Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
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: Smart Walk, Fitbit.
- Кому может быть актуально
- Состояния в реестре: Physical Activity, Exercise, Heart Diseases, Diabetes Mellitus. Базовые параметры: 24 лет — 65 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 →
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Официальное название
Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
Обзор
The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women.
Подробное описание
This study addresses major public health concerns among African American women: physical inactivity and cardiometabolic disease risk.
African American women experience a high burden of cardiometabolic diseases, including heart disease, obesity, and type 2 diabetes. Regular aerobic physical activity is an established behavior to prevent and treat these conditions. Yet, the many African American women are insufficiently active, with only 27-40% meeting national aerobic physical activity guidelines.
This study will test the efficacy of Smart Walk, a culturally tailored, theory-based smartphone-delivered intervention designed to increase physical activity and improve cardiometabolic disease risk factors among African American women. In a 12-month trial, participants will be randomly assigned to either the Smart Walk intervention or a Fitbit-only comparison arm for an active 4-month intervention period, followed by an 8-month minimal contact follow-up period.
Specific Aims:
1. Test the effects of Smart Walk to increase physical activity and promote adherence to national aerobic physical activity guidelines; compared to Fitbit-only comparison group. 2. Test the effects of Smart Walk to improve cardiometabolic risk factors; compared to Fitbit-only comparison group. 3. Compare cost and cost effectiveness of the two intervention groups from a societal perspective. 4. Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes.
Вмешательства
- Поведенческое Smart Walk
Smart Walk is a culturally tailored, Social Cognitive Theory-based multi-component smartphone delivered physical activity (PA) promotion intervention that delivered through the Smart Walk application, virtual physical activity coaching, and text messages. The Smart Walk smartphone application includes four key features: 1) personal profile pages, 2) culturally relevant multi-media physical activity promotion modules, 3) discussion boards, and 4) physical activity self-monitoring/tracking feature - Поведенческое Fitbit
This intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity.
Первичные конечные точки
- Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
Вторичные конечные точки (12)
- Change in cardiorespiratory fitness from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in aortic pulse wave velocity from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in body weight from baseline to 4- and 12-months. [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in body mass index from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in waste circumference from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in blood pressure (mmHG) from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in interleukin 6 (IL-6) from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in interleukin 10 (IL-10) from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in interleukin 15 (IL-15) from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in fasting blood glucose glucose from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
- Change in serum insulin from baseline to 4- and 12-months [Срок оценки: Assessed at baseline, 4-months, 12-months]
Критерии участия
Критерии включения
- Self-reported African American/Black female
- Aged of 24-65 years
- Insufficiently Active (< 60 minutes of moderate-to-vigorous physical activity per week as measured by Exercise Vital Sign Questionnaire)
- BMI > 25 kg/m2
- English speaking and reading
- Ownership of a smartphone with the ability to download applications (i.e., apps)
- Ownership of a smartphone with the ability to receive text messages
- Willingness to receive a physical activity intervention delivered through their smartphone
- Willingness to include their first name or create an alias to be used on their profile page on the Smart Walk app
Критерии исключения
- Plans to relocate out of Phoenix area in next 12 months
- Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a doctor's note for study participation in provided
- Resting systolic blood pressure greater than 180 mmHG and/or a diastolic blood pressure greater than 120 mmHG , as assessed at baseline or at any other study assessment
- Self-reported participation in another diet or weight loss study at screening
- Pregnant or planning to become pregnant in the next 12 months
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
США · 1 центр
- Arizona State University — Phoenix
Идентификаторы
NCT: NCT06337708 · STUDY00017286 · R01HL168170