HealthyNCT04788446
Mediterranean Diet Interventions for Eating Behavior and Cognitive Performance Among Older Adults in the Community
A study testing Mini-flipped Game-based Learning and Balanced diet in people with Healthy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Mini-flipped Game-based Learning and Balanced diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jul 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Mini-flipped Game-based Learning, Balanced diet
- Keywords
- Mini-flipped Game-based Learning, Mediterranean Diet, Eating Behavior, Cognitive Performance
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-flipped Game-based LearningBehavioural
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 dietBehavioural
Given a balanced diet nutrition health education manual for the aged.
| Study group | Role | What they receive |
|---|---|---|
| Mini-flipped Game-based Learning | Experimental | 1. group diet education, an interactive food card game, and guidance on the Mediterranean diet
2. once a week for 40 minutes.
3. lasts for 8 weeks Receives: Behavioral: Mini-flipped Game-based Learning |
| Balanced diet | Placebo comparator | 1. given a leaflet on balanced diet and nutrition among the elderly
2. lasts for 8 weeks Receives: Behavioral: Balanced diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediterranean Diet Score
To measure the Mediterranean dietary behavior
Measured: Change from baseline outcome measure at 8th week (post-test)
Nutrition Knowledge test for the Elderly
To measure the nutrition knowledge
Measured: Change from baseline outcome measure at 8th week (post-test)
Secondary outcomes (2)
Montreal Cognitive Assessment score
To measure the objective cognitive function
Measured: Change from baseline outcome measure at 8th week (post-test)
Cognitive Failures Questionnaire score
To measure the subjective cognitive function
Measured: Change from baseline outcome measure at 8th week (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start31 Jul 2020
- Primary completion30 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Chen Chou, National Yang Ming Chiao Tung University
- Investigators
- Cheng-Chen Chou, Principal investigator, Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788446
- Sponsor's protocol ID
- YM109146E
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04788446
- Acronym / sponsor ID
- YM109146E
- Conditions
- Healthy
- Keywords
- Mini-flipped Game-based Learning, Mediterranean Diet, Eating Behavior, Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-flipped Game-based Learning | Experimental | Behavioral: Mini-flipped Game-based Learning1. group diet education, an interactive food card game, and guidance on the Mediterranean diet 2. once a week for 40 minutes. 3. lasts for 8 weeks |
| Balanced diet | Placebo comparator | Behavioral: Balanced diet1. given a leaflet on balanced diet and nutrition among the elderly 2. lasts for 8 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-flipped Game-based LearningThe 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. | Behavioural | Mini-flipped Game-based Learning |
| Balanced dietGiven a balanced diet nutrition health education manual for the aged. | Behavioural | Balanced diet |
Primary outcome
Mediterranean Diet Score
Time frame: Change from baseline outcome measure at 8th week (post-test)
To measure the Mediterranean dietary behavior
Nutrition Knowledge test for the Elderly
Time frame: Change from baseline outcome measure at 8th week (post-test)
To measure the nutrition knowledge
2 secondary outcomes
Montreal Cognitive Assessment score
Time frame: Change from baseline outcome measure at 8th week (post-test)
Cognitive Failures Questionnaire score
Time frame: Change from baseline outcome measure at 8th week (post-test)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Chen Chou principal investigator
Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-flipped Game-based Learning and Balanced diet in people with Healthy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mediterranean Diet Score (time frame: Change from baseline outcome measure at 8th week (post-test)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.