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The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

Primary Purpose

Type2 Diabetes Mellitus, Cognitive Impairment, Mild

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cognitive stimulation
as usual care
Sponsored by
National Kaohsiung Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes Mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yong-Kang Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

multi domain dietary education as cognitive stimulation

usual clinical treatment

Arm Description

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

usual treatment in clinic

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2023
Last Updated
June 8, 2023
Sponsor
National Kaohsiung Normal University
Collaborators
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05892861
Brief Title
The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults
Official Title
The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Kaohsiung Normal University
Collaborators
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus, Cognitive Impairment, Mild

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
multi domain dietary education as cognitive stimulation
Arm Type
Experimental
Arm Description
video lifestyle education, board game, and 24-hour dietary recall record from 1st week to 10th week as cognitive stimulation.
Arm Title
usual clinical treatment
Arm Type
Experimental
Arm Description
usual treatment in clinic
Intervention Type
Behavioral
Intervention Name(s)
cognitive stimulation
Intervention Description
video education, board games, and 24-hour dietary recall record
Intervention Type
Other
Intervention Name(s)
as usual care
Intervention Description
history taking, explain data, and discuss how to control healthy condition
Primary Outcome Measure Information:
Title
The change of cognitive function from baseline at 3 and 6 months
Description
Saint Louis University Mental State examination, the total score range is 0~30. Higher scores mean better change.
Time Frame
12th week & 24 week
Secondary Outcome Measure Information:
Title
The change of dietary control belief from baseline at 3 and 6 months
Description
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.
Time Frame
12th week and 24th week
Other Pre-specified Outcome Measures:
Title
The change of the awareness of complication and health behavior from baseline at 3 and 6 months
Description
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.
Time Frame
12th week and 24th week
Title
The change of HbA1C from baseline at 3 and 6 months
Description
biomedical data after phlebotomy (HbA1C in %), Higher scores mean worse change.
Time Frame
12th week and 24th week
Title
The change of total cholesterol from baseline at 3 and 6 months
Description
biomedical data after phlebotomy (total cholesterol in mg/dl). Higher scores mean worse change.
Time Frame
12th week and 24th week
Title
The change of triglyceride from baseline at 3 and 6 months
Description
biomedical data after phlebotomy (triglyceride in mg/dl). Higher scores mean worse change.
Time Frame
12th week and 24th week
Title
The change of low-density lipoprotein cholesterol from baseline at 3 and 6 months
Description
biomedical data after phlebotomy (low-density lipoprotein cholesterol in mg/dl). Higher scores mean worse change.
Time Frame
12th week and 24th week
Title
The change of high-density lipoprotein cholesterol from baseline at 3 and 6 months
Description
biomedical data after phlebotomy (high-density lipoprotein cholesterol in mg/dl). Higher scores mean worse change.
Time Frame
12th week and 24th week
Title
The change of health behavior awareness from baseline at 3 and 6 months
Description
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.
Time Frame
12th week and 24th week
Title
The change of health behavior frequency per week from baseline at 3 and 6 months
Description
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.
Time Frame
12th week and 24th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling-Chun Ou
Organizational Affiliation
National Kaohsiung Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yong-Kang Clinic
City
Kaohsiung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults

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