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רדאר קליני AI
הניסוי הקליני NCT05505942 עבור HIV (נגיף הכשל החיסוני האנושי), חוסר פעילות גופנית, שימוש בלתי בריא באלכוהול הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
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תצוגת כרטיסים

Physical Activity for PLWH and Unhealthy Drinking

מגייס
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 NCT05505942 הוא מחקר מסוג מתערב עבור HIV (נגיף הכשל החיסוני האנושי), חוסר פעילות גופנית, שימוש בלתי בריא באלכוהול, שנמצא כעת במצב מגייס. המחקר התחיל ב-22 בפברואר 2023 ומתוכנן לכלול 340 משתתפים. המחקר מנוהל על ידי אוניברסיטת בוסטון וצפוי להסתיים ב-1 בפברואר 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-7 במרץ 2025.
סיכום קצר
Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes.

Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm.

Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts.

In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine.

The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues.

Follow-up assessments will take place at 3 and 6 months.

תיאור מפורט

Primary Aims - Physical Activity and Drinking Outcomes

To test the efficacy of a 12-week LPA intervention among low-active, PLWH engaged in unhealthy drinking. Participants will be randomly assigned to either: (a) LPA or (b) Fitbit Only control condition. Relative to Fitbit Only, the investigators hypothesize that:

  1. LPA will demonstrate decreases in unhealthy drinking (i.e., drinks/week) end-of-treatment (EOT) and 3 months later (i.e., 6-month follow-up).
  2. LPA will demonstrate higher objective-determined physical activity engagement (i.e., steps/day) at the EOT and at the 6-month follow-up.

Secondary Aims - Physical and Mental Health Functioning Outcomes Relative to Fitbit Only or LPA will result in decreased negative affect and sedentary behavior (i.e., minutes spent sitting/day), heavy drinking days, alcohol-related problems, and increases in adaptive coping, PA self-efficacy, PA motivation, and physical/mental functioning at EOT and 6-month follow-ups.

Tertiary Aims - Examining Mechanisms

  1. Decreases in negative affect and increases in adaptive coping during the intervention period will mediate the relationship between LPA and drinking outcomes at the 6-month follow-up
  2. Increases in PA self-efficacy and motivation will mediate the effect of LPA on PA engagement
  3. Utilizing Ecological momentary assessment (EMA) and Fitbit data, we hypothesize higher negative affect and urges to drink earlier in the day is more likely to increase the likelihood of engaging in bouts of PA later in the day at EOT, relative to baseline, and among persons randomized to LPA versus Fitbit Only.
כותרת רשמית

Increasing Physical Activity Among Persons Living With HIV Engaged in Unhealthy Drinking

מצבים רפואיים
HIV (נגיף הכשל החיסוני האנושי)חוסר פעילות גופניתשימוש בלתי בריא באלכוהול
מזהי מחקר נוספים
מספר NCT
תחילת המחקר (בפועל)
2023-02-22
עדכון אחרון שפורסם
2025-03-07
סיום המחקר (מוערך)
2026-02
השתתפות (מוערכת)
340
סוג המחקר
מתערב
שלב
לא זמין
סטטוס
מגייס
מילות מפתח
Lifestyle physical activity (LPA)
Fitbit
Telehealth
Unhealthy drinking
Ecological momentary assessment
מטרה ראשית
מניעה
הקצאת טיפול
מחקר אקראי
דגם מתערב
שיוך מקבילי
עיוורון
אין (תווית פתוחה)
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיLifestyle Physical Activity (LPA)
The LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine.
LPA Sessions
A study interventionist will conduct phone/video sessions and provide information regarding the acute and long-term psychological and physical benefits of increasing PA. Participants will be introduced to the concept of utilizing brief bouts of PA as a coping strategy for managing emotions and urges to drink alcohol "in-the-moment". Participants will also be given information on the public health guidelines for PA (and how these translate into step counts) as well as how to determine if their PA is moderate intensity (e.g., measuring heart rate and identifying rate of perceived exertion). Study clinicians will also orient participants to the proper use of the Fitbit activity tracker and tips for self-monitoring step counts with the tracker and on the app and/or website.
משווה פעילFitbit Only
The Fitbit only arm will receive only brief check in phone calls and only related to assisting with any Fitbit functioning issues.
רק פיטביט
Interventionists will provide participants information about the proper use of the Fitbit activity tracker and offer tips for self-monitoring step counts with the tracker and on the app and/or website.
תוצאה ראשית
מדד תוצאהתיאור המדידהטווח זמן
Change in steps per day at 6-month follow up
Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.
6 months
Change in number of alcohol drinks consumed per week
Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.
6 months
תוצאה משנית
מדד תוצאהתיאור המדידהטווח זמן
Change in steps per day at 3-month follow up
Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.
3 months
Change in alcohol drinks consumed per week
Assessed by the Timeline Follow Back (TLBF-30) which is a is a calendar that allows a clinician to obtain an estimate of an individual's daily drinking habits over a given time period.
baseline
Changes in theoretically-relevant psychosocial factors including: negative affect, physical activity self-efficacy, physical activity motivation, alcohol-related problems, and time spent sitting
Assessed via self-report measures.
3 months
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, מבוגר יותר
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
  • Have the ability to confirm HIV diagnosis either through visual evidence of ART medication or medical record
  • Engaged in unhealthy drinking, defined as: >7 drinks for women / > 14 drinks for men per week OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.
  • Have a smartphone
  • Considered low active: 150 minutes or less of average weekly physical activity
  • Lives in the USA
  • Has a U.S. mailing address

  • History of bipolar, schizophrenia, schizoaffective disorder or mania per self report.
  • History of withdrawal-related seizures or delirium tremens per self report.
  • Current non-pharmacological treatment for alcohol use disorder.
  • Unable to provide one or more individuals for follow up contact.
  • Current DSM-5 diagnosis of anorexia or bulimia nervosa per self report.
  • Marked organic impairment according to responses to the diagnostic assessments
  • Physical or medical problems that would not allow safe participation in a program of moderate intensity PA
  • Individual who is unwilling to provide their sex at birth
  • Limited or non-readers
National Institute on Alcohol Abuse and Alcoholism (NIAAA) logoNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
איש קשר מרכזי למחקר
צור קשר: Michael D Stein, MD, 617-358-1956, [email protected]
צור קשר: Kara Magane, MS, 617-358-1369, [email protected]
1 מיקומי המחקר ב-1 מדינות

Massachusetts

Boston University, Department of Medicine, remote research, Boston, Massachusetts, 02118, United States
Kara Magane, MS, צור קשר, 617-358-1369, [email protected]
מגייס