Mediterranean Diet Interventions for Eating Behavior and Cognitive Performance Among Older Adults in the Community

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788446
• Other study ID #: YM109146E
• Status: Completed
• Phase: N/A
• Start date: July 31, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: March 2023
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 31, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Mini-flipped Game-based Learning
The intervention was 8 weeks, forty minutes adjusted Mediterranean diet learning plan once a week, which includes the 20 minutes for the Mediterranean food table game, and the 20 minutes for the Mediterranean diet nutrition course. The topic of the course includes the relationship between Mediterranean diet and dementia, knowledge of Mediterranean diet, how to integrate local food ingredients into the Mediterranean diet, etc.
• Balanced diet
Given a balanced diet nutrition health education manual for the aged.

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pittsburgh Sleep Quality Index score	To measure the Sleep Quality	Change from baseline outcome measure at 8th week (post-test)
Other	Center for Epidemiological Studies Depression Scale score	To measure the Depression	Change from baseline outcome measure at 8th week (post-test)
Primary	Mediterranean Diet Score	To measure the Mediterranean dietary behavior	Change from baseline outcome measure at 8th week (post-test)
Primary	Nutrition Knowledge test for the Elderly	To measure the nutrition knowledge	Change from baseline outcome measure at 8th week (post-test)
Secondary	Montreal Cognitive Assessment score	To measure the objective cognitive function	Change from baseline outcome measure at 8th week (post-test)
Secondary	Cognitive Failures Questionnaire score	To measure the subjective cognitive function	Change from baseline outcome measure at 8th week (post-test)