search
Back to results

Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV

Primary Purpose

HIV-1-infection, Metabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical activity
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1-infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥ 18 Persons living with or without HIV Metabolic Syndrome or risk factors for metabolic syndrome with BMI >=30 Able to provide informed consent No physical limitations that prevent walking for more than 10 minutes Can provide evidence of medical clearance by healthcare provider, if required before or during the study Exclusion Criteria: Currently exercising regularly (at least 2x weekly of at least 20minutes of moderate or vigorous activity) Current enrollment in another physician activity and/or dietary clinical trial or on diet/weight-loss program Active plans for bariatric surgery Inability to commit to the intervention schedule Not eligible as per screening form Currently pregnant or planning to become pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention Arm

    Arm Description

    Participants will increase their physical activity over 6 months as tolerated,

    Outcomes

    Primary Outcome Measures

    Acceptability of Study Activities (Recruitment)
    To determine acceptability of study activities investigators will determine overall recruitment and determine percentage of the target recruitment that enrolled in the study at the 6 month study completion point (goal = 90% of our target).
    Acceptability of Study Activities (Attrition)
    Investigators will measure attrition by determination of the number of participants who complete all study visits (measured by total number of participants who complete the baseline, 3-month, and 6-month study visits - goal >75%). These will be assessed at the end of the 6-month study period.
    Adherence to Study Activities of Study Activities
    Investigators will determine adherence to study activities by determination of the completion of study visits, completion of laboratory testing at study visits, and completion of step counting journals. Investigators will assess total number of documented study visits, completion of laboratory testing, and assessment of total number of days steps were entered in step logs. Investigators will assess the total number of visits, laboratory blood draws, and entries in to step log at each visit and determine overall percentage completed.

    Secondary Outcome Measures

    Metabolic Parameters (Laboratory Measurement - blood glucose)
    Laboratory measurements including fasting blood glucose (mg/dL) will be at baseline, 3-month, and 6-month visits. Change (increase/decrease) in the fasting blood glucose measurement will be assessed.
    Metabolic Parameters (Laboratory Measurement - lipids)
    Laboratory measurements including lipids (mg/dL) will be at baseline, 3-month, and 6-month visits. Change (increase/decrease) in the lipid measurements will be assessed.
    Metabolic Parameters (Laboratory Measurement - HBA1c)
    Laboratory measurements including HBA1c (mmol/mol) will be measured at baseline, 3-month, and 6-month visits. Change (increase/decrease) in the HBA1c measurement will be assessed.
    Body Composition (Waist Circumference [cm])
    Body measurement including waist circumference in centimeters will be assessed at baseline, 3-month, and 6-month follow-up visits. Changes (increase/decrease) waist circumference will be assessed.
    Body Composition (BMI [kg/m^2])
    Body measurement including BMI [kg/m^2] will be assessed at baseline, 3-month, and 6-month follow-up visits. Changes (increase/decrease) BMI will be assessed.
    Quality of Life (Health-Related Quality of Life (SF-36))
    Health related quality of life will be assessed using the Health-Related Quality of Life (SF-36) scale. The scale includes eight measures - physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores range from 0 (worst) to 100 (best). Changes will be assessed from baseline to responses at the 6 month follow-up.

    Full Information

    First Posted
    May 11, 2023
    Last Updated
    June 6, 2023
    Sponsor
    Georgetown University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05896852
    Brief Title
    Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
    Official Title
    Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    October 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Georgetown University

