The primary objective of this clinical trial is to test the efficacy of an innovative multimodal eHealth \& mHealth intervention (focused on emphasizing identity/habit and/or self-regulation) on increasing moderate to vigorous (MVPA) across 12 months among newly retired adults not meeting Physical Activity guidelines at study baseline, thus at higher risk of age-related chronic diseases. The secondary objectives are to examine whether these approaches improve physical and mental well-being and health related fitness-outcomes. Principal Research Question 1: Does an intervention focused on identity/habit + self-regulation skills + education (ID) increase moderate-to-vigorous intensity physical activity (MVPA) compared with an intervention focused on self-regulation skills + education (SR), and an education control condition (ED)? Three-arm parallel design single blinded randomized controlled trial. Participants will be randomized to one of three groups (ID, SR, ED) for 12 months duration. * After the initial screening process, eligible participants will be provided with an accelerometer-mailed or delivered in person-to wear for seven consecutive days. Data collected will verify baseline physical activity levels and determine final eligibility based on adherence to physical activity guideline thresholds. * Participants will visit the lab for fitness testing and complete an online questionnaire See below in "detailed description" the breakdown/delivery given for each of the 3 arms.
BACKGROUND: According to the 2021 census, there are 9.7 million people aged 60 or over in Canada, a surge of 8% since the 2016 census. Further, with life expectancy increasing, the prevalence of chronic diseases and conditions such as hypertension, type 2 diabetes, cancer, cognitive decline, frailty, and dementia that are associated with an ageing population are placing increasing pressures on healthcare systems. There is compelling evidence that engaging in regular PA, of at least 150 minutes of moderate to vigorous intensity aerobic PA throughout the week complemented with muscle strengthening activities at least twice a week, can prevent the onset and progress of age-related chronic diseases and positively influence physical and mental health outcomes. Despite these well-documented benefits, 80% of Canadian adults are not meeting the recommended PA guidelines, with levels of PA decreasing steadily with age. Thus, implementing interventions that effectively increase PA to optimize the physical and mental health outcomes is a public health priority. To date, interventions promoting PA have shown mixed results, so there is a need to better understand, and test innovative behavior change techniques. Further, PA interventions have not focused on specific aging subgroups (e.g., 60-70 years, \>80 years), making it difficult to design and implement effective interventions and make suitable recommendations for policy and practice. One of those important groups that has not received enough evidence-based research (only two small studies), are those transitioning into retirement (i.e., 60-70 years). Transitioning into retirement is established as a seminal period where significant altercations in lifestyle (e.g., reframing of identity, lack of routine) present an opportunity to promote PA. TARGET POPULATION: Participants will be: 1. aged between 60 -70 years, living in Victoria, British-Columbia, Canada. 2. recently retired (within 1.5 years) from occupational work 3. have an internet connection with a computer or smartphone 4. able to engage in MVPA independently, 5. participate in MVPA below Canadian recommended aerobic guidelines (\<150 minutes of MVPA per week, screened by Godin's Leisure Time Exercise Questionnaire. The researcher will also screen participants on baseline accelerometry results (as a secondary assurance). Those participants above the Canadian recommended guidelines will be excluded from the trial. SAMPLE SIZE : 159 participants, 53 participants per group Participants will then be randomized into one of the three conditions (post accelerometer screening): * 1\) The ID condition will be comprised of a 6-week, 10 module format, covering all reflective, regulatory, and reflexive processes. * 2 The SR condition will have access to modules 1 through 6 (reflective and regulatory processes) * 3 The ED condition will have access to modules 1 to 3 (reflective processes). * Additional modules (4 in SR, 7 in ED) will be included in the SR and ED conditions to ensure equivalence of dose across conditions. * These additional modules will focus on general retirement considerations such as travel, socializing, and financial planning with the same style and formatting as the PA modules. * All groups will receive support/booster check-ins on the same material as their intervention designation at 3-,6-, and 12 weeks and 6-months. * After the initial 6-week intervention period, participants will be given follow-up online questionnaires and accelerometers. * This will follow a similar protocol for the 3-, 6- and 12-month time period (6-month assessment will include fitness testing). * In addition, all participants will be asked to participate in an end-of-trial semi-structured interview (at 6-months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
159
The Digital Health Online Platform has 10 lessons that the participant will gain access to on a weekly basis. The Self Regulation (SR) Intervention Condition will have access to Lessons 1 through 6 (reflective and regulatory processes). Lesson titles are as follows: Lesson 1: Why Physical Activity Matters During Retirement Lesson 2: Physical Activity Enhances Your Mood and Wellbeing Lesson 3: Social Connections, Confidence and Enjoyment: Keys to an Active Life Lesson 4: Setting Goals and Planning Ahead for Active Living Lesson 5: Staying on Track: Monitoring Your Activity on Your Own and With Others Lesson 6: How to Keep Moving When You Don't Feel Like It 4 additional lessons will be included in the SR condition to ensure equivalence of dose across conditions.
