Type2 Diabetes MellitusNCT05892861
The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults
A study testing cognitive stimulation in people with Type2 Diabetes Mellitus and Cognitive Impairment, Mild, run by National Kaohsiung Normal University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type2 Diabetes Mellitus, Cognitive Impairment, Mild
- What is being tested?
- cognitive stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jun 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- SLUMS meets the Dementia definition.
- HbA1C ≥ 10.0%
- Rejected our study.
- History of stroke.
- History of depression.
- History of psychiatric disease.
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- Visual impairment.
- Hearing impairment.
- Can't understand the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- cognitive stimulation, as usual care
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive stimulationBehavioural
video education, board games, and 24-hour dietary recall record
as usual careOther
history taking, explain data, and discuss how to control healthy condition
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: cognitive stimulation |
| usual clinical treatment | Experimental | usual treatment in clinic Receives: Other: as usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12th week & 24 week
Secondary outcomes (1)
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.
Measured: 12th week and 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start3 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Kaohsiung Normal University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Responsible party
- Principal investigator, Ou Ling-Chun, National Kaohsiung Normal University
- Investigators
- Ling-Chun Ou, Principal investigator, National Kaohsiung Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892861
- Sponsor's protocol ID
- 21-065-B
- Status last verified
- Jun 2023
- First submitted
- 14 May 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults
- ClinicalTrials.gov ID
- NCT05892861
- Acronym / sponsor ID
- 21-065-B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Kaohsiung Normal UniversityUniversity, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multi domain dietary education as cognitive stimulation | Experimental | Behavioral: cognitive stimulationvideo lifestyle education, board game, and 24-hour dietary recall record from 1st week to 10th week as cognitive stimulation. |
| usual clinical treatment | Experimental | Other: as usual careusual treatment in clinic |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- SLUMS meets the Dementia definition.
- HbA1C ≥ 10.0%
- Rejected our study.
- History of stroke.
- History of depression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive stimulationvideo education, board games, and 24-hour dietary recall record | Behavioural | multi domain dietary education as cognitive stimulation |
| as usual carehistory taking, explain data, and discuss how to control healthy condition | Other | usual clinical treatment |
Primary outcome
The change of cognitive function from baseline at 3 and 6 months
Time frame: 12th week & 24 week
Saint Louis University Mental State examination, the total score range is 0~30. Higher scores mean better change.
1 secondary outcome
The change of dietary control belief from baseline at 3 and 6 months
Time frame: 12th week and 24th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling-Chun Ou principal investigator
National Kaohsiung Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive stimulation in people with Type2 Diabetes Mellitus and Cognitive Impairment, Mild, run by National Kaohsiung Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of cognitive function from baseline at 3 and 6 months (time frame: 12th week & 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.