Develop the Mini-flipped Game-based Learning Strategies in Modified Mediterranean Diet Interventions for Eating Behavior and Cognitive Performance Among Older Adults in the Community
Phase: NA
Conditions: Healthy
Sponsor: National Yang Ming Chiao Tung University

 
 
 
 
 
Official Title: Develop the Mini-flipped Game-based Learning 
Strategies in Modified Mediterranean Diet Interventions for 
Eating Behavior and Cognitive Performance Among Older 
Adults in the Community 
NCT number: NCT04788446 
Document date: July 6th, 2021 
 

Study Protocol 
Background 
The world is facing an aging population and the number of people with mild 
cognitive impairment and dementia is increasing, causing a huge burden of medical 
costs for individuals, families and society. Previous studies have shown that the 
Mediterranean Diet (MD) can prevent cognitive decline, but older adults are less likely 
to follow the Mediterranean Diet and have little knowledge about the risk of dementia 
and protective factors of the diet. The Game-based learning can enhance the learning 
effectiveness and motivation of the elderly. In this study, the content of the Asian 
version of the Mediterranean Diet Pyramid and the local food materials from Taiwan 
will be integrated into the nutritional health education with game strategies of the 
Modified Mediterranean diet. 
Objective 
The purpose of this study was to explore the effect of developing Mini-flipped 
Game-based learning Strategies in Modified Mediterranean diet learning intervention 
to promote eating behavior and cognitive function of elderly people in community.  
Methods 
1. Study design:  
This study was designed as a cluster randomized controlled trial. First, six 
communities were selected from Taipei Beitou District, and then randomly assigned to 
the experimental group and the control group by computer. A total of 80 elderly people 
were included in this study. The inclusion conditions of the research subjects include: 
(1) the elderly over 65 years old; (2) Those who have no visual or hearing impairment 
or mental impairment and can communicate in Chinese and Taiwanese; (3) Those who 
are willing to participate in the research and fill in the voluntary consent form. 
Exclusion criteria were :(1) diagnosed with cognitive dysfunction, brain injury and loss 

of consciousness for more than 30 minutes or other central nervous system diseases; (2) 
Suffering from serious diseases, such as organ failure of heart, liver and lung, end-stage 
kidney disease, general paralysis, end-stage cancer or chemotherapy, and diagnosis of 
mental diseases. 
2. Research tools:  
The measurements included a demographic information, the Mediterranean Diet 
score, the Chinese version of the Montreal Cognitive Assessment Scale, the Chinese 
version of the Cognitive Failures Questionnaire, the Nutrition Knowledge for the 
Elderly Scale, the Chinese version Pittsburgh Sleep Quality Index, and the Center for 
Epidemiological Studies Depression Scale. The study was a single-blind design and 
was measured at the pre-test (week 0) and post-test (week 8). 
3. Intervention approaches: 
The experimental group used a Mini-flipped game-based learning strategies in 
modified Mediterranean diet learning intervention, and the duration of the intervention 
was 8 weeks, with 40-minute Mini-flipped game-based learning strategies in modified 
Mediterranean diet learning each week, which the content included: the relationship 
between the Mediterranean diet and dementia, knowledge of the Mediterranean diet, 
and how to incorporate local ingredients into the Mediterranean diet. The control group 
was given a leaflet on balanced diet and nutrition in elderly by the Health Promotion 
Administration. 

  
Statistical Analysis Plan 
SPSS25 software was used for data analysis. The scores of socio demography, 
eating behavior, cognitive function, nutritional knowledge, depression and sleep in the 
two groups were described by the descriptive statistical methods, such as percentage, 
mean and standard difference. Chi-square test (χ2 test), Fisher's exact test or 
independent t-test were used to test the homogeneity of the two groups of data. In this 
study, generalized estimating equations (GEE) were used to measure the differences in 
dietary behavior, cognitive function and nutritional knowledge between the two groups 
before and after intervention. Two-tail test was used for all statistical analyses, and the 
significance level α=0.05 was set.