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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
No Placebo-Only Group

Summary

This trial tests if increasing physical activity using a Fitbit can help people with HIV who drink too much. One group gets extra help to be more active, while the other just uses the Fitbit. The goal is to see if being more active can reduce drinking and improve health. Fitbit devices have been widely used in various studies to promote physical activity and have shown effectiveness in increasing activity levels and improving health outcomes.

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in number of alcohol drinks consumed per week
Change in steps per day at 6-month follow up
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for problem drinking often include psychosocial interventions such as Cognitive Behavioral Therapy (CBT), Motivational Enhancement Therapy (MET), and physical activity interventions. CBT helps patients identify and change negative thought patterns and behaviors associated with drinking. MET focuses on enhancing the patient's motivation to change their drinking behavior. Physical activity interventions, like the Lifestyle Physical Activity (LPA) program, aim to integrate regular physical activity into the patient's routine, which can improve overall mental and physical health, reduce stress, and provide a healthy alternative to drinking. These treatments are crucial as they address both the psychological and physical aspects of problem drinking, promoting long-term recovery and improved quality of life.

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor
470 Previous Clinical Trials
9,962,751 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
831 Previous Clinical Trials
1,081,544 Total Patients Enrolled
Michael D Stein, MDPrincipal InvestigatorBoston University, School of Public Health - Health Law Policy & Management
5 Previous Clinical Trials
1,063 Total Patients Enrolled

Media Library

Fitbit Only Clinical Trial Eligibility Overview. Trial Name: NCT05505942 — N/A
HIV/AIDS Research Study Groups: Lifestyle Physical Activity (LPA), Fitbit Only
HIV/AIDS Clinical Trial 2023: Fitbit Only Highlights & Side Effects. Trial Name: NCT05505942 — N/A
Fitbit Only 2023 Treatment Timeline for Medical Study. Trial Name: NCT05505942 — N/A
~146 spots leftby Feb 2026