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

Georgetown University

Status: Active, not recruiting

Conditions: HIV-1-infection; Metabolic Syndrome

Treatments: Behavioral: physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT05896852

STUDY00004962

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intervention Arm

Experimental group

Description:

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

Treatment:

Behavioral: physical activity