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

Not Applicable

Completed

• Conditions: Physical Inactivity
• Interventions: Behavioral: Active Control; Behavioral: Motivational behavioural intervention and daily activities monitoring

• 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.

Study Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Start: 2023-10-08
• Primary Completion: 2024-04-14
• Study Completion: 2024-05-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Arm && Interventions

Group	Intervention	Description
Active Control	Active Control	Daily accelerometry.
Intervention	Motivational behavioural intervention and daily activities monitoring	Social motivation intervention, self-transcendence daily messages, and daily accelerometry.

Primary Outcome Measures

Name	Time	Method
Total step count (average steps/day)	Baseline; 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
Total Physical Activity (average min/day)	Baseline; 4-week	This metric quantifies the change in the average amount of time spent engaged in light, moderate, or vigorous physical activity each day, from the baseline period to the 4-week followup period. It is a marker of physical activity.
Modified Differential Emotions Scale	Baseline; 4-week	A questionnaire that assesses mood and feelings. Possible scores: min. 0, max. 80 A higher score indicates greater emotional intensity or frequency of the emotions assessed.
Generativity Questionnaire	Baseline; 4-week	This questionnaire generativity, which refers to the concern or desire individuals have to contribute to the well-being and development of future generations.
Test My Brain Digital Neuropsychology Toolkit	Baseline; 4-week	This metric assessed cognitive status across multiple domains (e.g., memory, executive function, processing speed)
Loneliness	Baseline; 4-week	University of California, Los Angeles (UCLA) Loneliness Scale. A higher average score indicates greater loneliness. Possible scores: min. 20, max. 80.

Trial Locations

Locations (1)

Douglas Mental Health University Institute; 🇨🇦 Montréal, Quebec, Canada