Training Executive Control in Cognitively Healthy Aging: the Web-based Breakfast Game
Phase: NA
Conditions: Healthy Aging
Sponsor: Columbia University

 
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STUDY PROTOCOL 
 
Web-based technology and cognitive training: improving executive control in cognitively 
healthy older adults 
 
         Protocol Number: AAAT4773  
 
National Clinical Trial (NCT) Identified Number:  NCT05506852 
 
Principal Investigator: Sharon Sanz Simon 
 
Sponsor: Columbia University  
 
 
Grant Title: Web-based technology and cognitive training: improving executive control in 
cognitively healthy older adults 
 
        Grant Number: K99AG078561 
 
Funded by: NIH - Institute of Aging 
 
 
Version Number:  v.2 
 
 
January 15th , 2026 
 
 
 
 
 
 
 
 
 

 
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Objectives 
We built on our previous brief feasibility study to design a pilot randomized controlled trial (RCT), 
extending the duration, and increasing the frequency and difficulty of the online Breakfast Game. The main aims 
of this RCT were: 1) to assess the recruitment feasibility (e.g., adherence and retention) of the online Breakfast 
Game delivered in a 12-session regimen, 3 times a week; 2) to evaluate the training gains of Breakfast game with 
Emphasis Change (EmCh) strategy (experimental group) over a similar condition with the Breakfast Game 
without strategy (control group), and 3) transfer effects of Breakfast game with EmCh over a similar condition 
with only the Breakfast game, through neuropsychological measures and psychosocial questionnaires; as well as 
the 4) acceptability of the program through a qualitative post-intervention questionnaire. We hypothesized robust 
feasibility and acceptability of the program in both groups, but greater training gains and transfer effects in the 
EmCh group compared to the control group.  
 
Study Design  
This was a randomized, controlled, parallel-group, assessor-blinded clinical trial comparing the effects of 
two conditions in an online cognitive training program (experimental vs. active control) among cognitively 
unimpaired older adults. Following the National Institute of Health for Behavioral Intervention Development 
classification, this study extends our previous feasibility trial stage 1A to stage 1B, targeting the effects of an 
extended pilot protocol using an RCT design.  
Eligible participants were randomly assigned to the two conditions with an allocation ratio of 1:1 in blocks 
of 20 participants. The randomization schedule was generated by the study statistician (through randomize.net) 
and concealed until the eligible participant was ready for enrollment. The study employed a fully remote, online 
design (Figure 1) consisting of a telephone screening, followed by informed consent, baseline assessment, one 
mock/practice session, 12 cognitive training sessions, and post-intervention assessment. To reduce bias, the 
research team conducting the online assessments was blind to the participants’ group allocation, while the 

 
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researchers (including the principal investigator) supervising the online intervention sessions were blind to the 
participants’ assessment performance. Although participants were aware of the two group interventions, they 
were not provided with the overall study hypotheses. Participant recruitment and interventions were conducted 
from February 2023 to July 2024. 
Figure 1. Study Design 
 
 
 
 
 
 
 
 
 
Ethics Approval, Registration, and Online Consent 
The study protocol and documents were reviewed and approved by the Internal Review Board (IRB) of 
the College of Physicians and Surgeons of Columbia University (reference: IRB-AAAT4773). The study was 
conducted according to the Declaration of Helsinki and reported in line with the Consolidated Standards of 
Reporting Trials (CONSORT 2010) guidelines (Supplementary Material, Figure 1S). As the study was 
implemented remotely, before enrollment, the online written informed consent to participate was obtained from 
each participant through a secure electronic signature system after clarifications over the telephone or 
videoconference. The trial was registered on clinicaltrials.gov (NCT05506852; 08/18/2022). The first participant 
was enrolled on 28th of April 2023, and the last participant on 10th of May 2024.   
 
