רדאר קליני AI | ||
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הניסוי הקליני NCT05472402 (LADIES Online) עבור התנהגות יושבנית, Lack of Physical Activity, חוסר פעילות גופנית הוא פעיל, לא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
ניסוי אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women (LADIES Online)
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'קבל הסבר' כדי לצפות ולשוחח על מידע מהניסוי בשפה המועדפת עליך.
הניסוי הקליני NCT05472402 (LADIES Online) הוא מחקר מסוג מתערב עבור התנהגות יושבנית, Lack of Physical Activity, חוסר פעילות גופנית, שנמצא כעת במצב פעיל, לא מגייס. המחקר התחיל ב-22 במאי 2022 ומתוכנן לכלול 60 משתתפים. המחקר מנוהל על ידי Gramercy Research Group וצפוי להסתיים ב-30 בנובמבר 2025. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-19 באפריל 2024.
סיכום קצר
This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation.
תיאור מפורט
Research demonstrates the health-related benefits of participation in daily physical activity (PA), including prevention and treatment of chronic diseases. Despite this knowledge, the majority of US adults, particularly black women, do not achieve recommended levels of PA and, consequently, have higher rates of related chronic disease. An efficacy study led by the proposed Principal Investigator developed and tested an in person, 10-month group-based faith-integrated (FI) or secular (SEC) PA intervention, compared with a self-guided control (SG) for black women. Both FI and SEC were superior to SG for increasing daily steps after 10 months, and FI was superior to SG for increasing daily steps 12 months post intervention. Barriers to program participation noted by participants included childcare and work responsibilities and proximity to the group meeting location. The 2018 PA Guidelines Advisory Committee Scientific Report highlighted the need for effective strategies to promote PA, including internet-delivered interventions which have demonstrated strong evidence for effectiveness at increasing PA levels. Limited data exist regarding the efficacy of internet-delivered interventions in racial/ethnic minority groups. Online delivery of our evidence-based program may increase reach and address known barriers to PA program participation in black women. This project will explore strategies for adapting the program for web-based delivery of the existing curriculum. R21 phase aims are: Aim 1: Solicit input from individuals representative of the population of focus to inform the translation of the FI curriculum for online use; Aim 2: Use the knowledge gathered in Aim 1 to adapt existing FI and SG curricula for online use; Aim 3: Assess acceptability of the online curricula in an advisory group similar to the target population. Investigators will conduct focus groups with black women to understand factors that would influence online delivery of the curriculum. A 12-member advisory group will be convened to assist with developing materials/strategies to adapt the curriculum for online delivery. In an iterative approach where material is tested, refined, and retested until complete, investigators will engage the advisory group in feasibility testing of the online curriculum
כותרת רשמית
Feasibility and Acceptability of an Online Program to Promote Physical Activity Among Black Women
מצבים רפואיים
התנהגות יושבניתLack of Physical Activityחוסר פעילות גופניתמזהי מחקר נוספים
- LADIES Online
- R21AG070657 (מענק/חוזה של NIH בארה"ב)
מספר NCT
תחילת המחקר (בפועל)
2022-05-22
עדכון אחרון שפורסם
2024-04-19
סיום המחקר (מוערך)
2025-11-30
השתתפות (מוערכת)
60
סוג המחקר
מתערב
שלב
לא זמין
סטטוס
פעיל, לא מגייס
מטרה ראשית
אחר
הקצאת טיפול
מחקר אקראי
דגם מתערב
שיוך מקבילי
עיוורון
אין (תווית פתוחה)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיLADIES online intervention (R33 phase) Participants will include 30 women who will be randomized to receive six (6) months of online group-based intervention sessions that teach participants how to increase physical activity levels. | LADIES Online Intervention (R33 Phase) Participants will participate weekly online group sessions over 6 months. Participants will also receive access to written intervention materials, access to an online walking program, and access to weekly podcasts that are aligned with the intervention sessions and that support physical activity lessons with biblical scriptures. |
פלצבו להשוואהLADIES online control (R33 phase) Participants will include 30 women who will be randomized to receive self-guided materials that teach participants how to increase physical activity levels. Placebo comparator participants will receive their materials via the online platform. | LADIES Online Control (R33 Phase) Participants will receive online access to a written self-guided curriculum that is self-paced and teaches participants how to increase physical activity. Participants will be encouraged to complete the self-guided curriculum within 6 months. |
תוצאה ראשית
תוצאה משנית
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Daily step counts | Daily walking over 14 consecutive days | Baseline and immediately post intervention |
Bouts of moderate-to-vigorous physical activity | Daily bouts over 14 consecutive days using a wrist-worn accelerometer | Baseline and immediately post intervention |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Sedentary behavior | Daily bouts over 14 consecutive days using a wrist-worn accelerometer | Baseline and immediately post intervention |
Self-reported physical activity | Participant reported using the 7-item self-administered modifided International Physical Activity Questionnaire | Baseline and immediately post intervention |
Clinical measures | Height, weight, seated blood pressure, waist circumference | Baseline and immediately post intervention |
קריטריוני זכאות
- self-identified female
- black/African American
- > 18 years of age
- self-reported low active (i.e., achieving < 150 minutes per week of moderate-to-vigorous physical activity)
- no physical limitations or medical conditions that would be impacted by physical activity
- own a smartphone or computer with reliable high speed internet access
- able to speak and read English fluently; 8) potentially interested in participating in an online health intervention.
המשתתף האחראי למחקר
Melicia Whitt-Glover, חוקר ראשי, President & CEO, Gramercy Research Group
אין נתוני קשר.
1 מיקומי המחקר ב-1 מדינות
North Carolina
Gramercy Research Group, Knightdale, North Carolina, 27545, United States