About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 60-70 years
Recently retired (within the past 1.5 years) from occupational work
Access to the internet via computer or smartphone
Able to engage in moderate-to-vigorous physical activity (MVPA) independently
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Self Regulation Digital Health Online Platform
BehavioralThe 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.
Identity Digital Health Online Platform
BehavioralThe 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 Digital Health Online Platform
BehavioralControl 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).
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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
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
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
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