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Completed

NCT Number: NCT04788446

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.

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Key information

Conditions

Healthy Behavior Behavior, Animal Feeding Behavior

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming Chiao Tung University

Taipei, Taiwan, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini-flipped Game-based Learning

Behavioral

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

Behavioral

Given a balanced diet nutrition health education manual for the aged.

Primary outcomes

  1. Mediterranean Diet Score

    Time frame: Change from baseline outcome measure at 8th week (post-test)

    To measure the Mediterranean dietary behavior

  2. Nutrition Knowledge test for the Elderly

    Time frame: Change from baseline outcome measure at 8th week (post-test)

    To measure the nutrition knowledge

Secondary outcomes

  1. Montreal Cognitive Assessment score

    Time frame: Change from baseline outcome measure at 8th week (post-test)

    To measure the objective cognitive function

  2. Cognitive Failures Questionnaire score

    Time frame: Change from baseline outcome measure at 8th week (post-test)

    To measure the subjective cognitive function

Other outcomes

  1. Pittsburgh Sleep Quality Index score

    Time frame: Change from baseline outcome measure at 8th week (post-test)

    To measure the Sleep Quality

  2. Center for Epidemiological Studies Depression Scale score

    Time frame: Change from baseline outcome measure at 8th week (post-test)

    To measure the Depression

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2021
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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