Physical Activity for PLWH and Unhealthy Drinking

Not Applicable

Recruiting

• Conditions: Physical Inactivity; HIV; Unhealthy Alcohol Use
• Interventions: Behavioral: LPA Sessions; Other: Fitbit Only

• Registration Number: NCT05505942
• Lead Sponsor: Boston University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Study Start: 2023-02-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• 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: less active than the public health recommendations of 150 minutes per week of moderate intensity PA for the past 3 months
• Lives in the USA
• Has a U.S. mailing address

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Physical Activity (LPA)	LPA Sessions	The LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine.
Fitbit Only	Fitbit Only	The Fitbit only arm will receive only brief check in phone calls and only related to assisting with any Fitbit functioning issues.

Primary Outcome Measures

Name	Time	Method
Change in number of alcohol drinks consumed per week	6 months	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.
Change in steps per day at 6-month follow up	6 months	Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.

Secondary Outcome Measures

Name	Time	Method
Change in steps per day at 3-month follow up	3 months	Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.
Change in alcohol drinks consumed per week	baseline	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.
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	Assessed via self-report measures.

Trial Locations

Locations (1)

Boston University, Department of Medicine, remote research; 🇺🇸 Boston, Massachusetts, United States