Physical InactivityHABSNCT06038643
Intergenerational Behavioral Intervention to Enhance Physical Activity in Older Adults at Risk for Alzheimer's Disease
A study testing Motivational behavioural intervention and daily activities monitoring in people with Physical Inactivity, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
This is a four-week pilot randomized controlled trial of a behavioral intervention in older adults at risk for Alzheimer's disease. Older participants are a subgroup from the PREVENT-AD longitudinal cohort. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Motivational behavioural intervention and daily activities monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 8 Oct 2023to 30 May 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Participant Inclusion criteria:
Men and women > 60 years Who are current participants of the PREVENT-AD Longitudinal Cohort at McGill University.
No contraindications to MRI Imaging. Normal cognition Not exercising more than 150 minutes of moderate-intensity exercise per week or sitting more than 8 hours per day AND responded "yes" to the question "Do you want to increase your physical activity?" Fluency in English or French Access to a computer or smartphone with internet Normal or corrected-to-normal vision based on the minimal 20/20 standard Ambulatory without significant increase in pain with walking or the assistance of walking devices
Main Participant Exclusion Criteria:
Primary care physician does not approve additional physical activity An inability to ambulate without the assistance of another person or severe pain
Any unstable medical condition:
- History of a psychiatric illness including schizophrenia or Attention Deficit Hyperactivity Disorder (ADHD). History of anxiety or depression accepted if stable on medication for at least 6 months
- Current treatment for cancer - except non-melanoma skin cancer
- Neurological condition (e.g., multiple sclerosis, Parkinson's disease, and stroke)
- Current alcohol or substance abuse
- Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, Deep Venous Thrombosis (DVT) or other unstable cardiovascular condition
- Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac event in the past six months.
Younger Adult Inclusion Criteria:
- Can be identified as child or grandchild of participant (biological or adopted), 14 years or older.
- Can be a young adult (18 years or older) who is not a relative of the main participant, in case a grandchild or child is not available.
- Stable on antidepressants for more than 6 months.
- In contact with the primary participant more than once per 12 months at baseline
- Lives anywhere in Canada if 18 years and older, or anywhere accessible by mail in Quebec if 14 years and older but younger than 18 years.
- Normal or corrected-to-normal vision based on the minimal 20/20 standard to complete the cognitive tasks
- Able to speak, read, and write English or French
- No diagnosis of neurological disease or unstable health condition
Study Partner Exclusion Criteria:
- Not in contact with the primary participant more than once per 12 months at baseline
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
About this study
Official title: The Healthy Aging Brain Study: A Remote Behavioral Intervention to Enhance Physical Activity in Older Adults.
This is a four-week pilot randomized controlled trial of a behavioral intervention in older adults at risk for Alzheimer's disease. Older participants are a subgroup from the PREVENT-AD longitudinal cohort. We will test whether a four-week intergenerational social motivation using a technology-based platform (intervention group) enhances physical activity relative to a control group.
Read the detailed description
This study is a two-arm, single-site randomized controlled trial to test whether a four-week technology-based intergenerational social motivation intervention enhances physical activity in 60 cognitively unimpaired older adults with a first-degree history of Alzheimer's disease. These at-risk older adults will be recruited as a subgroup from a longitudinal cohort at McGill University, PREVENT-AD. At the outset, half of the participants will be randomized to the intergenerational social motivation condition (intervention group) and the other half will be randomized to the control group (1:1). A multimodal AD risk score based on older participants' already acquired AD biomarker, health and cognitive data will be used as strata for randomization to ensure equal assignment of high-risk participants to Intervention and control groups, using a permuted block method with random blocks.
The primary outcome is an increase in step count as measured by accelerometer. Secondary outcomes are an increase in total physical activity, mood, generativity, cognition, and loneliness. After an initial visit consisting of behavioral testing and structural and functional MRI, participants in the intervention group will be paired with younger adults (14 to 40 years) to form intergenerational dyads. Younger adults are either a family member of the older adult or a younger adult recruited from the community. Participants in the intervention group will receive personalized, positive daily messages over a four-week period via their device using the 'Our Family Garden' technology platform. These daily messages combine (1) pro-social goals (donation to charity after reaching exercise goals), (2) intergenerational social engagement, and (3) positive personalized messages from their younger study partners. This study will have 6 visits over a 2-month period in addition to the four-week intervention period (3 months total). Cognitive and behavioral data will be collected at each visit and physical activity data will be collected over the intervention period.