    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
    This study is being done to understand how a physical activity walking intervention affects metabolic parameters (i.e., blood sugar, cholesterol, certain body measurements) in people with and without HIV. This study involves a physical activity intervention where participants will progressively increase activity as tolerated over a six month period.
    Detailed Description
    This study is being done to understand how a physical activity walking intervention affects metabolic parameters (i.e., blood sugar, cholesterol, certain body measurements) in people with and without HIV. This study involves a physical activity intervention where participants will progressively increase the total number of daily steps to approximately 10,000 steps/day as tolerated. We will monitor participant steps and physical activity using a physical activity monitor. The study will consist of 5 in-person study visits where participants will complete body measurements, laboratory testing (for metabolic parameters e.g. blood sugar and cholesterol), and a questionnaire.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV-1-infection, Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    N/A all study participants will be included in the intervention arm.
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    Participants will increase their physical activity over 6 months as tolerated,
    Intervention Type
    Behavioral
    Intervention Name(s)
    physical activity
    Intervention Description
    Participants will increase their physical activity through walking.
    Primary Outcome Measure Information:
    Title
    Acceptability of Study Activities (Recruitment)
    Description
    To determine acceptability of study activities investigators will determine overall recruitment and determine percentage of the target recruitment that enrolled in the study at the 6 month study completion point (goal = 90% of our target).
    Time Frame
    6 months
    Title
    Acceptability of Study Activities (Attrition)
    Description
    Investigators will measure attrition by determination of the number of participants who complete all study visits (measured by total number of participants who complete the baseline, 3-month, and 6-month study visits - goal >75%). These will be assessed at the end of the 6-month study period.
    Time Frame
    6 months
    Title
    Adherence to Study Activities of Study Activities
    Description
    Investigators will determine adherence to study activities by determination of the completion of study visits, completion of laboratory testing at study visits, and completion of step counting journals. Investigators will assess total number of documented study visits, completion of laboratory testing, and assessment of total number of days steps were entered in step logs. Investigators will assess the total number of visits, laboratory blood draws, and entries in to step log at each visit and determine overall percentage completed.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Metabolic Parameters (Laboratory Measurement - blood glucose)
    Description
    Laboratory measurements including fasting blood glucose (mg/dL) will be at baseline, 3-month, and 6-month visits. Change (increase/decrease) in the fasting blood glucose measurement will be assessed.
    Time Frame
    6 months
    Title
    Metabolic Parameters (Laboratory Measurement - lipids)
    Description
    Laboratory measurements including lipids (mg/dL) will be at baseline, 3-month, and 6-month visits. Change (increase/decrease) in the lipid measurements will be assessed.
    Time Frame
    6 months
    Title
    Metabolic Parameters (Laboratory Measurement - HBA1c)
    Description
    Laboratory measurements including HBA1c (mmol/mol) will be measured at baseline, 3-month, and 6-month visits. Change (increase/decrease) in the HBA1c measurement will be assessed.
    Time Frame
    6 months
    Title
    Body Composition (Waist Circumference [cm])
    Description
    Body measurement including waist circumference in centimeters will be assessed at baseline, 3-month, and 6-month follow-up visits. Changes (increase/decrease) waist circumference will be assessed.
    Time Frame
    6 months
    Title
    Body Composition (BMI [kg/m^2])
    Description
    Body measurement including BMI [kg/m^2] will be assessed at baseline, 3-month, and 6-month follow-up visits. Changes (increase/decrease) BMI will be assessed.
    Time Frame
    6 months
    Title
    Quality of Life (Health-Related Quality of Life (SF-36))
    Description
    Health related quality of life will be assessed using the Health-Related Quality of Life (SF-36) scale. The scale includes eight measures - physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores range from 0 (worst) to 100 (best). Changes will be assessed from baseline to responses at the 6 month follow-up.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 Persons living with or without HIV Metabolic Syndrome or risk factors for metabolic syndrome with BMI >=30 Able to provide informed consent No physical limitations that prevent walking for more than 10 minutes Can provide evidence of medical clearance by healthcare provider, if required before or during the study Exclusion Criteria: Currently exercising regularly (at least 2x weekly of at least 20minutes of moderate or vigorous activity) Current enrollment in another physician activity and/or dietary clinical trial or on diet/weight-loss program Active plans for bariatric surgery Inability to commit to the intervention schedule Not eligible as per screening form Currently pregnant or planning to become pregnant

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV

    We'll reach out to this number within 24 hrs