 
 

 
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Recruitment and Eligibility 
Participants were recruited through multiple sources, primarily leveraging Columbia University’s 
RecruitMe platform, a web-based system developed to connect researchers with potential research participants. 
Additional recruitment occurred via clinicaltrials.gov and community outreach through flyers posted in the 
university and communal spaces, emails to university affiliates, health providers, social media, and partnerships 
with organizations serving older adults in New York City (i.e., NGO’s and senior centers). Interested participants 
contacted the research team via email and then underwent telephone screening to determine eligibility. As this 
was an online study, participants living in different states in the USA were allowed to participate. During the 
telephone screening, the study staff assessed study eligibility and clarified topics of the consent process and study 
procedures. If the participants were eligible, they received the consent form via email and then scheduled a follow-
up call. 
Eligible participants were older adults between the ages of 60 and 75 years old, of any gender/sex, or 
racial/ethnic background, who were native English speakers, able to read in English, and willing to adhere to the 
intervention protocol (which included attending 15 online visits over three months). As in our feasibility trial, we 
kept the age range limited to a young older adult group (60 to 75 years old) to attenuate age differences that could 
interfere with the current “proof-of-concept” pilot study. Participants were not required to have a computer or 
internet at home, as the study team would provide a laptop with internet and a mouse during the study. However, 
participants were required to have a minimum computer experience (including using a computer and a mouse) 
based on a score ≥ 10 points on the Computer Proficiency Questionnaire (CPT). Furthermore, if participants had 
no experience using the videoconference platform, instructions and training were provided as needed. Critically, 
participants had to be cognitively unimpaired, based on a score ≥ 26 points on the Montreal Cognitive 
Assessment-video conferencing version (MoCA-VC), and preserved functionality in the Instrumental Activities 
of Daily Living-Extended scale (IADL-X). Participants were excluded if they presented a history of major 
neurological and psychiatric conditions (e.g., stroke, traumatic brain injury, seizure disorders, bipolar disorder, 
schizophrenia, psychosis, substance dependence, or ADHD), or if considered to present cognitive impairment 
based on the comprehensive neuropsychological assessment. Individuals were also excluded if they had a recent 

 
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(i.e., past five years) history of major depressive or anxiety disorders, use of cognition-impairing medications or 
treatments (e.g., chemotherapy), sensory (e.g., visual, auditory) or physical impairments (e.g., severe arthritic) 
that interfered with computer use, or if they were enrolled in a concurrent interventional study.  
 
Baseline Assessment 
Eligible participants underwent neuropsychological assessment over videoconference, which included 
tests of vocabulary (American National Adult Reading Test - AMNART); episodic memory (Selective Reminding 
Test - SRT), and executive functions, attention and speed processing, including: Letter-Number Sequencing 
(Wechsler Adult Intelligence Scale - WAIS-III)63, Stroop Color-Word Test (Delis-Kaplan Executive Function 
System; D-KEFS), Wisconsin Card Sorting Test (WCST - 128 cards - digital version through Milliseconds 
platform), and Useful Field of View (UFOV – digital version through Milliseconds platform).  
Furthermore, participants were asked to perform the Alphanumeric Task (digital version through the 
Milliseconds platform), an experimental dual task shown to be sensitive to cognitive training. This task requires 
participants to perform two tasks simultaneously under different attention allocation demands: they were asked 
to judge the accuracy of a set of visually presented Alphanumeric Equations (by pressing F as false, or T as true). 
The equations were addition or subtraction constructed by combining a letter and a number (1 or 2) in the form: 
letter +/- number = letter (e.g., P+2 = R). At the same time, participants had to perform the Visual Detection task 
when they were presented with a series of white and red rectangles and were asked to detect the red one by 
pressing the space bar key with their left thumb. Depending on the trial, participants were asked to allocate 
attention equally between the tasks (i.e., 50% in each task) or prioritize one task over the other, with different 
emphasis in each task (e.g., 80% in one task, 20% in another task). As detailed elsewhere54, the Alphanumeric 
Task was presented in five blocks, each block was composed with rest (20 second) and five tasks conditions: 1) 
single-task alphanumeric equation, 2) single-task visual detection, 3) dual-task with equal division of attention 
(50%: Equation: 50/50), dual-task with more emphasis on equation (80% Equation: 80/20) and dual-task with 
more emphasis on detection (20% Equation: 20/80). Each task condition lasts 40 seconds and comprises eight 
trials each. 

