رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT07114900 (PA4HealthRCT) لـ النشاط البدني هي نشط (التجنيد مغلق). 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
Randomized Controlled Physical Activity App Intervention for Black Women (PA4HealthRCT)
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 NCT07114900 (PA4HealthRCT) مصممة لدراسة علاج لـالنشاط البدني. إنها تجربة تدخُّلية من المرحلة الثالثة وهي نشط (التجنيد مغلق). بدأت في ٩ رمضان ١٤٤٦ هـ مع خطة لتجنيد ٥٠ مشاركًا. تقودها جامعة ستوني بروك، ومن المتوقع اكتمالها بحلول ١٥ محرم ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١١ ربيع الأول ١٤٤٧ هـ.
الملخص
The goal of this study is test whether a physical activity app intervention compared to wellness text messaging intervention is more acceptable/engaging among Black women who want to increase their level of physical activity.
وصف مفصل
The goal of this K23 aim is to examine the acceptability and feasibility of the 8-week PA4Health intervention compared to a general wellness text program with 3 assessments (baseline, post-intervention [8 weeks] and 6 months). Participants will complete a single counseling session prior to starting the program. They complete an objective measure of physical activity by wearing an accelerometer for one week at each assessment time point. During the intervention, they will provided with a Fitbit wrist tracker, that will be synchronized to the app, to be worn during the 8-week intervention. Participants will be able to set goals for physical activity as well as monitor their progress toward achieving their goals. Following the trial, they will complete self-reports survey as well as objective measures of physical activity. They will also complete a single qualitative interview to assess their experience with the intervention and to provide feedback for modification.
العنوان الرسمي
Developing a Tailored, Theoretically-Driven Smartphone Physical Activity Intervention for African American Women: RCT
الحالات الطبية
النشاط البدنيمعرّفات دراسة أخرى
- PA4HealthRCT
- PA4Health RCT
- K23MD014164 (منحة/عقد NIH الأمريكي)
- RB2023-00444 (معرف آخر) (Institutional Review Board, Stony Brook University)
NCT معرّف
تاريخ البدء (فعلي)
2025-03-09
آخر تحديث مُنشور
2025-09-03
تاريخ الاكتمال (المقدر)
2026-06-30
عدد المشاركين المخطط لهم
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نوع الدراسة
تدخُّلية
المرحلة
المرحلة الثالثة
الحالة
نشط (التجنيد مغلق)
الكلمات الرئيسية
Physical activity app, Wellness Text messaging, RCT
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةBehavioral: PA4Health app physical activity intervention The arm for the PA4health app intervention consists of six components: 1) Goal setting and monitoring, 2) Tailored motivational messages based on survey data on barriers and facilitators of physical activity, 3) Education, which consists of twenty-two physical activity (PA) related topics, 4) a semi-structured chatroom where 3-5 participants per chatroom interact with one another to receive and provide peer support for PA, 5) Locator, which provides information about community resources (e.g., community parks, museums) based on participant's zip code, and 6) Steps, which allow participant to monitor their daily level of exercise. Participants wear a Fitbit tracker during the program Edit | PA4HEALTH APP Physical Activity Intervention PA4Health app intervention Arm Description: During the app intervention consists of six components: 1) Goal setting and monitoring, 2) Tailored motivational messages based on survey data on barriers and facilitators of physical activity, 3) Education, which consists of twenty-two physical activity (PA) related topics, 4) a semi-structured chatroom where 3-5 participants per chatroom interact with one another to receive and provide peer support for PA, 5) Locator, which provides information about community resources (e.g., community parks, museums) based on participant's zip code, and 6) Steps, which allow participant to monitor their daily level of exercise. Participants wear a Fitbit tracker during the program |
مقارن نشطWellness Text Messaging Participants set goal for PA and are encouraged to monitor their level of physical throughout the program. They receive a daily wellness related message during the program as a contact control. They also wear Fitbit tracker during the program. | Wellness Text Messaging Program Participants set goal for PA and are encouraged to monitor their level of physical throughout the program. They receive a daily wellness related message during the program as a contact control. They also wear Fitbit tracker during the program. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
System Usability Scale (SUS)--app satisfaction | Description: The SUS measures ability of technology software. High levels of usability and acceptability of the app will be determined by a score greater than 70 on the SUS. Information will be used for improvement of the software.
Time Frame: 8 weeks study | End of 8 weeks |
Metada data collected from app system | This information will inform usage of patterns of participants, including how frequently the logged into the app system and the component of the app the more frequently or less frequently Time Frame: 8weeks | 8 weeks |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Accelerometer/actigraph data | Actigraph data will be analyzed to explore potential changes over time objectively collected min/week of MVPA | baseline, 8 weeks, 6-month follow-up |
Physical activity constructs | Assess changes in theoretical related constructs for physical activity, Stages of Change, Self-efficacy for Exercise, Physical Activity Enjoyment. Changes in mean scores from baseline to end intervention (8 weeks) will be assessed. Additionally changes in mean scores for these measures from end of intervention (8 weeks) and 6 month follow-up after controlling for baseline will be be explored. | baseline, 8 weeks, 6-month follow-up |
Fitbit data | Fitbit data will be explored to estimate the effect of the intervention on mean steps/week over time | Participants will wear this device daily during the active phase of the 8-week intervention and also until follow-up/ 6-month follow up |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
أنثى
يقبل المتطوعين الأصحاء
نعم
Eligible participants were:
- ages 18-64,
- Identify as AA and female
- own a smartphone
- be able to provide consent
- not regularly physically active (i.e. less than 90 mins. of MVPA per week,
- medically cleared for PA
- have a valid email address, and 9) no previous engagement in the study.
individuals were excluded if they report
. physical limitations to PA engagement
- significant medical conditions (e.g. heart failure)
- planned surgery in the next 6 months
- pregnant or plan to become pregnant in the next 6 months
الجهة المسؤولة عن الدراسة
Marie Aline Sillice, PHD, المحقق الرئيسي, Assistant Professor, Stony Brook University
لا توجد بيانات اتصال.
1 مواقع الدراسة في 1 بلدان
New York
Stony Brook University, Stony Brook, New York, 11794, United States