Clinical trial NCT05892861: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes Mellitus
Cognitive Impairment, Mild
Lead sponsor: National Kaohsiung Normal University
Sponsor class: OTHER
Collaborators: name: National Cheng-Kung University Hospital
First posted: 2023-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change of cognitive function from baseline at 3 and 6 months
timeFrame: 12th week & 24 week
Secondary outcomes:
measure: The change of dietary control belief from baseline at 3 and 6 months
timeFrame: 12th week and 24th week
Other outcomes:
measure: The change of the awareness of complication and health behavior from baseline at 3 and 6 months
timeFrame: 12th week and 24th week
measure: The change of HbA1C from baseline at 3 and 6 months
timeFrame: 12th week and 24th week
measure: The change of total cholesterol from baseline at 3 and 6 months
timeFrame: 12th week and 24th week
measure: The change of triglyceride from baseline at 3 and 6 months
timeFrame: 12th week and 24th week
measure: The change of low-density lipoprotein cholesterol from baseline at 3 and 6 months
timeFrame: 12th week and 24th week
measure: The change of high-density lipoprotein cholesterol from baseline at 3 and 6 months
timeFrame: 12th week and 24th week
measure: The change of health behavior awareness from baseline at 3 and 6 months
timeFrame: 12th week and 24th week
measure: The change of health behavior frequency per week from baseline at 3 and 6 months
timeFrame: 12th week and 24th week
Locations:
city: Kaohsiung
country: Taiwan
facility: Yong-Kang Clinic
Study officials:
affiliation: National Kaohsiung Normal University
name: Ling-Chun Ou
role: PRINCIPAL_INVESTIGATOR
References: