What side effects are associated with this type of intervention?

Common treatments for problem drinking, such as brief interventions, cognitive-behavioral therapy (CBT), and physical activity interventions, generally have minimal side effects. Brief interventions and CBT may occasionally cause emotional discomfort as individuals confront their drinking behaviors. Physical activity interventions, like the Lifestyle Physical Activity (LPA) program, are typically safe but can lead to minor musculoskeletal injuries or fatigue, especially if participants are not accustomed to regular exercise. Overall, these treatments are well-tolerated and have a low risk of adverse effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of alcohol use disorder, including naltrexone, acamprosate, and disulfiram. These medications work by reducing cravings, managing withdrawal symptoms, or creating adverse reactions to alcohol consumption. In addition to pharmacotherapy, lifestyle interventions such as physical activity have been studied for their potential benefits in managing problem drinking. Physical activity interventions, like the Lifestyle Physical Activity (LPA) trial, focus on incorporating regular exercise into daily routines to improve overall health and potentially reduce alcohol consumption.

What other types of research exist?

Promising, novel alternatives to Lifestyle Physical Activity for problem drinking patients include: 1) Compulsive Exercise Activity Therapy (LEAP), which addresses compulsive exercise behaviors in patients with co-occurring disorders like anorexia nervosa; 2) Mobile health-delivered components, such as smartphone applications and automated telephone continuing care, which have shown efficacy in supporting recovery from substance use disorders; 3) Structured exercise programs like the Veterans Active Recovery (Go-VAR) program, which combines gym memberships, group exercise sessions, and personal training to reduce substance use and improve physical fitness.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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.

Do I qualify?Apply below to find out

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.