Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability of Study Activities (Recruitment)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
N/A all study participants will be included in the intervention arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Arm
Participants will increase their physical activity over 6 months as tolerated,
干预措施: physical activity (Behavioral)
结局指标
主要结局
Acceptability of Study Activities (Recruitment)
时间窗: 6 months
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).
Adherence to Study Activities of Study Activities
时间窗: 6 months
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.
Acceptability of Study Activities (Attrition)
时间窗: 6 months
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.
次要结局
- Metabolic Parameters (Laboratory Measurement - HBA1c)(6 months)
- Metabolic Parameters (Laboratory Measurement - blood glucose)(6 months)
- Metabolic Parameters (Laboratory Measurement - lipids)(6 months)
- Body Composition (Waist Circumference [cm])(6 months)
- Body Composition (BMI [kg/m^2])(6 months)
- Quality of Life (Health-Related Quality of Life (SF-36))(6 months)