Cognitive FrailtyGAHOCONNCT05207930
GAmified HOme-based COgnitive-Nutritional Training Feasibility Study
A study testing GAmified HOme-based COgnitive-Nutrition training (GAHOCON) and Centre-based online open-source cognitive games in people with Cognitive Frailty and Protective Diet Adherence, run by The Hong Kong Polytechnic University.
Trial summary
Background: Cognitive frailty is an at-risk state of dementia that it can be reversed by manipulating the lifestyle factors, such as cognitive activity and nutrition/dietary pattern. Their protective effects depend on a prolonged adherence to these factors. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Frailty, Protective Diet Adherence, Cognitive Function
- What is being tested?
- GAmified HOme-based COgnitive-Nutrition training (GAHOCON) and Centre-based online open-source cognitive games
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 14 May 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years,
- Community-dwelling, as defined by living at home without staying in long-term care facilities (e.g., nursing home) in the last 12 months as reported by the participants,
- Cognitive frailty, as defined by co-existence of mild cognitive impairment and physical frailty,7
- Mild cognitive impairment, measured by Montreal Cognitive Assessment (MoCA) score ≤ 25 and Clinical Dementia Rating (CDR) score = 0.5,35,36 and
- Frailty status from pre-frail to frail, measured by Fried Frailty Phenotype score ≥ 1.37
- Poor Mediterranean diet adherence, measured by MDS score < 30.5 (i.e., the mean MDS of community-dwelling older people reported in a local study),20 and
- Functionally independent on food preparation, as defined by Lawton Instrumental Activity of Daily Living score ≥ 15/18 with the sub-score on Meal Preparation = 2/2.38,39
Who cannot join
- Diagnosed dementia, according to subjects' medical record, or
- Probable dementia, as defined by MoCA ≤ 18,35,36
- Low vision (at least one eye with visual acuity < 20/60) or without corrective lens, because all training are visual-based and blurred vision negatively affects cognitive performance in cognitive training and assessment.40
About this study
Official title: GAmified HOme-based COgnitive-Nutritional Training (GAHOCON) for Older People With Cognitive Frailty: A Feasibility Study
Background: Cognitive frailty is an at-risk state of dementia that it can be reversed by manipulating the lifestyle factors, such as cognitive activity and nutrition/dietary pattern. Their protective effects depend on a prolonged adherence to these factors. However, in the literature, most of the cognitive interventions are centred-based and supervised. Nutrition intervention depends on the provision of supplement or a complimentary supply of food. There is a lack of interventions with components of sustaining cognitive and nutrition training effect for the community-dwelling older people with cognitive frailty in home settings.
Objectives: This study aims to examine the feasibility and preliminary effects of a gamified, home-based, cognitive-nutritional training (GAHOCON) programme for community-dwelling older people with cognitive frailty on protective diet adherence, cognitive function, frailty nutrition, and body composition.
Read the detailed description
Methods: This study employs a pilot randomized controlled trial design. Recruitment will be conducted in elderly community centres. Participants who are aged ≥ 60 years, community-dwelling, and having cognitive frailty will be recruited. Participants will be randomized into either intervention or control group at a 1:1 ratio by permuted block randomization with a block size of 8 people. In the intervention group, participants will attend both centre-based training for one month and home-based training for 2 months. Health education on cognitive frailty and nutrition are included in the centre-based training. GAHOCON is included in the home-based training. The gamified cognitive-nutritional training employs digital gaming technology to develop a programme by combining cognitive training and nutrition education to promote the health of older people cognitive frailty. In the control group, participants will attend only the centre-based training. For the outcomes, this study will measure the feasibility in terms of the willingness of participants to be randomized, study participation rate, follow-up rates, response rates to questionnaires, adherence rate, level of participation of the tablet-based training, and time needed for data collection. Adherence to protective diets, cognitive function, frailty, nutrition, and body composition will be measured at baseline (T0), immediately after the completion of the intervention (T1). Convenience sampling will be employed to recruit 30-40 subjects for pilot testing. Feasibility indexes will be reported by descriptive statistics, such as mean with standard deviation and frequency with percentage. To test the hypothesis on the effects, a non-parametric test (i.e., Wilcoxon Signed-rank test) will be used to compare the outcome variables across time points to test the within-group effect in both groups separately. The level of significance was 0.05.
