رادار التجارب AI | ||
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حالة التجربة السريرية NCT06337708 لـ النشاط البدني، التمرين، أمراض القلب، داء السكري، الخمول البدني هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
جامعة ولاية أريزوناSmart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06337708 مصممة لدراسة وقاية لـالنشاط البدني، التمرين، أمراض القلب، داء السكري، الخمول البدني. إنها تجربة تدخُّلية من المرحلة الثانية وهي قيد التجنيد. بدأت في ٢٩ رمضان ١٤٤٥ هـ مع خطة لتجنيد ٢٤٠ مشاركًا. تقودها جامعة ولاية أريزونا، ومن المتوقع اكتمالها بحلول ٥ ذو القعدة ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٨ ذو القعدة ١٤٤٦ هـ.
الملخص
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.
وصف مفصل
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:
- 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.
- Test the effects of Smart Walk to improve cardiometabolic risk factors; compared to Fitbit-only comparison group.
- Compare cost and cost effectiveness of the two intervention groups from a societal perspective.
- Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes.
العنوان الرسمي
Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
الحالات الطبية
النشاط البدنيالتمرينأمراض القلبداء السكريالخمول البدنيمعرّفات دراسة أخرى
- STUDY00017286
- R01HL168170 (منحة/عقد NIH الأمريكي)
NCT معرّف
تاريخ البدء (فعلي)
2024-04-08
آخر تحديث مُنشور
2025-05-16
تاريخ الاكتمال (المقدر)
2028-03-31
عدد المشاركين المخطط لهم
٢٤٠
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الثانية
الحالة
قيد التجنيد
الكلمات الرئيسية
mHealth
women's health
health equity
African American women
Black women
exercise
physical activity
heart disease
diabetes
women's health
health equity
African American women
Black women
exercise
physical activity
heart disease
diabetes
الغرض الأساسي
وقاية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةSmart Walk Participants will receive a culturally tailored smartphone-delivered physical activity intervention. | 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 that integrates with Fitbit activity monitors for participants to track their daily, weekly, and monthly activity. Virtual physical activity coaches will actively engage and facilitate group-based dialogue among participants on the app discussion boards and provide individualized, one-on-one PA coaching via telephone or commercially available app-based video teleconferencing software (i.e., FaceTime, Zoom, Google hangouts). |
مقارن نشطFitbit Participants will receive a Fitbit Inspire 3 activity monitor. | فيتبيت This intervention group will receive a Fitbit activity monitor and be encouraged to use the commercially available device to increase physical activity. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months | Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity | Assessed at baseline, 4-months, 12-months |
Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months | Assessed by the 7-Day Physical Activity Recall | Assessed at baseline, 4-months, 12-months |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in cardiorespiratory fitness from baseline to 4- and 12-months | A modified Balke treadmill protocol will be used to estimate maximal aerobic capacity (i.e., VO2 peak). | Assessed at baseline, 4-months, 12-months |
Change in aortic pulse wave velocity from baseline to 4- and 12-months | A measure of aortic stiffness and will be assessed using SphygmoCor XCEL system using validated methodology. | Assessed at baseline, 4-months, 12-months |
Change in body weight from baseline to 4- and 12-months. | Measured in kilograms using an electronic scale | Assessed at baseline, 4-months, 12-months |
Change in body mass index from baseline to 4- and 12-months | Calculated using the formula: weight (in kilograms) / height (in meters)squared | Assessed at baseline, 4-months, 12-months |
Change in waste circumference from baseline to 4- and 12-months | Measured in centimeters | Assessed at baseline, 4-months, 12-months |
Change in blood pressure (mmHG) from baseline to 4- and 12-months | Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest | Assessed at baseline, 4-months, 12-months |
Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months | Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast. | Assessed at baseline, 4-months, 12-months |
Change in interleukin 6 (IL-6) from baseline to 4- and 12-months | Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast. | Assessed at baseline, 4-months, 12-months |
Change in interleukin 10 (IL-10) from baseline to 4- and 12-months | Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast. | Assessed at baseline, 4-months, 12-months |
Change in interleukin 15 (IL-15) from baseline to 4- and 12-months | Measured in serum using a commercial multiplex immunoassay platform; blood will be drawn after a 10 hour fast. | Assessed at baseline, 4-months, 12-months |
Change in fasting blood glucose glucose from baseline to 4- and 12-months | Plasma glucose assessed after a 10 hour fasting blood draw. Measured using an automated chemistry analyzer. | Assessed at baseline, 4-months, 12-months |
Change in serum insulin from baseline to 4- and 12-months | Serum insulin collected after a 10 hour fasting blood draw. | Assessed at baseline, 4-months, 12-months |
Change in serum lipids (mg/DL) from baseline to 4- and 12-months | Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed | Assessed at baseline, 4-months, 12-months |
Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months | Assessed by calculating homeostatic model assessment (HOMA) scores as: glucose (mg/dl) x insulin (μU/ml)/405. | Assessed at baseline, 4-months, 12-months |
Change in exercise self-efficacy from baseline to 4- and 12-months | Assessed by the 12-item Exercise Self-Efficacy survey (Sallis et al.1987). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-efficacy. | Assessed at baseline, 4-months, 12-months |
Change in self-regulation for physical activity from baseline to 4- and 12-months | Assessed by the 10- item Self-Regulation Scale from the Health Beliefs Survey (Anderson-Bill 2006). This scale assesses the use of behavioral strategies to incorporate physical activity into daily activities (i.e., take stairs instead of elevator, walking instead of driving when running errands). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-regulation. | Assessed at baseline, 4-months, 12-months |
Change in social support for physical activity from baseline to 4- and 12-months | Assessed by the Social Support for Exercise survey developed by Sallis et al (1987). This scale assesses social support from family support (10-items, with a possible range of scores from 10-50) and friends (8-items, with a possible score range from from 8-40). Higher scores indicate greater levels of social support. | Assessed at baseline, 4-months, 12-months |
Change in outcome expectations for physical activity from baseline to 4- and 12-months | Assessed using the 9-item Outcome Expectation Scale for Exercise scale, developed by Resnick (2000). The range of possible scores for this measure is 1-5, with higher scores indicating more positive expectancies associated with physical activity engagement. | Assessed at baseline, 4-months, 12-months |
Change in behavioral capability for physical activity from baseline to 4- and 12-months | Assessed using a 6-item scale developed by the research team in previous research. The range of possible scores for this measure is 1-6, with higher scores indicating higher levels of behavioral capability of physical activity. | Assessed at baseline, 4-months, 12-months |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
24 Years
الجنس المؤهل
أنثى
يقبل المتطوعين الأصحاء
نعم
- 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 > 30 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
- 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
جامعة ولاية أريزونا84 تجارب سريرية نشطة للاستكشافالمعهد الوطني للقلب والرئة والدم759 تجارب سريرية نشطة للاستكشافجهة اتصال مركزية للدراسة
جهة اتصال: Rodney P Joseph, PhD, 602-496-0772, [email protected]
1 مواقع الدراسة في 1 بلدان
Arizona
Arizona State University, Phoenix, Arizona, 85004, United States
Carina Platte, PhD, جهة اتصال, 602-543-2213, [email protected]
Rodney Joseph, PhD, المحقق الرئيسي
قيد التجنيد