation.

Treatment:

Behavioral: cognitive stimulation

usual clinical treatment

Experimental group

Description:

usual treatment in clinic

Treatment:

Other: as usual care