Significance: If this intervention is feasible and effective, this is going to provide a first of its kind home-based intervention to promote both cognitive functions and modify the dietary pattern of older people with cognitive frailty. First, it changes the cognitive training mode from a centre-based and supervised one to a home-based, self-paced, and tele-monitored one. Home-based training enables a more sustainable engagement of training for older people. This is particularly important during the COVID-19 pandemic period when all the elderly centres are closed. Home-based interventions are more accessible and convenient. It also solves the problem of space limitation in elderly centres in the community that more beneficiaries can be covered in space-limiting elderly centres. Second, it changes the mode of nutritional intervention from a supplement-based one to a daily-diet-based one. This intervention could enhance the nutrition and change their dietary pattern of community-dwelling older people with cognitive frailty by engaging them to protective diets, which ensures the sustainability of the beneficial effects of the protective diets towards cognitive frailty. Third, it changes the training mode from a training- and learning-oriented one to a gaming-oriented one. It brings more joy to community-dwelling older people even at the time when they are at home. It also fosters training adherence.
- Conditions
- Cognitive Frailty, Protective Diet Adherence, Cognitive Function, Frailty, Nutrition, Body Composition
- Being tested
- GAmified HOme-based COgnitive-Nutrition training (GAHOCON), Centre-based online open-source cognitive games
- Keywords
- Cognitive frailty, Randomized controlled trial, Nutrition, Protective diets, Gamification, Home-based intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAmified HOme-based COgnitive-Nutrition training (GAHOCON)Device
A home-based tablet game training, in which participants are expected to apply the nutrition knowledge they learn from the centre-based nutritional education and their cognitive functions.
Participants in the intervention group are expected to engage in the home-based training regularly during those 8 weeks. A team of registered social workers working in the elderly community centre will monitor the progress, remind, set goals, and provide supports to the participant remotely on WhatsApp.
Centre-based online open-source cognitive gamesDevice
During the 8 weeks in which the intervention group receives GAHOCON treatment, the control group will be introduced to some online open-source cognitive games (e.g. CogniFit) and are encouraged to play those games at the elderly community centre. However, the content of these games are unrelated to nutrition and the training is gamified to a less extent compared to GAHOCON. They will have free access to these online open-source cognitive games at the elderly community centre.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This arm will undertake a centre-based health education on nutrition and cognitive frailty for 4 weeks, followed by an 8-week homed based gamified cognitive-nutrition training (GAHOCON). Receives: Device: GAmified HOme-based COgnitive-Nutrition training (GAHOCON) |
| Control Group | Placebo comparator | This arm will undertake the same centre-based health education on nutrition and cognitive frailty for 4 weeks but will be opened to undertake a remotely supervised online open-source cognitive games, with which the contents are unrelated to nutrition, at the elderly community centre. Receives: Device: Centre-based online open-source cognitive games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Mediterranean diet
Mediterranean diet was measured by the MedDietScore (MDS). The MDS covers two categories of items: beneficial foods (i.e., non-refined cereals, potatoes, fruits, vegetables, legumes, fish, and olive oil) and detrimental foods (i.e., red meat and products, poultry, full-fat dairy products, and alcohol). The MDS has demonstrated good criterion validity, showing a strong association with plasma and dietary fatty acids, and cardiovascular risks. Each MDS item is scored on a Likert scale from 0 to 5 to indicate the frequency of consumption, ranging from "never" to "daily" Summed MDS scores range from 0 to 55. A higher MDS indicates better adherence to the Mediterranean diet.
Measured: Change is being assessed at 'baseline' (T0) and 'immediately after the completion of intervention' (T1), being 12 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 May 2022 (estimated)
- Primary completion14 May 2022 (estimated)
- Study completion14 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive FrailtyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 40 eligible subjects will be randomly assigned into 2 groups, with block sizes of 8 people in a ratio of 1:1. The intervention group will undertake a 4-week centre-based training followed by an 8-week home-based gamified cognitive-nutrition training (i.e., GAHOCON). Meanwhile, the control group will also receive the same 4-week centre-based training. Afterwards, the control group will be introduced to some open-source cognitive game and will be encouraged to participate in these games in the elderly centre. In other words, the control will not receive the GAHOCON treatment at all.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah College, Mindvivid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207930
- Sponsor's protocol ID
- G-UAMH
- Acronym
- GAHOCON
- Status last verified
- Oct 2021
- First submitted
- 12 Jan 2022
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwan RYC, Law QPS, Tsang JTY, Lam SH, Wang KT, Sin OSK, Cheung DSK. The Effect of the Mediterranean Diet-Integrated Gamified Home-Based Cognitive-Nutritional (GAHOCON) Training Programme for Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Rehabil Assist Technol. 2024 Dec 13;11:e60155. doi: 10.2196/60155.
PubMed 39671585
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAmified HOme-based COgnitive-Nutritional Training (GAHOCON) for Older People With Cognitive Frailty: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05207930
- Acronym / sponsor ID
- GAHOCON / G-UAMH
- Conditions
- Cognitive Frailty, Protective Diet Adherence, Cognitive Function, Frailty, Nutrition, Body Composition
- Keywords
- Cognitive frailty, Randomized controlled trial, Nutrition, Protective diets, Gamification, Home-based intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Tung Wah College, Mindvivid
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 14 May 2022 (estimated)
- Study completion
- 14 May 2022 (estimated)
- First posted
- 26 Jan 2022 (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.
Background: Cognitive frailty is an at-risk state of dementia that it can be reversed by manipulating the lifestyle factors, such as cognitive activity and nutrition/dietary pattern. Their protective effects depend on a prolonged adherence to these factors. However, in the literature, most of the cognitive interventions are centred-based and supervised. Nutrition intervention depends on the provision of supplement or a complimentary supply of food. There is a lack of interventions with components of sustaining cognitive and nutrition training effect for the community-dwelling older people with cognitive frailty in home settings.
Objectives: This study aims to examine the feasibility and preliminary effects of a gamified, home-based, cognitive-nutritional training (GAHOCON) programme for community-dwelling older people with cognitive frailty on protective diet adherence, cognitive function, frailty nutrition, and body composition.
Detailed description
Methods: This study employs a pilot randomized controlled trial design. Recruitment will be conducted in elderly community centres. Participants who are aged ≥ 60 years, community-dwelling, and having cognitive frailty will be recruited. Participants will be randomized into either intervention or control group at a 1:1 ratio by permuted block randomization with a block size of 8 people. In the intervention group, participants will attend both centre-based training for one month and home-based training for 2 months. Health education on cognitive frailty and nutrition are included in the centre-based training. GAHOCON is included in the home-based training. The gamified cognitive-nutritional training employs digital gaming technology to develop a programme by combining cognitive training and nutrition education to promote the health of older people cognitive frailty. In the control group, participants will attend only the centre-based training. For the outcomes, this study will measure the feasibility in terms of the willingness of participants to be randomized, study participation rate, follow-up rates, response rates to questionnaires, adherence rate, level of participation of the tablet-based training, and time needed for data collection. Adherence to protective diets, cognitive function, frailty, nutrition, and body composition will be measured at baseline (T0), immediately after the completion of the intervention (T1). Convenience sampling will be employed to recruit 30-40 subjects for pilot testing. Feasibility indexes will be reported by descriptive statistics, such as mean with standard deviation and frequency with percentage. To test the hypothesis on the effects, a non-parametric test (i.e., Wilcoxon Signed-rank test) will be used to compare the outcome variables across time points to test the within-group effect in both groups separately. The level of significance was 0.05.
Significance: If this intervention is feasible and effective, this is going to provide a first of its kind home-based intervention to promote both cognitive functions and modify the dietary pattern of older people with cognitive frailty. First, it changes the cognitive training mode from a centre-based and supervised one to a home-based, self-paced, and tele-monitored one. Home-based training enables a more sustainable engagement of training for older people. This is particularly important during the COVID-19 pandemic period when all the elderly centres are closed. Home-based interventions are more accessible and convenient. It also solves the problem of space limitation in elderly centres in the community that more beneficiaries can be covered in space-limiting elderly centres. Second, it changes the mode of nutritional intervention from a supplement-based one to a daily-diet-based one. This intervention could enhance the nutrition and change their dietary pattern of community-dwelling older people with cognitive frailty by engaging them to protective diets, which ensures the sustainability of the beneficial effects of the protective diets towards cognitive frailty. Third, it changes the training mode from a training- and learning-oriented one to a gaming-oriented one. It brings more joy to community-dwelling older people even at the time when they are at home. It also fosters training adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 40 eligible subjects will be randomly assigned into 2 groups, with block sizes of 8 people in a ratio of 1:1. The intervention group will undertake a 4-week centre-based training followed by an 8-week home-based gamified cognitive-nutrition training (i.e., GAHOCON). Meanwhile, the control group will also receive the same 4-week centre-based training. Afterwards, the control group will be introduced to some open-source cognitive game and will be encouraged to participate in these games in the elderly centre. In other words, the control will not receive the GAHOCON treatment at all.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: GAmified HOme-based COgnitive-Nutrition training (GAHOCON)This arm will undertake a centre-based health education on nutrition and cognitive frailty for 4 weeks, followed by an 8-week homed based gamified cognitive-nutrition training (GAHOCON). |
| Control Group | Placebo comparator | Device: Centre-based online open-source cognitive gamesThis arm will undertake the same centre-based health education on nutrition and cognitive frailty for 4 weeks but will be opened to undertake a remotely supervised online open-source cognitive games, with which the contents are unrelated to nutrition, at the elderly community centre. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 60 years,
- Community-dwelling, as defined by living at home without staying in long-term care facilities (e.g., nursing home) in the last 12 months as reported by the participants,
- Cognitive frailty, as defined by co-existence of mild cognitive impairment and physical frailty,7
- Poor Mediterranean diet adherence, measured by MDS score < 30.5 (i.e., the mean MDS of community-dwelling older people reported in a local study),20 and
- Functionally independent on food preparation, as defined by Lawton Instrumental Activity of Daily Living score ≥ 15/18 with the sub-score on Meal Preparation = 2/2.38,39
Key exclusion criteria (3 listed)
- Diagnosed dementia, according to subjects' medical record, or
- Probable dementia, as defined by MoCA ≤ 18,35,36
- Low vision (at least one eye with visual acuity < 20/60) or without corrective lens, because all training are visual-based and blurred vision negatively affects cognitive performance in cognitive training and assessment.40
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 |
|---|---|---|
| GAmified HOme-based COgnitive-Nutrition training (GAHOCON)A home-based tablet game training, in which participants are expected to apply the nutrition knowledge they learn from the centre-based nutritional education and their cognitive functions. Participants in the intervention group are expected to engage in the home-based training regularly during those 8 weeks. A team of registered social workers working in the elderly community centre will monitor the progress, remind, set goals, and provide supports to the participant remotely on WhatsApp. | Device | Intervention Group |
| Centre-based online open-source cognitive gamesDuring the 8 weeks in which the intervention group receives GAHOCON treatment, the control group will be introduced to some online open-source cognitive games (e.g. CogniFit) and are encouraged to play those games at the elderly community centre. However, the content of these games are unrelated to nutrition and the training is gamified to a less extent compared to GAHOCON. They will have free access to these online open-source cognitive games at the elderly community centre. | Device | Control Group |
Primary outcome
Adherence to the Mediterranean diet
Time frame: Change is being assessed at 'baseline' (T0) and 'immediately after the completion of intervention' (T1), being 12 weeks apart
Mediterranean diet was measured by the MedDietScore (MDS). The MDS covers two categories of items: beneficial foods (i.e., non-refined cereals, potatoes, fruits, vegetables, legumes, fish, and olive oil) and detrimental foods (i.e., red meat and products, poultry, full-fat dairy products, and alcohol). The MDS has demonstrated good criterion validity, showing a strong association with plasma and dietary fatty acids, and cardiovascular risks. Each MDS item is scored on a Likert scale from 0 to 5 to indicate the frequency of consumption, ranging from "never" to "daily" Summed MDS scores range from 0 to 55. A higher MDS indicates better adherence to the Mediterranean diet.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Derived from this study: PubMed 39671585Kwan RYC, Law QPS, Tsang JTY, Lam SH, Wang KT, Sin OSK, Cheung DSK. The Effect of the Mediterranean Diet-Integrated Gamified Home-Based Cognitive-Nutritional (GAHOCON) Training Programme for Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Rehabil Assist Technol. 2024 Dec 13;11:e60155. doi: 10.2196/60155.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GAmified HOme-based COgnitive-Nutrition training (GAHOCON) and Centre-based online open-source cognitive games in people with Cognitive Frailty and Protective Diet Adherence, run by The Hong Kong Polytechnic University.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Adherence to the Mediterranean diet (time frame: Change is being assessed at 'baseline' (T0) and 'immediately after the completion of intervention' (T1), being 12 weeks apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05207930, which also lists 1 linked publication.
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 26 Jan 2022.