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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Mini-flipped Game-based Learning; Behavioral: Balanced diet

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).

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheng-Chen Chou, Ph.D.; Phone Number: 7176 +886 2 28267000; Email: chou8278@gmail.com
• Study Contact Backup: Name: Yu-Jen Li; Phone Number: +886 932 857 867; Email: k6262000@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, Taiwan
    • National Yang Ming Chiao Tung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mini-flipped Game-based Learning; group diet education, an interactive food card game, and guidance on the Mediterranean diet; once a week for 40 minutes.; lasts for 8 weeks	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.
Placebo Comparator: Balanced diet; given a leaflet on balanced diet and nutrition among the elderly; lasts for 8 weeks	Behavioral: Balanced diet; Given a balanced diet nutrition health education manual for the aged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mediterranean Diet Score	To measure the Mediterranean dietary behavior	Change from baseline outcome measure at 8th week (post-test)
Nutrition Knowledge test for the Elderly	To measure the nutrition knowledge	Change from baseline outcome measure at 8th week (post-test)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment score	To measure the objective cognitive function	Change from baseline outcome measure at 8th week (post-test)
Cognitive Failures Questionnaire score	To measure the subjective cognitive function	Change from baseline outcome measure at 8th week (post-test)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index score	To measure the Sleep Quality	Change from baseline outcome measure at 8th week (post-test)
Center for Epidemiological Studies Depression Scale score	To measure the Depression	Change from baseline outcome measure at 8th week (post-test)

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Principal Investigator: Cheng-Chen Chou, Nursing

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Mediterranean Diet; Eating Behavior; Cognitive Performance; Mini-flipped Game-based Learning
• Other Study ID Numbers: YM109146E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No