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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome; HIV-1-infection
• Intervention / Treatment: Behavioral: physical activity

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Participants will increase their physical activity over 6 months as tolerated,	Behavioral: physical activity; Participants will increase their physical activity through walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic Parameters (Laboratory Measurement - blood glucose)	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.	6 months
Metabolic Parameters (Laboratory Measurement - lipids)	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.	6 months
Metabolic Parameters (Laboratory Measurement - HBA1c)	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.	6 months
Body Composition (Waist Circumference [cm])	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.	6 months
Body Composition (BMI [kg/m^2])	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 months
Quality of Life (Health-Related Quality of Life (SF-36))	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.	6 months

Collaborators and Investigators

• Sponsor: Georgetown University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: STUDY00004962

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No