The Digital Health Online platform has 10 lessons that the Identity (ID) Intervention Condition participant will gain access to on a weekly basis. Lesson titles are as follows: Lesson 1: Why Physical Activity Matters During Retirement Lesson 2: Physical Activity Enhances Your Mood and Wellbeing Lesson 3: Social Connections, Confidence and Enjoyment: Keys to an Active Life Lesson 4: Setting Goals and Planning Ahead for Active Living Lesson 5: Staying on Track: Monitoring Your Activity on Your Own and With Others Lesson 6: How to Keep Moving When You Don't Feel Like It Lesson 7: How to Build Lasting Habits Lesson 8: Habits That Last: Staying Active Through Change Lesson 9: Who You Are When You Move: Understanding and Building Identities Lesson 10: Staying Connected and True to Your Values
Control Group will have access to education lessons 1 to 3 (reflective processes). 7 additional education lessons are included in the Control Education group to ensure equivalence of dose across conditions. Participants will be provided with an accelerometer-mailed or delivered-to wear for seven consecutive days. Following accelerometer wear, participants will complete an online questionnaire and attend the laboratory for fitness testing. All groups will receive support/booster check-ins on the same material as their intervention designation at 3-,6-, and 12 weeks and 6-months. - After the initial 6-week intervention period, participants will be given follow-up online questionnaires and accelerometers. - This will follow a similar protocol for the 3-, 6- and 12-month time period (6-month assessment will include fitness testing). - In addition, all participants will be asked to participate in an end-of-trial semi-structured interview (at 6-months).
University of Victoria
Victoria, British Columbia, Canada
MVPA
Primary Outcome - MVPA will be measured with wGT3X-BT ActiGraph accelerometers, the gold standard for PA measurement in field settings. Participants will wear the devices during waking hours on a belt around the waist (with the device positioned above the right iliac crest) for seven consecutive days. Valid cut-points (counts per minute) for adults will be used to classify MVPA. For a day to be considered valid, there will need to be a minimum of 300 minutes (6 hours) within a 24-hour period of valid wear time.Missing data will be modelled from available data.
Time frame: From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months )
Secondary Outcome Health-Related Fitness Measure 1 - Body Mass Index (BMI)
Secondary Outcome Measure 1 Title: Body Mass Index (BMI) Description: Body mass (kg) and height (cm) will be measured using standard procedures and combined to calculate BMI (kg/m²). Unit of Measure: kg/m² Time Frame: Baseline and 6 months
Time frame: At Baseline & 6 Months
Secondary Outcome Health-Related Fitness Measure 2 - Waist Circumference
Secondary Outcome Measure 2 Title: Waist Circumference Description: Waist circumference (cm) will be measured using standardized anthropometric procedures. Unit of Measure: cm Time Frame: Baseline and 6 months
Time frame: Time Frame: Baseline and 6 months
Secondary Outcome Health-Related Fitness Measure 3 - Cardiovascular Fitness
Secondary Outcome Measure 3 Title: Cardiovascular Fitness Description: Cardiovascular fitness will be assessed using the YMCA submaximal cycle ergometer test, with estimated cardiorespiratory fitness derived according to standard protocols. Unit of Measure: Estimated VO₂ (mL/kg/min) or workload-based estimate (choose whichever you will report) Time Frame: Baseline and 6 months
Time frame: Time Frame: Baseline and 6 months
Secondary Outcome Health-Related Fitness Measure 4 - Upper-Body Strength
Secondary Outcome Measure 4 Title: Upper-Body Strength - 30 second bicep curl strength test Description: Upper-body strength will be assessed using the 30-second bicep curl test. The test involves performing as many arm curls as possible in 30 seconds, while sitting in a chair holding a dumbbell in the dominant arm. Test purpose: This test measures upper body strength and endurance. Unit of Measure: repetitions Time Frame: Baseline and 6 months
Time frame: Time Frame: Baseline and 6 months
Secondary Outcome Health-Related Fitness Measure 5 - Lower-Body Strength
Secondary Outcome Measure 5 Title: Lower-Body Strength Description: Lower-body strength and power will be assessed using the 30-second chair stand test. Unit of Measure: repetitions Time Frame: Baseline and 6 months
Time frame: Time Frame: Baseline and 6 months
Secondary Outcome Health-Related Fitness Measure 6 - Flexibility