The primary endpoint is defined as the end of the initial period. Data collected are stored in one of three ways; (1) Physical activity monitoring data are extracted from their respective software packages and uploaded directly to a secure data storage environment at a high-performance computing facility. All pen-and-paper psychosocial and neuropsychological assessments are scored and entered in REDCap. Computerized psychosocial assessments are collected directly in REDCap and computerized neuropsychological assessments are entered in REDCap. TextMagic is used to distribute the daily intervention messages. Collected and anonymized survey data are stored on the web application behind an administrative login developed with Django, a high-level Python web framework. All data from REDCap will be exported to CSV files using the data de-identification feature for subsequent analysis with R and SPSS statistical analysis packages. After compiling all data across the 3 different data servers, data will be checked for completeness and correctness using frequency distributions (for missing data and out-of-range values). For the final dataset, the multiple imputations by chained equations (MICE) will be used to input missing values with 10 imputations.
- Conditions
- Physical Inactivity
- Being tested
- Motivational behavioural intervention and daily activities monitoring, Active Control
- Keywords
- Risk Factors, Disease Prevention, Alzheimer's Disease, Motivation
- Medical subject headings
- Sedentary Behavior, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational behavioural intervention and daily activities monitoringBehavioural
Social motivation manipulation, self-transcendence daily messaging, and daily activities monitoring through accelerometry. Participants in this arm will have a study partner who receives daily feedback on the main participant's daily step count.
Active ControlBehavioural
Daily activities monitored through accelerometry.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Social motivation intervention, self-transcendence daily messages, and daily accelerometry. Receives: Behavioral: Motivational behavioural intervention and daily activities monitoring |
| Active Control | Active comparator | Daily accelerometry. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Step Count (Average Steps/Day)
This metric quantifies the change in the average number of steps taken each day, from the baseline period to the 4-week period. It is a marker of change in habitual ambulatory activity.
Measured: 4-week
Secondary outcomes (14)
The Modified Differential Emotions Scale (mDES) Negative Emotions
The Modified Differential Emotions Scale (mDES) Negative Emotions subscale measures the intensity of negative emotional experiences such as sadness, anger, fear, and shame.
Possible scores: min. 0, max. 80 A higher score indicates greater emotional intensity or frequency of the emotions assessed.
Measured: 4 weeks
Generativity - Achievement
This questionnaire measures generativity, which refers to the concern or desire individuals have to contribute to the well-being and development of future generations.
Generative evaluates the extent to which individuals are motivated by generative concerns, including the desire to impact others and future generations; the Achievement subscale specifically captures the orientation toward personal goal attainment, mastery, and the pursuit of success as expressions of generativity.
Scores for the generative achievement subscale ranged between 6 and 36, with higher scores indicating greater generative achievement.
Measured: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Backwards Digit Span
The TestMyBrain Digital Neuropsychology Toolkit Backwards Digit Span assesses working memory by requiring individuals to recall sequences of numbers in reverse order.
In the backward version, the participant is shown a series of numbers in increasing length and asked to recall the numbers in reverse order. This is a test of short-term memory and working memory. This test was adapted from the Wechsler Adult Intelligence Scales. Scores go from 1 to 10. Higher scores are better.
Measured: 4 weeks
Loneliness
University of California, Los Angeles (UCLA) Loneliness Scale. A higher average score indicates greater loneliness. Possible scores: min. 20, max. 80.
Measured: 4 weeks
Modified Differential Emotions Scale (mDES) Positive Emotions
The Modified Differential Emotions Scale (mDES) Positive Emotions subscale measures the intensity of positive emotional experiences such as joy, gratitude, love, and hope.
Possible scores: min. 0, max. 80 A higher score indicates greater emotional intensity or frequency of the emotions assessed.
Measured: 4 weeks
Generativity Desire
The Generative Test measures generativity, which refers to the concern or desire individuals have to contribute to the well-being and development of future generations. The Desire subscale specifically assesses the emotional motivation and intrinsic longing to nurture, support, and positively impact others and future generations.
Scores for the generative desire subscale ranged between 7 and 42, with higher scores indicating greater generative desire.
Measured: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Choice Reaction Time
The TestMyBrain Digital Neuropsychology Toolkit Choice Reaction Time task measures processing speed and attention by assessing how quickly individuals respond to different stimuli.
Measured: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Digit Symbol Matching
The TestMyBrain Digital Neuropsychology Toolkit Digit Symbol Matching task measures processing speed, attention, and visual-motor coordination by requiring rapid matching of symbols to corresponding numbers.
Measured: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Forward Digit Span
The TestMyBrain Digital Neuropsychology Toolkit Forward Digit Span task measures short-term memory by requiring individuals to recall sequences of numbers in the order presented.
