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

NCT05896852 | Active Not Recruiting

• 1 other identifier: STUDY00004962
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection; Metabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  6 months

Secondary Outcomes (6)

• Metabolic Parameters (Laboratory Measurement - blood glucose)

  6 months

• Metabolic Parameters (Laboratory Measurement - lipids)

  6 months

• Metabolic Parameters (Laboratory Measurement - HBA1c)

  6 months

• Body Composition (Waist Circumference [cm])

  6 months

• Body Composition (BMI [kg/m^2])

  6 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Behavioral: physical activity

Interventions

physical activity BEHAVIORAL

Participants will increase their physical activity through walking.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University

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

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/A all study participants will be included in the intervention arm.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 9, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)