Secondary Outcome Measure 6 Title: Flexibility Description: Flexibility will be assessed using the sit-and-reach test. Unit of Measure: cm Time Frame: Baseline and 6 months
Time frame: Time Frame: Baseline and 6 months
Secondary Outcome Measure: Reflective Processes
Reflective Processes Description: Attitudes and perceived capability and opportunity will be assessed using M-PAC self-report items rated on 7-point bipolar Likert scales, with higher scores indicating stronger reflective processes. Unit of Measure: score on 7-point scale Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary Outcome Measure: Regulatory Processes
Regulatory Processes Description: Regulatory processes will be assessed using the Physical Activity Regulation Scale (PARS). Items are rated on a 7-point Likert scale, with higher scores indicating greater use of self-regulatory strategies. Unit of Measure: score on 7-point scale Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary Outcome Measure: Reflexive Processes - Habit Automaticity (Self-Report Habit Index - Automaticity Subscale)
Habit automaticity will be assessed using the Automaticity Subscale of the Self-Report Habit Index (SRHI), a validated self-report questionnaire measuring the extent to which a behavior is performed automatically. Participants rate each item on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate stronger habit automaticity. Unit of Measure: Score on the Automaticity Subscale (range: mean item score on 1-5 scale)
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary Outcome Measure: Reflexive Processes - Identity
Reflexive Processes - Identity Description: Exercise identity will be assessed using the Exercise Identity Scale. Items are rated on a 7-point Likert scale, with higher scores indicating stronger exercise identity. Unit of Measure: score on 7-point scale Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
Social Identity & Prior Identity
Social Identity Social identity will be assessed using the Multidimensional Inventory of Physical Activity Identity (25-item version). Items are rated on 7-point Likert scales (1-7), with higher scores indicating stronger social physical activity identity. Prior Identity Prior physical activity identity will be assessed using retrospective self-report items assessing identity "when younger" (e.g., when describing oneself to others in earlier life). Items are rated on 7-point Likert scales (1-7), with higher scores indicating stronger prior physical activity identity.
Time frame: From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months )
Well-being outcomes
6\. Well-being (Psychological Flourishing) Description: Psychological well-being will be assessed using the Flourishing Scale. The scale includes 8 items assessing self-perceived success in areas such as relationships, self-esteem, purpose, and optimism. Items are rated on a 7-point Likert scale (range: 1-7) and summed to produce a total flourishing score, with higher scores indicating greater psychological flourishing.
Time frame: From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months)
Subjective norm - Descriptive
Subjective Norm - Descriptive Description: Descriptive subjective norm will be assessed using M PAC self report items rated on a 7 point Likert scale, with higher scores indicating stronger perceived norms. Unit of Measure: score on 7 point scale Time Frame: Baseline, 6 weeks, 3 months, 6 months
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months
Subjective norm - Injunctive
21\. Subjective Norm - Injunctive Description: Injunctive Description: Injunctive subjective norm will be assessed using M PAC self report items rated on a 7 point Likert scale, with higher scores indicating stronger perceived social approval. Unit of Measure: score on 7 point scale Time Frame: Baseline, 6 weeks, 3 months, 6 months Time Frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months
Relatedness
Relatedness Description: Relatedness will be assessed using the relatedness subscale of the Basic Psychological Need Satisfaction and Frustration Scale. Items are rated on a 5 point Likert scale, with higher scores indicating greater perceived relatedness. (8 items total, but only using 4 satisfaction items) Unit of Measure: score on 5 point scale Time Frame: Baseline, 6 weeks, 3 months, 6 months
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months
Perceived mental and physical health
Perceived Mental and Physical Health Description: Perceived mental and physical health will be assessed using the 12-Item Short Form Health Survey (SF-12). The survey yields a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. Scores are standardized (range: 0-100), with higher scores indicating better perceived physical and mental health.
