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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01AA029546-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in steps per day at 3-month follow up | Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit. | 3 months |
| Change in alcohol drinks consumed per week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael D Stein, MD | Boston University, School of Public Health - Health Law Policy & Management | Principal Investigator |
| Lisa Quintiliani, PhD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University, Department of Medicine, remote research | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39019155 | Derived | Abrantes AM, Ferguson E, Stein MD, Magane KM, Fielman S, Karzhevsky S, Flanagan A, Siebers R, Quintiliani LM. Design and rationale for a randomized clinical trial testing the efficacy of a lifestyle physical activity intervention for people with HIV and engaged in unhealthy drinking. Contemp Clin Trials. 2024 Sep;144:107632. doi: 10.1016/j.cct.2024.107632. Epub 2024 Jul 15. |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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.
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| 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. |
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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.
| baseline |
| Changes in theoretically-relevant psychosocial factors including: negative affect, physical activity self-efficacy, physical activity motivation, alcohol-related problems, and time spent sitting | Assessed via self-report measures. | 3 months |