 
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Furthermore, participants were asked to complete questionnaires, including the Everyday Cognition Scale 
(ECOG-Revised), General Self-Efficacy questionnaire (GSE); Cognitive Leisure Activity Scale (CLAS), Beck 
Depression Inventory (BDI), and Beck Anxiety Inventory (BAI)2.  
 
Intervention 
 
The Breakfast Game 
The Breakfast Game aims to simulate a multitasking virtual environment where the player is asked to 
prepare breakfast, which requires setting tables for guests while concurrently cooking food for the breakfast meal. 
As previously described, in cognitive healthy young52 and older adults73, the game goals were to: (1) set as many 
correct tables as possible, (2) cook each food item in its accurate time (i.e., not over- or undercooking), and (3) 
finish cooking all food items at the same time so they could be served together. Scoring measures combined 
performance on the Table Setting and Cooking tasks, and the overall goal was to achieve a better performance in 
both tasks. Participants were asked to play the game under split-screen mode, in which they were not allowed to 
visualize the two tasks at the same time, simulating two different home environments. Participants were allotted 
a practice/mock session before starting the actual training sessions.  
During the Table Setting Task, participants were instructed to set as many tables as possible (i.e., setting 
plates, knives, forks, and spoons) for four guests. The task followed Western etiquette (i.e., forks should be set 
on the left side of the plate, knives on the right side, and spoons on the right side of the knives).  When setting the 
tables, participants were asked to follow two possible rules: by guest or by tableware. To set the table by guest 
rule, the participant was required to place the complete tableware set for one guest before moving to the next. To 
set the table by tableware rule, the participants had to set each tableware at once for all four guests before moving 
on to the next tableware (e.g., knives down first, then forks, etc.). Rule orders varied across trials and sessions, 
and one point was allocated when a full table was set under the correct rule, resulting in the task score: the Number 
of Correct Tables. 
During the Cooking Task, participants were asked to prepare five food items, each of which had different 

 
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cooking times displayed in minutes (coffee: 4.5, sausage: 3.5, pancakes: 2, egg: 1.5, and toast: 1 min). The 
cooking times were always the same throughout the training. During each trial, visual bars displayed the cooking 
duration for each item. Participants initiated each trial by starting the food item with the longest cooking time 
(i.e., the coffee). To initiate cooking, participants were required to press the “start” button for each food and press 
“stop” once cooking was complete. Ideally, each food item should start “being cooked” at an accurate start time, 
such that cooking all items ended in synchrony and foods could “be served” together. All rounds of the game 
always presented five food items. EmCh instructions varied across game rounds and sessions, focused sometimes 
on the Table task or Cooking task (EmCh instructions detailed below). Two scores were calculated for the 
Cooking task: Cooking Discrepancy (time accuracy of cooking each food) and Cooking Stop Time Difference 
(time synchrony of finishing the foods together). Score calculations are detailed in the Outcomes section. The 
Breakfast Game platform was hosted by the Technion Institute of Technology (Israel), which provided technical 
support. The research team had access to the platform to design training features, monitor participant activity, and 
adherence. 
 
Practice/mock session 
Before starting the actual training program, participants were invited to attend a practice session through 
videoconference with research staff. Participants received instructions on how to access and play the Breakfast 
Game and were incentivized to ask for clarifications. They also received assistance in troubleshooting potential 
technical difficulties (e.g., videoconference issues or bugs in the computer), and guidance on the procedures to 
avoid distractions and interruptions (e.g., a silent environment and cellphones off), including the ideal moments 
to have short breaks (e.g., between game rounds). During the session, the participant shared the screen so the 
research member could observe the session. The participants played 8 short rounds of the game, with progressive 
difficulty. First, they practiced each task separately, and then an easier version of the “real” game: 1) two tasks 
simultaneously but on the same screen (not split screen mode), 2) fewer than 5 food items. In the last two trials, 
participants played the game under the same format as the real game (e.g., split-screen mode and 5 food items). 
This initial session lasted approximately 1 hour. 

