Intergenerational Behavioral Intervention to Enhance Physical Activity in Older Adults at Risk for Alzheimer's Disease

Not Applicable

Completed

Conditions: Physical Inactivity

Registration Number: NCT06038643

Lead Sponsor: Douglas Mental Health University Institute

Brief 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. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 76

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Step Count (Average Steps/Day)	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.

Secondary Outcome Measures

Name	Time	Method
The Modified Differential Emotions Scale (mDES) Negative Emotions	4 weeks	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.
Generativity - Achievement	4 weeks	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.
Test My Brain Digital Neuropsychology Toolkit - Backwards Digit Span	4 weeks	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.
Loneliness	4 weeks	University of California, Los Angeles (UCLA) Loneliness Scale. A higher average score indicates greater loneliness. Possible scores: min. 20, max. 80.
Modified Differential Emotions Scale (mDES) Positive Emotions	4 weeks	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.
Generativity Desire	4 weeks	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.
Test My Brain Digital Neuropsychology Toolkit - Choice Reaction Time	4 weeks	The TestMyBrain Digital Neuropsychology Toolkit Choice Reaction Time task measures processing speed and attention by assessing how quickly individuals respond to different stimuli.
Test My Brain Digital Neuropsychology Toolkit - Digit Symbol Matching	4 weeks	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.
Test My Brain Digital Neuropsychology Toolkit - Forward Digit Span	4 weeks	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.
Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance C	4 weeks	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.
Test My Brain Digital Neuropsychology Toolkit - Gradual Onset Continuous Performance D	4 weeks	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.
Test My Brain Digital Neuropsychology Toolkit - Matrix Reasoning	4 weeks	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.
Test My Brain Digital Neuropsychology Toolkit - Serial Reaction Time	4 weeks.	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
Test My Brain Digital Neuropsychology Toolkit - Visual Paired Associates	4 weeks	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.

Trial Locations

Locations (1): Douglas Mental Health University Institute
🇨🇦
Montréal, Quebec, Canada
Douglas Mental Health University Institute
🇨🇦Montréal, Quebec, Canada