In the forward version of TMB Digit Span, the participant is shown a series of numbers in increasing length and asked to recall the numbers in the order displayed. This is a test of short-term memory. This test was adapted from the Wechsler Adult Intelligence Scales. Scores go from 1 to 11. Higher scores are better.
Measured: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance C
The TestMyBrain Digital Neuropsychology Toolkit Gradual Onset Continuous Performance Task measures sustained attention and inhibitory control by requiring individuals to detect target stimuli amid gradually changing non-targets.
In this go/no-go test, the participant presses a button for each city image and withholds button presses for mountain images. This is a test of cognitive control, sustained attention, and response inhibition. Values can be from -1.5 to +1.5. Higher scores indicate better performance. The CPT.C score is a measure of response criterion, or how quickly and/or impulsively the participant tended to respond. Higher scores represent greater response impulsivity.
Measured: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance D
The TestMyBrain Digital Neuropsychology Toolkit Gradual Onset Continuous Performance Task (D) assesses sustained attention and response inhibition by requiring individuals to monitor and respond to target stimuli within a dynamic visual stream.
In this go/no-go test, the participant presses a button for each city image and withholds button presses for mountain images. This is a test of cognitive control, sustained attention, and response inhibition. The CPT.D score is a measure of discrimination performance, related to how accurately the participant was able to respond to mountains and scenes. Higher scores represent better performance. Values can be from 1 to 4. Higher scores indicate better performance.
Measured: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Matrix Reasoning
The TestMyBrain Digital Neuropsychology Toolkit Matrix Reasoning task measures abstract reasoning and fluid intelligence by requiring individuals to identify patterns and complete visual matrices.
In Test my Brain Matrix Reasoning, the participant selects which smaller image completes the pattern in the larger image. This is a test of visual reasoning and general cognitive ability. This test was adapted from the Wechsler Adult Intelligence Scales. Scores go from 2 to 32. Higher scores are better.
Measured: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Serial Reaction Time
The TestMyBrain Digital Neuropsychology Toolkit Serial Reaction Time task measures implicit learning and motor sequence acquisition by assessing response speed to repeating and random stimulus patterns.
In the TMB Serial Reaction Time task, higher scores in seconds (i.e., longer reaction times) indicate:
Reduced processing speed Lower motor or attentional efficiency Weaker implicit sequence learning
Measured: 4 weeks.
Test My Brain Digital Neuropsychology Toolkit - Visual Paired Associates
The TestMyBrain Digital Neuropsychology Toolkit Visual Paired Associates task measures associative memory by requiring individuals to learn and recall visual symbol pairs.
In this test, the participant memorizes a set of picture pairs. Then, after completing TMB Digit Symbol Matching (90 sec), the participant selects which pictures were paired together. TMB Visual PA is a test of visual episodic memory. In TMB Digit SM, the participant matches as many number/symbol pairs as possible in 90 seconds. This is a test of processing speed. Scores go from 4 to 23. Higher scores are better.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start8 Oct 2023
- Primary completion14 Apr 2024
- Study completion30 May 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 Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intergenerational Social Motivation Behavioral Intervention using a Technology-based Platform Our research will test an innovative, technology-based, and readily scalable cross-generational social behavior intervention to enhance physical activity in at-risk older adults through a randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal Neurological Institute and Hospital, McGill University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Maiya R. Geddes, MD, Douglas Mental Health University Institute
- Investigators
- Maiya R Geddes, MD PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038643
- Sponsor's protocol ID
- IUSMD-20-38
- Other IDs
- P30AG048785
- Acronym
- HABS
- Status last verified
- Jul 2025
- First submitted
- 25 Apr 2022
- Last updated
- 9 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healthy Aging Brain Study: A Remote Behavioral Intervention to Enhance Physical Activity in Older Adults.
- ClinicalTrials.gov ID
- NCT06038643
- Acronym / sponsor ID
- HABS / IUSMD-20-38
- Conditions
- Physical Inactivity
- Keywords
- Risk Factors, Disease Prevention, Alzheimer's Disease, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Collaborators
- Montreal Neurological Institute and Hospital, McGill University, National Institute on Aging (NIA)
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 14 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Posted 9 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a four-week pilot randomized controlled trial of a behavioral intervention in older adults at risk for Alzheimer's disease. Older participants are a subgroup from the PREVENT-AD longitudinal cohort. We will test whether a four-week intergenerational social motivation using a technology-based platform (intervention group) enhances physical activity relative to a control group.