 
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Session 1 to 12: Emphasis Change Strategy versus Active Control 
Participants were randomly assigned to one of two groups: the experimental group, which played the 
Breakfast Game with Emphasis Change (EmCh) strategy, or the active control group (No-EmCh), which played 
the game without EmCh instructions. The control group served to account for all training procedures except EmCh 
exposure, allowing the evaluation of its effects on cognition. Therefore, the control group was instructed to treat 
all game elements as equally important, which maintained a fixed attention strategy throughout the task. In 
contrast, the EmCh group received instructions to direct their attention and prioritize different aspects of the game 
across the game rounds, thereby encouraging flexible attention allocation. Examples of EmCh instructions were 
similar to our previous feasibility trial55: 1) Emphasis on the Table Setting Task: “Pay attention to the Table task, 
75% of your scores will be based on it”; 2)Emphasis on the Cooking Task: “Pay attention to the Cooking task, 
75% of your scores will be based on it”; 3) Emphasis on different aspects of the cooking such as 2.1) Emphasis 
on Cooking Discrepancy:  “Pay attention to cooking each food in its accurate time, 75% of your scores will be 
based on it”; 2.2) Emphasis on Cooking Stop Times: “Pay attention to finishing the foods together, 75% of your 
scores will be based on it”.  
The structure of sessions was consistent across the 12 sessions and included: split screen mode, eight game 
rounds lasting 4.5 minutes each, resulting in a session of 45 minutes. Participants were instructed not to complete 
more than one session per day, which was also enforced by the platform, as it would not allow two sessions on 
the same day, and to avoid gaps of more than four days between sessions. The intervention protocol is summarized 
in the Supplementary Material (Figure 2S). Briefly, in session 1, participants from both groups played the game 
without receiving any EmCh instructions, serving as a baseline session. During sessions 2 through 11, the 
experimental group received EmCh instructions, which directed their attention both within the Cooking task only 
and across the Cooking and Table Setting tasks. In contrast, the control group continued to play the game without 
EmCh instructions in all sessions, following the standard gameplay format. Session 12 mirrored session 1 and 
functioned as a post-EmCh assessment, with both groups playing the game without EmCh instructions. 
Furthermore, as illustrated in Figure 1 (highlighted in red and yellow circles), during sessions 1, 10, 11 and 12, 

 
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all participants played the 8 rounds of the game in a “full game” format (Table + Cooking); while in sessions 2 
to 9, the game was played in a “partial” format, with 4 rounds of the game as “cooking only” and 4 rounds as 
“full game”. We implemented this approach to facilitate EmCh use in different game formats. To ensure clarity 
and support adherence to the protocol, the research team monitored participant performance through the platform 
system and supervised sessions 1, 2, 5, and 12 (30% of the sessions) through videoconference.  
 
Outcomes 
 
Recruitment, Adherence, and Retention 
Recruitment was defined as the percentage of potentially eligible participants who approached the team 
and those who were, in fact, enrolled in the study. Recruitment characteristics were described to better map 
potential barriers, difficulties, and interest of participants in being part of the study. Previous remote cognitive 
training to older adults frequently shows high adherence and retention rates, such as 80% to > 94%; therefore, for 
the present study, we conceptualized intervention adherence as at least 80% of session completion (10/12 sessions 
within 6 weeks). Retention rate was conceptualized as the proportion of enrolled participants who completed 
100% of the study, including all intervention sessions and the post-intervention assessment. 
 
Primary Outcomes: Training Gains in the Breakfast Game and Near-Transfer 
Similar to our previous studies, three game outcomes were generated after each game trial: (1) Number of 
Correct Tables, or the number of full tables completed under the correct rule (by tableware or by guest), with 
higher scores reflecting better performance; (2) Cooking Time Discrepancy (in seconds), reflecting the accuracy 
of cooking each food (i.e., the difference between the required and actual cooking times, averaged across all 
foods); and (3) Cooking Stop Time Difference (in seconds), reflecting the synchrony of finishing the foods 
together (i.e., the difference between the first and last food stopped). For both measures, lower scores indicated 
better performance. 

