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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05896852
• Other study ID #: STUDY00004962
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: October 2025

Study information

• Verified date: May 2023
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection
• Metabolic Syndrome

Intervention

Behavioral:
• physical activity
Participants will increase their physical activity through walking.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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