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

NCT ID: NCT05896852

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-10-31

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.

Conditions

HIV-1-infection; Metabolic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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

Group Type: EXPERIMENTAL

physical activity

Intervention Type: BEHAVIORAL

Participants will increase their physical activity through walking.

Interventions

physical activity

Participants will increase their physical activity through walking.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Georgetown University

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

Countries

United States

Other Identifiers

STUDY00004962

Identifier Type: -

Identifier Source: org_study_id