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Active, Not Recruiting

NCT Number: NCT05896852

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV-1-infection Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

Participants will increase their physical activity through walking.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. Metabolic Parameters (Laboratory Measurement - blood glucose)

    Time frame: 6 months

    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.

  2. Metabolic Parameters (Laboratory Measurement - lipids)

    Time frame: 6 months

    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.

  3. Metabolic Parameters (Laboratory Measurement - HBA1c)

    Time frame: 6 months

    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.

  4. Body Composition (Waist Circumference [cm])

    Time frame: 6 months

    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.

  5. Body Composition (BMI [kg/m^2])

    Time frame: 6 months

    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.

  6. Quality of Life (Health-Related Quality of Life (SF-36))

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2023
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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