HIV-1-infectionNCT05896852
Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
A study testing physical activity in people with HIV-1-infection and Metabolic Syndrome, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Metabolic Syndrome
- What is being tested?
- physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
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.
Read the 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.
- Conditions
- HIV-1-infection, Metabolic Syndrome
- Being tested
- physical activity
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
Participants will increase their physical activity through walking.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will increase their physical activity over 6 months as tolerated, Receives: Behavioral: physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Oct 2023
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896852
- Sponsor's protocol ID
- STUDY00004962
- Status last verified
- Oct 2025
- First submitted
- 11 May 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
- ClinicalTrials.gov ID
- NCT05896852
- Acronym / sponsor ID
- STUDY00004962
- Conditions
- HIV-1-infection, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: physical activityParticipants will increase their physical activity over 6 months as tolerated, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activityParticipants will increase their physical activity through walking. | Behavioural | Intervention Arm |
Primary outcome
Acceptability of Study Activities (Recruitment)
Time frame: 6 months
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)
Time frame: 6 months
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
Time frame: 6 months
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.
6 secondary outcomes
Metabolic Parameters (Laboratory Measurement - blood glucose)
Time frame: 6 months
Metabolic Parameters (Laboratory Measurement - lipids)
Time frame: 6 months
Metabolic Parameters (Laboratory Measurement - HBA1c)
Time frame: 6 months
Body Composition (Waist Circumference [cm])
Time frame: 6 months
Body Composition (BMI [kg/m^2])
Time frame: 6 months
Quality of Life (Health-Related Quality of Life (SF-36))
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity in people with HIV-1-infection and Metabolic Syndrome, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Study Activities (Recruitment) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.