Time frame: From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months)
Sociodemographic variables
Sociodemographic variables will be collected at baseline including age, sex, gender, marital status, highest level of education, current employment status, income, ethnicity, PA history. We will disaggregate and analyze all primary and secondary outcomes by gender and sex. Other demographic (e.g., age, ethnicity) variables that intersect with gender will also be considered. The approach recommended by experts in gender related measures is the two-step approach (Centre of Excellence for Transgender Health), which involves asking participants about both their current gender identity and their sex assigned at birth. Specific M-PAC constructs (e.g., perceived capability, habit, identity) may vary by sex and gender, thus targeting these considerations may maximize the potential effectiveness of PA interventions
Time frame: Sociodemographic variables will be collected at baseline
Personality Questionnaire
Personality Traits Description: Personality traits will be assessed using a study-developed self-report questionnaire based on the Five-Factor Model of personality (McCrae \& Costa), assessing Neuroticism, Extraversion, Openness to Experience, Agreeableness, and Conscientiousness. Each domain is assessed using 12 items rated on a 5-point Likert scale (range: 1-5), with higher scores indicating greater expression of the respective personality trait. Time Frame: 3 months only
Time frame: One time ask @ 3 months only
Experience w/Computers
Experience with Computers - Years of Use Experience with computers will be assessed by self-report of the number of years the participant has been using computers (years), with higher values indicating greater experience. Experience with Computers - Weekly Use Experience with computers will be assessed by self-report of the typical number of hours per week the participant uses a computer (hours/week), with higher values indicating greater use.
Time frame: One time ask @ Baseline only
Outcome Measure: Home Environment & Home Environment for Physical Activity
Home Environment for Physical Activity Description: The home environment for physical activity will be assessed using the Home Environment Survey (Gattshall et al.), which evaluates availability and accessibility of physical activity equipment. Items are rated on 4 point Likert-type scale, with higher scores indicating greater support for physical activity in the home. Unit of Measure: score on scale Time Frame: 6 weeks only
Time frame: One time ask @ 6 weeks only
Ecological Momentary Assessment (EMA)
Ecological Momentary Assessment (EMA): EMA smartphone check-ins to capture within-day changes in motivation and feelings toward physical activity behaviors.
Time frame: Participants will complete brief EMA surveys through the Pathverse mobile app for 7 consecutive days at weeks 5, 10, 15, 30, and 45.
System Usability - - Time on Platform
Time on Platform Description: Website usage will be assessed using automatically collected platform analytics, including average time spent on the platform per week and average time spent on module pages per week. Unit of Measure: minutes per week Time Frame: Baseline, 6 weeks, 3 months, 6 months
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months
System Usability - Engagement Breadth
Engagement Breadth Description: Engagement breadth will be assessed using automatically collected platform analytics, defined as the percentage of total available pages accessed. Unit of Measure: percent of pages accessed (%) Time Frame: Baseline, 6 weeks, 3 months, 6 months
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months
System Usability - Engagement Duration
Engagement Duration Description: Engagement duration will be assessed using automatically collected platform analytics, defined as the total number of weeks participants engaged with the online platform. Unit of Measure: weeks Time Frame: Baseline, 6 weeks, 3 months, 6 months
Time frame: Time Frame: Baseline, 6 weeks, 3 months, 6 months
Process Evaluation
Process Evaluation will involve a brief quantitative questionnaire to assess use of the intervention material and overall satisfaction of the study similar to our prior trials. Semi-structured interviews will be used to examine each of the subcomponents described in the first step.
Time frame: Process Evaluation will be completed immediately post-intervention (12 months)
Sandy Courtnall L Project Coordinator/Manager, Behavioural Medicine Lab
CONTACT
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