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Набор скоро начнётся NCT07446231

Reframing Retirement: An Examination of Identity Change and Self-Regulation Approaches to Promote Physical Activity

Без фазы С лечением Physical Activity Health Promotion

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Self Regulation Digital Health Online Platform, Identity Digital Health Online Platform, Control Digital Health Online Platform.
Кому может быть актуально
Состояния в реестре: Physical Activity, Health Promotion. Базовые параметры: 60 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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).

Вмешательства

  • Поведенческое Self Regulation Digital Health Online Platform
    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 Planni
  • Поведенческое Identity Digital Health Online Platform
    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 O
  • Поведенческое Control Digital Health Online Platform
    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 t

Первичные конечные точки

  • MVPA [Срок оценки: From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months )]
Вторичные конечные точки (12)
  • Secondary Outcome Health-Related Fitness Measure 1 - Body Mass Index (BMI) [Срок оценки: At Baseline & 6 Months]
  • Secondary Outcome Health-Related Fitness Measure 2 - Waist Circumference [Срок оценки: Time Frame: Baseline and 6 months]
  • Secondary Outcome Health-Related Fitness Measure 3 - Cardiovascular Fitness [Срок оценки: Time Frame: Baseline and 6 months]
  • Secondary Outcome Health-Related Fitness Measure 4 - Upper-Body Strength [Срок оценки: Time Frame: Baseline and 6 months]
  • Secondary Outcome Health-Related Fitness Measure 5 - Lower-Body Strength [Срок оценки: Time Frame: Baseline and 6 months]
  • Secondary Outcome Health-Related Fitness Measure 6 - Flexibility [Срок оценки: Time Frame: Baseline and 6 months]
  • Secondary Outcome Measure: Reflective Processes [Срок оценки: Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months]
  • Secondary Outcome Measure: Regulatory Processes [Срок оценки: Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months]
  • Secondary Outcome Measure: Reflexive Processes - Habit Automaticity (Self-Report Habit Index - Automaticity Subscale) [Срок оценки: Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months]
  • Secondary Outcome Measure: Reflexive Processes - Identity [Срок оценки: Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months]
  • Social Identity & Prior Identity [Срок оценки: From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months )]
  • Well-being outcomes [Срок оценки: From enrollment to the end of data collection (Baseline, 6 Weeks, 3 Months & 6 Months & 12 months)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

\- Participation in 150 minutes or more of MVPA per week, based on questionnaire or accelerometry screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Канада · 1 центр
  • University of Victoria — Victoria

Идентификаторы

NCT: NCT07446231 · PJT-198005

Первоисточники (государственные реестры)

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