Physical Activity for PLWH and Unhealthy Drinking
Primary Purpose
HIV, Physical Inactivity, Unhealthy Alcohol Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LPA Sessions
Fitbit Only
Sponsored by
About this trial
This is an interventional prevention trial for HIV focused on measuring Lifestyle physical activity (LPA), Fitbit, Telehealth, Unhealthy drinking, Ecological momentary assessment
Eligibility Criteria
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
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
Sites / Locations
- Boston University, Department of Medicine, remote researchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lifestyle Physical Activity (LPA)
Fitbit Only
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Change in alcohol drinks consumed per week
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
Assessed via self-report measures.
Full Information
NCT ID
NCT05505942
First Posted
August 16, 2022
Last Updated
August 9, 2023
Sponsor
Boston University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05505942
Brief Title
Physical Activity for PLWH and Unhealthy Drinking
Official Title
Increasing Physical Activity Among Persons Living With HIV Engaged in Unhealthy Drinking
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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).
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
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
Increases in PA self-efficacy and motivation will mediate the effect of LPA on PA engagement
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Physical Inactivity, Unhealthy Alcohol Use
Keywords
Lifestyle physical activity (LPA), Fitbit, Telehealth, Unhealthy drinking, Ecological momentary assessment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Physical Activity (LPA)
Arm Type
Experimental
Arm Description
The LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine.
Arm Title
Fitbit Only
Arm Type
Active Comparator
Arm Description
The Fitbit only arm will receive only brief check in phone calls and only related to assisting with any Fitbit functioning issues.
Intervention Type
Behavioral
Intervention Name(s)
LPA Sessions
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fitbit Only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in steps per day at 6-month follow up
Description
Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.
Time Frame
6 months
Title
Change in number of alcohol drinks consumed per week
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in steps per day at 3-month follow up
Description
Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.
Time Frame
3 months
Title
Change in alcohol drinks consumed per week
Description
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.
Time Frame
baseline
Title
Changes in theoretically-relevant psychosocial factors including: negative affect, physical activity self-efficacy, physical activity motivation, alcohol-related problems, and time spent sitting
Description
Assessed via self-report measures.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael D Stein, MD
Phone
617-358-1956
Email
mdstein@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kara Magane, MS
Phone
617-358-1369
Email
maganek@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Stein, MD
Organizational Affiliation
Boston University, School of Public Health - Health Law Policy & Management
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Quintiliani, PhD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University, Department of Medicine, remote research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Magane, MS
Phone
617-358-1369
Email
maganek@bu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Physical Activity for PLWH and Unhealthy Drinking
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