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| ID | Type | Description | Link |
|---|---|---|---|
| 1K99AG078561-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strategy Training | Experimental | Participants will play the Breakfast Game with training strategy. |
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| Regular Approach | Active Comparator | Participants will play the Breakfast Game without training strategy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based training strategy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Sanz Simon, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion.
Data access requests will be reviewed by the principal investigator.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental (Breakfast Game With Emphasis Change) | 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. |
| FG001 | Control (Breakfast Game Without the Emphasis Change) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group (Breakfast Game With Emphasis Change) | Behavioral: Web-based training strategy As designed, participants (N=19) underwent a web-based training protocol where they played an online game that simulates a breakfast environment and performed everyday activities, such as "cooking" and "setting tables" in a multi-tasking fashion. Participants learnt to play the game using specific strategies in order to optimize their performance. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale (change) | Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12 |
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From enrollment until the end of follow-up, up to 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strategy Training | Participants will play the Breakfast Game with training strategy. Web-based training strategy: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon Sanz Simon | Columbia University (previous); Rutgers University (current) | 973-972-2977 | sharon.sanzsimon@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan | Jan 15, 2026 | Mar 18, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Participants will not be aware of the difference across the two conditions.
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| Web-based regular training (no strategy) | Behavioral | 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. |
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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 |
| 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) |
| 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. | 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. | 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. | 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. | 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) |
| BG001 | Control Group (Breakfast Game Without the Emphasis Change) | Behavioral: Web-based regular training (no strategy) Participants (n=19) underwent a web-based training protocol where they played an online game that simulates a breakfast environment and performed everyday activities, such as "cooking" and "setting tables" in a multi-tasking fashion. Participants learnt to play the game under regular game instructions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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Breakfast Game without the Emphasis Change Strategy |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12 |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12 |
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| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale (change) | 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) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale (change) | 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) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale (change) | 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) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale (change) | 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) |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Regular Approach | Participants will play the Breakfast Game without training strategy. Web-based regular training (no strategy): 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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