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Идёт набор NCT06700525

StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time

Без фазы С лечением Sedentary Behaviors Screen Time Physical Activity Glucose Metabolism

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: Non-Sedentary Behavior Habit Formation, Sedentary Screen Time Reduction Smartphone App.
Кому может быть актуально
Состояния в реестре: Sedentary Behaviors, Screen Time, Physical Activity, Glucose Metabolism. Базовые параметры: 23 лет — 64 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
США
Следующий шаг
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Обзор

Our goal in this study is to further refine StandUPTV, an application designed to reduce SST in adults in our first study (ASU IRB # STUDY00012109), for the StandUPTV Habits program. This program aims to establish a non-sedentary habit triggered by an alert from the StandUPTV application after participants engage in approximately 30 minutes of SST in the evening.

Подробное описание

This mobile health (mHealth) pilot study aims to develop and test an intervention designed to maintain reductions in evening sedentary screen time (eSST) over a 12-month period. The study will target a nationally recruited sample of adults at risk for type 2 diabetes and will employ a novel habit formation strategy to address individual barriers to sustained behavior change. As a Phase II pilot study within the ORBIT Model framework, this research seeks to provide critical insights into the relationship between maintained reductions in eSST and metabolic health. The intervention combines theory- and evidence-based approaches, leveraging commercially available screen time monitoring tools to scale the StandUPTV application. This pilot study will lay the groundwork for a subsequent Phase III fully-powered randomized clinical trial, aiming to evaluate the impact of sustained eSST reduction on diabetes and cardiovascular disease risk in a national sample.

Вмешательства

  • Поведенческое Non-Sedentary Behavior Habit Formation
    Action Plans Addition to the StandUPTV platform: The StandUPTV mHealth platform will be used to assess SST and deliver behavior change components. Participants will receive a technology kit including a Fitbit Charge 4+ and Wi-Fi-enabled smart plugs. The Fitbit and smart plugs will need to be used for the entire duration of the study participation. Participants will also be assisted with establishing an action plan for a non-sedentary break from evening sedentary screen time, which will be trigg
  • Поведенческое Sedentary Screen Time Reduction Smartphone App
    The StandUPTV application is used to monitor and reduce sedentary screen time (SST). The StandUPTV app has three components: LOCKOUT: Electronic lockout turns off screens when a predetermined limit is reached (50% of baseline value of weekly sedentary screen time). The app also includes planning tools and personalized strategies to limit SST. TEXT: Push notification prompts provide reminders, coaching, and personalized feedback (up to 2 per day). EARN: Opportunities to earn SST by engaging in MV

Первичные конечные точки

  • Changes in Sedentary Screen Time [Срок оценки: Baseline, 4 months, 12 months]
Вторичные конечные точки (4)
  • Changes in moderate to vigorous physical activity [Срок оценки: Baseline, 4 months, 12 months]
  • Changes in Sleep Quality [Срок оценки: Baseline, 4 months, 12 months]
  • Changes in Glucose Metabolism [Срок оценки: Baseline, 4 months, 12 months]
  • HbA1c Level [Срок оценки: Baseline, 4 months, 12 months]

Критерии участия

Критерии включения

  • Insufficiently active as defined by not meeting current US National Guidelines for Physical Activity of 150 minutes of MVPA/week (Measured by the Stanford
  • Leisure-Time Activity Categorical Item)
  • > 3 hours of SST per day
  • Use Android (8.0+) smartphone (8.0+ represents 95% of Android device coverage per https://apilevels.com/)
  • Have regular broadband internet in their home or an unlimited data plan
  • Able to read/understand English (>5th grade literacy)
  • Willing to download StandUPTV Habits
  • Willing to wear activPAL and CGM device during study assessment periods
  • Willing to have data shared in de-identified form in Dexcom Clarity platform
  • Willing to be randomized to either study condition
  • Not traveling overnight or longer in the next 4 months

Критерии исключения

  • Planned relocation
  • Current smoker
  • Have a major illness (e.g., heart disease, cancer, renal disease) for which MVPA is contraindicated
  • Diagnosed with diabetes or gestational diabetes in the past
  • Currently using a CGM
  • Pregnant
  • Occupation that requires substantial use of personal device for media-related activities (e.g., social media)
  • Drug abuse
  • Serious psychological disorder
  • Not willing to use Fitbit or smart plugs for calculation of sedentary screen time for functionality of StandUPTV app

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Arizona State University — Tempe
  • California Polytechnic University San Luis Obispo — San Luis Obispo

Идентификаторы

NCT: NCT06700525 · STUDY00020613 · 1R01DK135488-01A1

Первоисточники (государственные реестры)

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