Physical Activity for PLWH and Unhealthy Drinking

NCT05505942 | Active Not Recruiting

• 2 other identifiers: H-425431P01AA029546-01
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Physical Inactivity; Unhealthy Alcohol Use

Keywords

Lifestyle physical activity (LPA); Fitbit; Telehealth; Unhealthy drinking; Ecological momentary assessment

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Change in steps per day at 3-month follow up

  3 months

• Change in alcohol drinks consumed per week

  baseline

• Changes in theoretically-relevant psychosocial factors including: negative affect, physical activity self-efficacy, physical activity motivation, alcohol-related problems, and time spent sitting

  3 months

Study Arms (2)

Lifestyle Physical Activity (LPA)

EXPERIMENTAL

The LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine.

Behavioral: LPA Sessions

Fitbit Only

ACTIVE COMPARATOR

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

Other: Fitbit Only

Interventions

LPA Sessions BEHAVIORAL

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.

Lifestyle Physical Activity (LPA)

Fitbit Only OTHER

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.

Fitbit Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University, Department of Medicine, remote research

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Michael D Stein, MD

  Boston University, School of Public Health - Health Law Policy & Management

  PRINCIPAL INVESTIGATOR

• Lisa Quintiliani, PhD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization procedures to the two groups will apply sex at birth (male/female) and body mass index (greater than or equal to 30 or less than 30) as blocking variables.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: February 22, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)