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Набор по приглашению NCT06372327

Move Often eVery Day 2.0

Без фазы С лечением Exercise

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: Daily Exercise Snacks.
Кому может быть актуально
Состояния в реестре: Exercise. Базовые параметры: от 30 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of this study is to assess a novel, widely-accessible intervention to both promote active breaks from work and improve cognitive and psychological performances at work in motivationally-accessible bouts. This will be done by interrupting prolonged sitting with 1-4 short (1-4 minutes), moderate-to-vigorous physical activity (MVPA) bouts with no equipment, and simple video-based instructions. The short bouts will be referred to as "exercise snacks." In this proposed exercise snacks intervention, investigators explicitly target a population with sedentary jobs due to the generalizability.

Подробное описание

Participants will answer a short 5-10-minute survey to determine eligibility. Eligible candidates will be invited to attend a 30-minute self-directed orientation session to provide a description of the consent form, study objectives and time commitments, the purpose of randomization, and the importance of completing follow-up assessments regardless of outcome. After the orientation sessions, interested and eligible individuals will be sent the e-consent form.

After participants consent to the study, they will be invited to take the baseline survey, and get assistance with study account set-ups (Garmin, GroupMe). Researchers will handle account set ups. Participants will be asked to download both apps and sign into the apps with the study provided accounts. Many individuals may have GroupMe accounts and will be asked to make a profile for their buddy chat with whatever name they prefer (able to hide their real name if preferred). Baseline measures will last for 2 weeks. And then the 6-week intervention will begin.

All consented participants will receive a 6-week intervention. The study is a 2x2 factorial design with 4 different group. We will be assessing the length of snacktivities (1 minute versus 4 minutes) as well as frequency of snacktivities through the day (1 per day versus 4 per day). Therefore, participants will be randomized into 4 groups: One 1-minute snacktivity per day, four 1-minute snacktivities per day, one 4-minute snacktivity per day, or four 4-minute snacktivities per day.

The intervention will consist of the following empirically supported components shown to promote engagement, adherence, and behavior change:

1. Self-monitoring of activity: Participants will be instructed to timestamp and track their snacktivities each day using their phone. Each participant will receive bracelets (1 or 4) that can used to track progress. For example, participants will be taught how they can move the bracelets from one arm to the other to act as a visual aid of how many snacktivities they have done each day. 2. Nightly reporting: Participants will be sent nightly texts to track progress on snacktivities as well as productivity, alertness, and physical energy. 3. Weekly progress reports and tailored feedback: Each week of completion the participant will get a report of their adherence to the protocol for that week and their goals for next week. Embedded in the progress report will be a link for an interactive action plan survey to plan next week's exercises; the action plan is personalized, and incorporates motivational interviewing and problem-solving strategies. Action planning has high acceptability and is identified as an effective behavioral technique that enhances self-monitoring. 4. Relatable modeling: Social modeling theory supports the use of relatable models representing the learner in behavior change and motivation. Dr. Oppezzo's previous work showed high acceptability when the exercise video models were representative of a diverse -body, -ethnicity, and -aged population. Each snacktivity instructional video will feature diverse models performing the moves in work clothes. 5. Barrier problem solving: At baseline, study team members will work with participants to identify a feasible, safe, and comfortably private workday location for performing the activity breaks. 6. Peer support: participants will be assigned a peer buddy who will act as a health-buddy motivational coach. This person will be in a private group-chat with their designated buddy (another participant) and our study account. The study account will monitor conversation and give motivational prompts, when needed, to boost conversation amongst the 2 buddies.

During the maintenance phase (after the intervention phase and lasting 6 months), participants will take part in booster sessions. The first 2 booster sessions will be completed every month, and the following 2 booster sessions will be completed every 6 weeks, following a scaffolded design to ease participants off of the program.

During the follow-up, investigators will collect behavioral data only via zoom. At the end of the study, we will conduct semi-structured interviews on study experience.

Вмешательства

  • Поведенческое Daily Exercise Snacks
    Participants will be encouraged to break up prolonged sitting at work with brief, high-intensity exercise snacks of varying length / total number depending on condition assignment.

Первичные конечные точки

  • Number of self-reported exercise snack breaks at work at week 7 [Срок оценки: Collected 1 work week at week 7 (the week after the 6 week intervention)]
  • Number of self-reported exercise snack breaks at work at week 18 [Срок оценки: collected 1 work week at week 18 (3 months after the intervention)]
  • Number of self-reported exercise snack breaks at work at week 30 during follow-up [Срок оценки: collected 1 work week at week 30 (6 months after the intervention)]
Вторичные конечные точки (1)
  • Liking of exercise snacks [Срок оценки: at week 7, post test, immediately after 6 weeks of treatment]

Критерии участия

Критерии включения

  • Participants must be 30 years of age or older.
  • English speaking
  • Sedentary job with 90% of the work day sitting
  • Not currently taking regular activity breaks at work

Критерии исключения

  • Yes to any Physical Activity Readiness Questionnaire questions or any condition where increased activity is contraindicated
  • Currently doing another worksite physical activity intervention

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Stanford University School of Medicine — Stanford

Идентификаторы

NCT: NCT06372327 · 73468

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