Detailed description
This study is a two-arm, single-site randomized controlled trial to test whether a four-week technology-based intergenerational social motivation intervention enhances physical activity in 60 cognitively unimpaired older adults with a first-degree history of Alzheimer's disease. These at-risk older adults will be recruited as a subgroup from a longitudinal cohort at McGill University, PREVENT-AD. At the outset, half of the participants will be randomized to the intergenerational social motivation condition (intervention group) and the other half will be randomized to the control group (1:1). A multimodal AD risk score based on older participants' already acquired AD biomarker, health and cognitive data will be used as strata for randomization to ensure equal assignment of high-risk participants to Intervention and control groups, using a permuted block method with random blocks.
The primary outcome is an increase in step count as measured by accelerometer. Secondary outcomes are an increase in total physical activity, mood, generativity, cognition, and loneliness. After an initial visit consisting of behavioral testing and structural and functional MRI, participants in the intervention group will be paired with younger adults (14 to 40 years) to form intergenerational dyads. Younger adults are either a family member of the older adult or a younger adult recruited from the community. Participants in the intervention group will receive personalized, positive daily messages over a four-week period via their device using the 'Our Family Garden' technology platform. These daily messages combine (1) pro-social goals (donation to charity after reaching exercise goals), (2) intergenerational social engagement, and (3) positive personalized messages from their younger study partners. This study will have 6 visits over a 2-month period in addition to the four-week intervention period (3 months total). Cognitive and behavioral data will be collected at each visit and physical activity data will be collected over the intervention period.
The primary endpoint is defined as the end of the initial period. Data collected are stored in one of three ways; (1) Physical activity monitoring data are extracted from their respective software packages and uploaded directly to a secure data storage environment at a high-performance computing facility. All pen-and-paper psychosocial and neuropsychological assessments are scored and entered in REDCap. Computerized psychosocial assessments are collected directly in REDCap and computerized neuropsychological assessments are entered in REDCap. TextMagic is used to distribute the daily intervention messages. Collected and anonymized survey data are stored on the web application behind an administrative login developed with Django, a high-level Python web framework. All data from REDCap will be exported to CSV files using the data de-identification feature for subsequent analysis with R and SPSS statistical analysis packages. After compiling all data across the 3 different data servers, data will be checked for completeness and correctness using frequency distributions (for missing data and out-of-range values). For the final dataset, the multiple imputations by chained equations (MICE) will be used to input missing values with 10 imputations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intergenerational Social Motivation Behavioral Intervention using a Technology-based Platform Our research will test an innovative, technology-based, and readily scalable cross-generational social behavior intervention to enhance physical activity in at-risk older adults through a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational behavioural intervention and daily activities monitoringSocial motivation intervention, self-transcendence daily messages, and daily accelerometry. |
| Active Control | Active comparator | Behavioral: Active ControlDaily accelerometry. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Motivational behavioural intervention and daily activities monitoringSocial motivation manipulation, self-transcendence daily messaging, and daily activities monitoring through accelerometry. Participants in this arm will have a study partner who receives daily feedback on the main participant's daily step count. | Behavioural | Intervention |
| Active ControlDaily activities monitored through accelerometry. | Behavioural | Active Control |
Primary outcome
Total Step Count (Average Steps/Day)
Time frame: 4-week
This metric quantifies the change in the average number of steps taken each day, from the baseline period to the 4-week period. It is a marker of change in habitual ambulatory activity.
14 secondary outcomes
The Modified Differential Emotions Scale (mDES) Negative Emotions
Time frame: 4 weeks
Generativity - Achievement
Time frame: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Backwards Digit Span
Time frame: 4 weeks
Loneliness
Time frame: 4 weeks
Modified Differential Emotions Scale (mDES) Positive Emotions
Time frame: 4 weeks
Generativity Desire
Time frame: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Choice Reaction Time
Time frame: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Digit Symbol Matching
Time frame: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Forward Digit Span
Time frame: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance C
Time frame: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance D
Time frame: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Matrix Reasoning
Time frame: 4 weeks
Test My Brain Digital Neuropsychology Toolkit - Serial Reaction Time
Time frame: 4 weeks.
Test My Brain Digital Neuropsychology Toolkit - Visual Paired Associates
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maiya R Geddes, MD PhD principal investigator
McGill 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 Motivational behavioural intervention and daily activities monitoring in people with Physical Inactivity, run by Douglas Mental Health University Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Jul 2025. 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 Canada. 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 9 Jul 2025). 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?
Total Step Count (Average Steps/Day) (time frame: 4-week). 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 9 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.