Clinical trial NCT05896852: Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
Official title: Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV-1-infection
Metabolic Syndrome
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acceptability of Study Activities (Recruitment)
timeFrame: 6 months
measure: Acceptability of Study Activities (Attrition)
timeFrame: 6 months
measure: Adherence to Study Activities of Study Activities
timeFrame: 6 months
Secondary outcomes:
measure: Metabolic Parameters (Laboratory Measurement - blood glucose)
timeFrame: 6 months
measure: Metabolic Parameters (Laboratory Measurement - lipids)
timeFrame: 6 months
measure: Metabolic Parameters (Laboratory Measurement - HBA1c)
timeFrame: 6 months
measure: Body Composition (Waist Circumference [cm])
timeFrame: 6 months
measure: Body Composition (BMI [kg/m^2])
timeFrame: 6 months
measure: Quality of Life (Health-Related Quality of Life (SF-36))
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: