Healthy AgingNCT05506852
Using Teleneuropsychology to Optimize Cognition in Healthy Aging: the Web-based Breakfast Game
A study testing Web-based training strategy and Web-based regular training (no strategy) in people with Healthy Aging, run by Columbia University at 1 site in United States.
Trial summary
Executive control processes involve initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control processes will improve cognitive… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Web-based training strategy and Web-based regular training (no strategy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-75
- Willingness to adhere to training protocol
- Adequate English proficiency
Who cannot join
- Low test scores (below 26 on the Montreal Cognitive Assessment)
- Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance.
- Taking medications known to influence cognitive performance.
- Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.
- Enrolled in a concurrent study that could affect the outcome of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Training Executive Control in Cognitively Healthy Aging: the Web-based Breakfast Game
Executive control processes involve initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control processes will improve cognitive performance in cognitively healthy older adults.
Read the detailed description
The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control / multi-tasking abilities will improve cognitive performance in healthy older adults. Cognitively normal adults aged 60-75 will be randomized into two experimental groups: 1) Web-based game with training strategy; 2) Web-based game without training strategy (Active Control). All participants (groups 1 and 2) will be instructed to play the complex, high-demand online game, Breakfast Game, for 14 one-hour sessions over 5 weeks.
- Conditions
- Healthy Aging
- Being tested
- Web-based training strategy, Web-based regular training (no strategy)
- Keywords
- cognition, cognitive training, non-pharmacological intervention, video game, cognitive enhancement, computer-based, teleneuropsychology, computerized, attention control, executive control, cognitive decline, multi-tasking
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based training strategyBehavioural
Also called Experimental intervention
Participants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion. Participants will learn to play the game using specific strategies, in order to optimize the performance.
Web-based regular training (no strategy)Behavioural
Also called Control intervention
Participants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion. Participants will learn to play the game under regular game instructions.
| Study group | Role | What they receive |
|---|---|---|
| Strategy Training | Experimental | Participants will play the Breakfast Game with training strategy. Receives: Behavioral: Web-based training strategy |
| Regular Approach | Active comparator | Participants will play the Breakfast Game without training strategy. Receives: Behavioral: Web-based regular training (no strategy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Breakfast Game Performance: Number of Tables Set Score
Change in the total number of tables set. In the computerized task, participants are asked to set tables for four guests. When finished, one point is given. Higher scores represent a better outcome. This metric represents a change in the score = the higher means improvement in the performance. The total score ranges between 0 and 12; the total change score ranged from -3 to +3.
Measured: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
Changes in the Breakfast Game Performance: Cooking Time Range of Stop Times Scores
Change in cooking time (milliseconds) between food items. In the computerized task, participants are asked to cook different food types. Scores reflect the difference between the first and last food item that was stopped cooking. Lower scores (closest to zero) represent a better outcome. This metric represents a change in the score = the lower means improvement on the performance. The total score ranges between 0.3 and 315; the total change score ranges from -40 to +40.
Measured: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
Change in Breakfast Game Performance: Cooking Time Discrepancy Scores
Change in cooking time (milliseconds) in each food type. In the computerized task, participants are asked to cook different food types. Scores reflect the average absolute values of the difference between the required and actual cooking time of each item. Lower scores (closest to zero) represent a better outcome. This metric represents a change in the score = the lower means improvement in the performance. The total score ranges between 0.3 and 175; The total change score ranges from -20 to +20.
Measured: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
Transfer to Complex Executive/Attention Control Measure (Proximal Outcome).
Accuracy on the Alphanumeric Task. This metric represents a change in the score. The higher the means more improvement in the performance. The total change score ranged from -0.1 to +0.1
Measured: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
Secondary outcomes (5)
Transfer to Executive Functions Composite Z-Score (Distal Outcome)
The Executive Functions Composite Z-Score represents an ability based on performance in four tests: Letter-Number Sequencing, Wisconsin Card Sorting Test, Stroop, and Useful Field of View. Each of these test measures aspects of executive functions, including: divided attention, working memory, inhibitory control, and cognitive flexibility.
To calculate the Executive Functions Composite Score, Z-score values were computed in each of the four tests. We then averaged the Z-scores into a single Z-score measure. The central value (Z-score of 0) represents the average performance of the sample in each test. Standard deviation above the mean (higher Z-score values) represents better performance. The total Z-score ranged between -7 and 5. (Values not used for clinical diagnosis, sample cognitively healthy).
This metric represents CHANGE in the Executive Functions Composite Score = the higher values represent more improvement in the performance. The total change score ranged from -2 + 2.
Measured: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
Transfer to the General Self-efficacy Scale (Distal Outcome)
Scores on a scale that measures perception about self-efficacy. Total score ranges between 10 and 40, with a higher score indicating more self-efficacy. The change in the scale ranged from -4 to 9. This metric represents a change in the score = the higher means improvement in the performance.
Measured: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
Transfer to Beck Depression Inventory (Distal Outcome)
Score on a scale that measures depression symptoms. Total score ranges between 0 and 63, with a higher score indicating more depression symptoms. The change in the scale ranged from +3 to -9.
Measured: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
Transfer to Beck Anxiety Inventory (Distal Outcome)
Score on a scale that measures anxiety symptoms. Total score ranges between 0 and 63, with a higher score indicating more anxiety symptoms. The change in the scale ranged from +6 to -6.
