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Lifestyle Physical Activity for HIV/AIDS and Problem Drinking
N/A
Recruiting
Led By Michael D Stein, MD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will evaluate the impact of a home-based lifestyle physical activity intervention on alcohol use disorder among people living with HIV.
Who is the study for?
This trial is for adults in the USA living with HIV and engaging in unhealthy drinking, which means more than 7 drinks per week for women or more than 14 for men. Participants should be less active than recommended (under 150 minutes of moderate exercise weekly), own a smartphone, can prove their HIV status, and have a U.S. mailing address. It's not for those with certain mental health conditions, eating disorders, severe medical issues preventing safe exercise, or those currently treated non-pharmacologically for alcohol use.Check my eligibility
What is being tested?
The study tests two methods to reduce unhealthy drinking among people with HIV through physical activity: one group will get lifestyle physical activity (LPA) sessions plus a Fitbit; the other gets only a Fitbit to track steps. The LPA group receives guidance from an interventionist over seven sessions to integrate LPA into daily life while the other group has check-ins by phone about Fitbit use.See study design
What are the potential side effects?
Since this trial focuses on increasing physical activity using technology like Fitbits and personal coaching sessions rather than medication or invasive procedures, side effects are minimal but may include typical exercise-related discomforts such as muscle soreness or fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in number of alcohol drinks consumed per week
Change in steps per day at 6-month follow up
Secondary outcome measures
Change in alcohol drinks consumed per week
Change in steps per day at 3-month follow up
Changes in theoretically-relevant psychosocial factors including: negative affect, physical activity self-efficacy, physical activity motivation, alcohol-related problems, and time spent sitting
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle Physical Activity (LPA)Experimental Treatment1 Intervention
The LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine.
Group II: Fitbit OnlyActive Control1 Intervention
The Fitbit only arm will receive only brief check in phone calls and only related to assisting with any Fitbit functioning issues.
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Who is running the clinical trial?
Boston UniversityLead Sponsor
454 Previous Clinical Trials
9,941,230 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
802 Previous Clinical Trials
1,365,105 Total Patients Enrolled
4 Trials studying Problem Drinking
2,009 Patients Enrolled for Problem Drinking
Michael D Stein, MDPrincipal InvestigatorBoston University, School of Public Health - Health Law Policy & Management
5 Previous Clinical Trials
1,063 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can show proof of my HIV diagnosis through medication or medical records.I am willing to share my sex assigned at birth.I have been diagnosed with anorexia or bulimia according to DSM-5.I cannot provide a contact for follow-up.I drink more than the recommended weekly or single-occasion limits.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle Physical Activity (LPA)
- Group 2: Fitbit Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment open to recruitment of participants?
"Confirmed. According to clinicaltrials.gov's records, this medical research project is actively seeking volunteers for participation. It was initially posted on February 22nd 2023 and received its latest update two days later. A total of 340 patients are required from a single location."
Answered by AI
What are the primary goals of this trial?
"This clinical trial will evaluate the effectiveness of a pre-specified intervention over six months. The primary outcome is Change in steps per day at 6-month follow up, while secondary outcomes include Change in alcohol drinks consumed per week (assessed by TLBF-30), physical activity self-efficacy, and Alcohol related problems which are both assessed through validated self report measures."
Answered by AI
How many subjects are being monitored for the experiment?
"Affirmative. Clinicaltrials.gov reveals that this medical trial is recruiting patients, having been initially listed on February 22nd 2023 and edited most recently on the 24th of the same month. 340 individuals are required to be enrolled from a single institution."
Answered by AI
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