The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

NCT05892861 | Completed

• 1 other identifier: 21-065-B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes Mellitus; Cognitive Impairment, Mild

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  12th week and 24th week

Other Outcomes (8)

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

  12th week and 24th week

• The change of HbA1C from baseline at 3 and 6 months

  12th week and 24th week

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

  12th week and 24th week

Study Arms (2)

multi domain dietary education as cognitive stimulation

EXPERIMENTAL

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

Behavioral: cognitive stimulation

usual clinical treatment

EXPERIMENTAL

usual treatment in clinic

Other: as usual care

Interventions

cognitive stimulation BEHAVIORAL

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

multi domain dietary education as cognitive stimulation

as usual care OTHER

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

usual clinical treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Kaohsiung Normal University: lead
• National Cheng-Kung University Hospital: collaborator

Study Sites (1)

Yong-Kang Clinic

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ling-Chun Ou

  National Kaohsiung Normal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: June 7, 2023
• Study Start: June 3, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: March 11, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)