Measured: Within the 2 weeks before intervention starts, and the 6th week, after the last (13th) training session. (Measure represent the change between pre and post training)
Transfer to Cognition-Leisure Questionnaire (Distal Outcome)
Score on a scale reflecting engagement/frequency in leisure \& cognitive activities. Total score ranges between 0 and 80, with a higher score indicating more frequency in leisure/cognitive activities. The change in the scale ranged from -9 to 9.
Measured: Within the 2 weeks before intervention starts, and the 6th week, after the last (12th) training session. (Measure represent the change between pre and post training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start17 Jan 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sharon Sanz Simon, Columbia University
- Investigators
- Sharon Sanz Simon, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506852
- Sponsor's protocol ID
- AAAT4773
- Other IDs
- 1K99AG078561-01
- Status last verified
- Mar 2026
- First submitted
- 25 Jul 2022
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Executive Control in Cognitively Healthy Aging: the Web-based Breakfast Game
- ClinicalTrials.gov ID
- NCT05506852
- Acronym / sponsor ID
- AAAT4773
- Conditions
- Healthy Aging
- Keywords
- cognition, cognitive training, non-pharmacological intervention, video game, cognitive enhancement, computer-based, teleneuropsychology, computerized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Posted 19 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Executive control processes involve initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control processes will improve cognitive performance in cognitively healthy older adults.
Detailed description
The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control / multi-tasking abilities will improve cognitive performance in healthy older adults. Cognitively normal adults aged 60-75 will be randomized into two experimental groups: 1) Web-based game with training strategy; 2) Web-based game without training strategy (Active Control). All participants (groups 1 and 2) will be instructed to play the complex, high-demand online game, Breakfast Game, for 14 one-hour sessions over 5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategy Training | Experimental | Behavioral: Web-based training strategyParticipants will play the Breakfast Game with training strategy. |
| Regular Approach | Active comparator | Behavioral: Web-based regular training (no strategy)Participants will play the Breakfast Game without training strategy. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60-75
- Willingness to adhere to training protocol
- Adequate English proficiency
Key exclusion criteria (5 listed)
- Low test scores (below 26 on the Montreal Cognitive Assessment)
- Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance.
- Taking medications known to influence cognitive performance.
- Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.
- Enrolled in a concurrent study that could affect the outcome of this study.
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 |
|---|---|---|
| Web-based training strategyAlso: Experimental interventionParticipants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion. Participants will learn to play the game using specific strategies, in order to optimize the performance. | Behavioural | Strategy Training |
| Web-based regular training (no strategy)Also: Control interventionParticipants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion. Participants will learn to play the game under regular game instructions. | Behavioural | Regular Approach |
Primary outcome
Changes in the Breakfast Game Performance: Number of Tables Set Score
Time frame: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
Change in the total number of tables set. In the computerized task, participants are asked to set tables for four guests. When finished, one point is given. Higher scores represent a better outcome. This metric represents a change in the score = the higher means improvement in the performance. The total score ranges between 0 and 12; the total change score ranged from -3 to +3.
Changes in the Breakfast Game Performance: Cooking Time Range of Stop Times Scores
Time frame: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
Change in cooking time (milliseconds) between food items. In the computerized task, participants are asked to cook different food types. Scores reflect the difference between the first and last food item that was stopped cooking. Lower scores (closest to zero) represent a better outcome. This metric represents a change in the score = the lower means improvement on the performance. The total score ranges between 0.3 and 315; the total change score ranges from -40 to +40.
Change in Breakfast Game Performance: Cooking Time Discrepancy Scores
Time frame: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
Change in cooking time (milliseconds) in each food type. In the computerized task, participants are asked to cook different food types. Scores reflect the average absolute values of the difference between the required and actual cooking time of each item. Lower scores (closest to zero) represent a better outcome. This metric represents a change in the score = the lower means improvement in the performance. The total score ranges between 0.3 and 175; The total change score ranges from -20 to +20.
Transfer to Complex Executive/Attention Control Measure (Proximal Outcome).
Time frame: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
Accuracy on the Alphanumeric Task. This metric represents a change in the score. The higher the means more improvement in the performance. The total change score ranged from -0.1 to +0.1
5 secondary outcomes
Transfer to Executive Functions Composite Z-Score (Distal Outcome)
Time frame: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
Transfer to the General Self-efficacy Scale (Distal Outcome)
Time frame: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
Transfer to Beck Depression Inventory (Distal Outcome)
Time frame: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
Transfer to Beck Anxiety Inventory (Distal Outcome)
Time frame: Within the 2 weeks before intervention starts, and the 6th week, after the last (13th) training session. (Measure represent the change between pre and post training)
Transfer to Cognition-Leisure Questionnaire (Distal Outcome)
Time frame: Within the 2 weeks before intervention starts, and the 6th week, after the last (12th) training session. (Measure represent the change between pre and post training)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Sharon Sanz Simon, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based training strategy and Web-based regular training (no strategy) in people with Healthy Aging, run by Columbia University at 1 site in United States.
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 5 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 19 Mar 2026. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in the Breakfast Game Performance: Number of Tables Set Score (time frame: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12). The study lists 4 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 19 Mar 2026.