Reframing Retirement: An Examination of Identity Change and Self-Regulation Approaches to Promote Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- MVPA
研究概览
简要总结
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.
详细描述
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:
- aged between 60 -70 years, living in Victoria, British-Columbia, Canada.
- recently retired (within 1.5 years) from occupational work
- have an internet connection with a computer or smartphone
- able to engage in MVPA independently,
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Participating in less than 150 minutes of MVPA per week, based on:
- •Screening with Godin's Leisure Time Exercise Questionnaire, and Baseline accelerometry as secondary confirmation
排除标准
- •- Participation in 150 minutes or more of MVPA per week, based on questionnaire or accelerometry screening
研究组 & 干预措施
Identity Intervention Condition
The ID condition will be comprised of a 6-week, 10 module format (1-2 modules released per week), covering all reflective, regulatory, and reflexive processes. Modules 8-10 cover behavior change techniques targeting habit and identity that correspond to PA during the transition to retirement.
- Participants will be provided with an accelerometer to wear for a week.
- Participants will then 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 exit interview (at 6-months).
干预措施: Identity Digital Health Online Platform (Behavioral)
Self Regulation Intervention Condition
Self Regulation Intervention Condition will have access to modules 1 through 6 (reflective and regulatory processes). 4 additional modules will be included to ensure equivalence of dose across conditions. & focus on general retirement considerations such as travel, socializing, and financial planning with the same style and formatting as the PA modules.
Participants will be provided with an accelerometer to wear for a week. Participants will complete online survey & attend fitness testing @ the lab. All groups 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).
All participants will be asked to participate in a 6 month exit interview.
干预措施: Self Regulation Digital Health Online Platform (Behavioral)
Control Education Group
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).
干预措施: Control Digital Health Online Platform (Behavioral)
结局指标
主要结局
MVPA
时间窗: From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months )
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.
次要结局
- Secondary Outcome Health-Related Fitness Measure 1 - Body Mass Index (BMI)(At Baseline & 6 Months)
- Secondary Outcome Health-Related Fitness Measure 2 - Waist Circumference(Time Frame: Baseline and 6 months)
- Secondary Outcome Health-Related Fitness Measure 3 - Cardiovascular Fitness(Time Frame: Baseline and 6 months)
- Secondary Outcome Health-Related Fitness Measure 4 - Upper-Body Strength(Time Frame: Baseline and 6 months)
- Secondary Outcome Health-Related Fitness Measure 5 - Lower-Body Strength(Time Frame: Baseline and 6 months)
- Secondary Outcome Health-Related Fitness Measure 6 - Flexibility(Time Frame: Baseline and 6 months)
- Secondary Outcome Measure: Reflective Processes(Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months)
- Secondary Outcome Measure: Regulatory Processes(Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months)
- Secondary Outcome Measure: Reflexive Processes - Habit Automaticity (Self-Report Habit Index - Automaticity Subscale)(Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months)
- Secondary Outcome Measure: Reflexive Processes - Identity(Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months)
- Social Identity & Prior Identity(From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months ))
- Well-being outcomes(From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months))
- Subjective norm - Descriptive(Time Frame: Baseline, 6 weeks, 3 months, 6 months)
- Subjective norm - Injunctive(Time Frame: Baseline, 6 weeks, 3 months, 6 months)
- Relatedness(Time Frame: Baseline, 6 weeks, 3 months, 6 months)
- Ecological Momentary Assessment (EMA)(Participants will complete brief EMA surveys through the Pathverse mobile app for 7 consecutive days at weeks 5, 10, 15, 30, and 45.)
- Perceived mental and physical health(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)
- Personality Questionnaire(One time ask @ 3 months only)
- Experience w/Computers(One time ask @ Baseline only)
- Outcome Measure: Home Environment & Home Environment for Physical Activity(One time ask @ 6 weeks only)
- System Usability - - Time on Platform(Time Frame: Baseline, 6 weeks, 3 months, 6 months)
- System Usability - Engagement Breadth(Time Frame: Baseline, 6 weeks, 3 months, 6 months)
- System Usability - Engagement Duration(Time Frame: Baseline, 6 weeks, 3 months, 6 months)
- Process Evaluation(Process Evaluation will be completed immediately post-intervention (12 months))