 
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The Alphanumeric Task under the 80% priority condition was one of the primary near transfer outcomes. 
In this condition, the participants were asked to prioritize one task over the other (e.g., Alphanumeric Equation 
or the Visual Detection task); therefore, this condition was the closest related to the EmCh approach, and more 
likely to serve as a transfer measure. The two variables under the 80% priority condition were: 1) Alphanumeric 
Task 80% on Detection Task - Total Correct, and 2) Alphanumeric Task 80% on Equation Task – Total Correct.   
Furthermore, based on a previous model of executive control, we created an Executive Control Composite Score 
based on measures of working memory (Letter-Number Sequencing total score), cognitive flexibility (WSCT – 
perseverative responses), inhibitory control (Stroop Color-Word Test-DKEFS Condition 3 – Inhibition, and 
Condition 4 - Inhibition and Switching), and divided attention (UFOV – Divided Attention Accuracy)66. The 
composite score was created by summing the z-scores of each of the five tests. 
 
Secondary Outcomes: Distant Transfer Outcome 
Additional measures were used to assess potential psychosocial changes after the intervention, including the 
measure of self-efficacy (GSE), engagement in cognitive activities (CLAS), and mood questionnaires targeting 
symptoms of depression (BDI) and anxiety (BAI). 
 
Acceptability: Post-Intervention Questionnaire 
Acceptability was assessed based on participants’ quantitative and qualitative responses in the post-
intervention questionnaire5. Participants were asked to provide scores (0 to 10) and their views on specific aspects 
of the cognitive training program. For instance, they were asked to provide scores on the difficulty and 
enjoyability of the game, clarity of instructions, and accessibility of the platform. They were also asked to rate 
their overall experience in the study. Moreover, participants were asked to answer open-ended questions about 
the game and its influence on their daily lives. 
 
 
 

 
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Statistical Analysis  
For the sample size calculation, we considered our previous preliminary data and the flat rule of thumb of 
at least 30 subjects to estimate a parameter. Therefore, the current sample size (N=38) would overcome the sample 
size from previous similar studies, including 10 young adults, and 15 to 18 older adults per group. The power 
analysis was conducted with the assumption of 5% attrition between evaluations, having 80% power at a=0.05.  
At baseline, the overall sample was described, and comparisons between groups were assessed. The 
Independent samples T-test was applied for the continuous variables, and chi-squared tests were used for the 
categorical variables. All outcomes were analyzed following the intent-to-treat principle. To evaluate intervention 
effects, linear mixed models (LMM) were conducted using the lme4 R package (version 4.5.0). Each model 
included fixed effects for time (pre vs. post; or session 1 vs. session 12 on the Breakfast Game outcomes), group 
(experimental vs. control), and the interaction between time and group, with a random intercept for each 
participant to account for within-subject correlation. Baseline cognitive performance was included as a covariate 
in all LMM to control for individual variability at baseline. The primary analysis tested time-by-group interactions 
in the training gains and near-transfer measures, and the secondary analysis examined interactions in the distant 
transfer measures. Of note, all the Breakfast Game outcomes were based on the trial performance across sessions. 
Multiple-comparison corrections across all six outcomes were performed to control the false discovery 
rate (FDR) using the Benjamini-Hochberg (BH) procedure. Adjusted p-values (q-values) less than 0.05 were 
considered significant. In addition, effect sizes (Cohen’s d) were calculated for the outcome that presented a 
significant time-by-intervention group interaction. All analyses and visualizations were performed using the R 
Studio software (version 4.3.1).  
 
 
 
 
 

 
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Supplementary Material 
 
Figure 1S. CONSORT Check List 
 
 
 

 
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Figure 2S. Intervention Protocol Details