Clinical trial NCT04788446: Mediterranean Diet Interventions for Eating Behavior and Cognitive Performance Among Older Adults in the Community
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Mini-flipped Game-based Learning
Mediterranean Diet
Eating Behavior
Cognitive Performance
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The object is to investigate the effects of a modified Mediterranean diet learning intervention program with a Mini-flipped game strategy on dietary behavior and cognitive function of elderly people in the community. The six communities were randomly assigned to the experimental group and the control group. The intervention group will last for 8 weeks. An eight-week Mediterranean diet learning program applying mini-flipped game-based learning strategies could improve dietary behavior and global cognitive function among elderly people living in the general community.

Detailed description: Background：The world is facing an aging population, with an increase in the number of people with mild cognitive impairment and dementia, creating a huge burden of medical costs for individuals, families, and society. Previous studies have shown that the Mediterranean Diet delays cognitive decline, but older adults are less likely to follow the Mediterranean Diet and have less knowledge about the risk of dementia and protective factors of the diet. This study will integrate the Asian version of the Mediterranean Diet Pyramid and local ingredients from Taiwan to design a nutritional health education and game intervention for the Mediterranean Diet.

Purposes：To investigate the effectiveness of developing a Mini-flipped Game-based Learning strategy to promote dietary behavior and cognitive function in the community elderly with a modified diet learning intervention.

Methods：This study was a cluster-randomized controlled trial. The six communities were randomly assigned to the experimental group and the control group.The intervention group completed an eight-week, mini-flipped, game-based learning program reinforcing compliance with the Mediterranean diet, consisting of one 40-minute session per week. The control group members maintained their usual daily diet and were given a booklet on nutrition and health. All participants will be assessed at baseline(0 weeks) and post-test(8 weeks).

Eligibility criteria: Inclusion Criteria:

* Age 65 years and older
* No visual, hearing, or mental impairment, and could speak Mandarin.
* Are willing to participate in the study and fill out the volunteer consent form.

Exclusion Criteria:

* Diagnosis of cognitive dysfunction, brain injury with loss of consciousness for more than 30 minutes, or other central nervous system disorders. The presence of impaired sensory problems.
* Severe illnesses such as heart, liver, and lung failure, end-stage renal disease, total paralysis, terminal cancer or chemotherapy, and a diagnosis of mental illness

Primary outcomes:
measure: Mediterranean Diet Score
timeFrame: Change from baseline outcome measure at 8th week (post-test)
measure: Nutrition Knowledge test for the Elderly
timeFrame: Change from baseline outcome measure at 8th week (post-test)
Secondary outcomes:
measure: Montreal Cognitive Assessment score
timeFrame: Change from baseline outcome measure at 8th week (post-test)
measure: Cognitive Failures Questionnaire score
timeFrame: Change from baseline outcome measure at 8th week (post-test)
Other outcomes:
measure: Pittsburgh Sleep Quality Index score
timeFrame: Change from baseline outcome measure at 8th week (post-test)
measure: Center for Epidemiological Studies Depression Scale score
timeFrame: Change from baseline outcome measure at 8th week (post-test)
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
affiliation: Nursing
name: Cheng-Chen Chou
role: PRINCIPAL_INVESTIGATOR
References: