A Multi-Modal Approach to Improving the Early Detection of Cardiometabolic Disease Risk
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Blood lipids
研究概览
简要总结
The goal of this observational study is to reduce an individual's cardiometabolic disease risk by improving the ability to detect cardiometabolic disease risk in young adults through the use of novel technologies that increase access to and examine the utility of, a continuous metabolic syndrome severity score. An additional goal of this study is to understand the barriers to engagement in health-promoting behaviors and beliefs about interventions aimed at mitigating metabolic syndrome risk through a brief online lifestyle intervention.
The main question[s] it aims to answer are:
- Can a smartphone-based imaging system accurately predict a continuous metabolic syndrome severity score, in addition to other markers of cardiometabolic disease, in young adults?
- What is the relationship between autonomic dysfunction and metabolic syndrome severity in a cohort of young adults?
- What is the relationship between peripheral vascular dysfunction and metabolic syndrome severity in a cohort of young adults?
- What are the associations between metabolic syndrome severity and gait and functional ability in young adults using novel markerless motion capture technology?
- What are the attitudes and barriers towards lifestyle interventions targeted to reduce metabolic syndrome severity?
- What are the treatment-seeking and willingness to engage behaviors toward a webpage focused on lifestyle interventions to reduce metabolic syndrome severity?
Participants will be asked to undergo several assessments across four separate days which are design designed to determine the associations between cardiometabolic health markers and components of:
- body composition
- cardiovascular function
- functional ability
- attitudes and behaviors towards health-related interventions
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults between the ages of 18-39 years of age
排除标准
- •Younger than 18 or older than 39
- •Breastfeeding or lactating
- •Missing any limbs or part of a limb
- •Having a substantial amount of metal implants (metal plates or complete joint replacements)
- •Having a pacemaker or any other electrical implant
- •Type I diabetes
- •Gestational diabetes
- •Taking insulin
- •Diagnosed heart failure, cardiomyopathy (dilated or hypertrophic), valvular disease
- •Any history of severe traumatic brain injury or mild traumatic brain injury within the last two years
- •Kidney disease
- •Liver disease
- •Thyroid disease
- •Any diagnosed neurological or neurodegenerative diseases
- •Having received ionizing radiation from a medical procedure within the last 30 days
- •Being on a medically prescribed diet
- •Having donated blood or plasma in the last 20 days prior to blood collection procedures
- •Taking any supplements/medications that may interfere with the results of the study
- •Any injury or physical impairment that would prevent performing any functional measures for this study
结局指标
主要结局
Blood lipids
时间窗: Baseline
Triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol collected from capillary blood
Waist Circumference
时间窗: Baseline
Circumference of the waist measured by tape measure at the level of the iliac crest
Metabolic syndrome severity score
时间窗: Baseline
A race and sex-specific equation that uses systolic blood pressure, waist circumference, and blood lipids to calculate a single continuous score that quantifies a person's overall cardiometabolic disease severity on a continuum where higher scores equal a worse outcome and negative scores equal a better outcome. The scale does not have bound and is infinite in positive and negative directions.
Fat mass
时间窗: Baseline
The weight of fat mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Flow-mediated changes in blood pressure
时间窗: Baseline
Changes in blood pressure during 5 minutes of post-occlusive reactive hyperemia collected via finger photoplethysmography
Flow-mediated changes in vascular conductance
时间窗: Baseline
Changes in vascular conductance during 5 minutes of post-occlusive reactive hyperemia calculated as flow per unit of blood pressure
Blood Pressure
时间窗: Baseline
Resting systolic and diastolic blood pressure
Body circumferences
时间窗: Baseline
Central (trunk) and segmental (arms and legs) circumference estimated using smartphone-based digital imaging
Cardiac Baroreflex Sensitivity
时间窗: Baseline
Measure of parasympathetic and sympathetic regulation collected via one-lead electrocardiogram and finger photoplethysmography
Passive Limb Movement Mediated Changes in Blood Pressure
时间窗: Baseline
Changes in blood pressure during passive limb movement collected via finger photoplethysmography
Metaboreflex Heart Rate Responses
时间窗: Baseline
Changes in heart rate during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via one-lead electrocardiogram
Metaboreflex Cardiac Output Responses
时间窗: Baseline
Changes in cardiac output during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography or duplex Doppler ultrasound
Functional Sympatholysis Blood Flow Responses
时间窗: Baseline
Changes in limb blood flow during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise Collected via finger photoplethysmography
Functional Sympatholysis Blood Pressure Responses
时间窗: Baseline
Changes in blood pressure during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise collected via finger photoplethysmography
Gait velocity
时间窗: Immediately post 6-minute walk test
Self-selected walking velocity over level ground measured with a timing gate system.
Knee joint moment
时间窗: Immediately post 6-minute walk test
Knee moment during level ground walking measured in newton-meters measured with a motion capture system.
Fasting blood glucose
时间窗: Baseline
Blood glucose collected from capillary blood
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
时间窗: Baseline
Equation that estimates insulin resistance from glucose and insulin measurements
Tumor necrosis factor-alpha
时间窗: Baseline
Common biomarker of systemic inflammation collected from intravenous blood
Flow-mediated changes in vascular diameter
时间窗: Baseline
Changes in vascular diameter during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Cold Pressor Test Blood Pressure Responses
时间窗: Baseline
Changes in blood pressure during three minutes of cold-pressor activation collected via finger photoplethysmography
Stride Width
时间窗: Immediately post 6-minute walk test
Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Gait Cadence
时间窗: Immediately post 6-minute walk test
Steps taken per minute measured with a motion capture system.
Heart Rate Variability
时间窗: Baseline
Index of cardiac autonomic control collected via one-lead electrocardiogram
Metaboreflex Vascular Resistance Responses
时间窗: Baseline
Changes in vascular resistance during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) calculated as pressure per unit of flow
Ankle joint angle
时间窗: Immediately post 6-minute walk test
Ankle angle during level ground walking measured in degrees measured with a motion capture system.
Hip joint moment
时间窗: Immediately post 6-minute walk test
Hip moment during level ground walking measured in newton-meters measured with a motion capture system.
Center of pressure - right leg
时间窗: Baseline
Whole body center of pressure displacement
Center of pressure - left leg
时间窗: Baseline
Whole body center of pressure displacement
Center of pressure - bilateral
时间窗: Baseline
Whole body center of pressure displacement
Isometric strength
时间窗: Baseline
Isometric muscle strength of hip flexors and extensors, knee flexors and extensors, and ankle dorsi- and plantar flexors of the right leg
Visceral adipose tissue
时间窗: Baseline
Absolute fat-mass around the visceral organs in kilograms measured using dual-energy x-ray absorptiometry and near-infrared reactance spectroscopy
Subcutaneous adipose tissue
时间窗: Baseline
Absolute fat-mass under the cutaneous layer of the skin in kilograms measured using dual-energy x-ray absorptiometry
Motivation and Attitudes Towards Health
时间窗: Baseline
Motivation and Attitudes Towards Changing Health Scale. Scores range from 5-45, which higher scores indicating higher motivation and more positive attitudes towards changing health behavior
Readiness for Behavior Change
时间窗: Baseline
Readiness for Change Questionnaire. Separate subscales are calculated for each of the 5 stages of change (pre-contemplation, contemplation, preparation, action, maintenance) with higher scores indicating a greater likelihood of an individual being in that stage of change versus another. The 12 items on this scale are scored on a scale of -2 to +2 (-2 = Strongly disagree, -1 Disagree, 0 = Unsure, +1 = Agree, +2 = Strongly Agree).
Flow-mediated changes in blood flow
时间窗: Baseline
Changes in blood flow during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Insulin
时间窗: Baseline
Insulin collected from intravenous blood
Body fat percentage
时间窗: Baseline
The percentage of body fat estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Fat-free mass
时间窗: Baseline
The weight of fat-free mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Flow-mediated changes in vascular resistance
时间窗: Baseline
Changes in vascular resistance during 5 minutes of post-occlusive reactive hyperemia calculated as blood pressure per unit of flow
Flow-mediated changes in skeletal muscle oxygenation
时间窗: Baseline
Changes in skeletal muscle oxygenated/deoxygenated hemoglobin saturation during 5 minutes of post-occlusive reactive hyperemia collected via near-infrared spectroscopy
Passive Limb Movement Mediated Changes in Vascular Diameter
时间窗: Baseline
Changes in vascular diameter during passive limb movement collected via duplex Doppler ultrasound
Passive Limb Movement Mediated Changes in Blood Flow
时间窗: Baseline
Changes in blood flow during passive limb movement collected via duplex Doppler ultrasound
Passive Limb Movement Mediated Changes in Vascular Conductance
时间窗: Baseline
Changes in vascular conductance during passive limb movement calculated as flow per unit of pressure
Passive Limb Movement Mediated Changes in Vascular Resistance
时间窗: Baseline
Changes in vascular resistance during passive limb movement calculated as the pressure per unit of flow
Cold Pressor Test Vascular Conductance Responses
时间窗: Baseline
Changes in vascular conductance during three minutes of cold-pressor activation calculated as flow per unit of pressure
Cold Pressor Test stroke volume Responses
时间窗: Baseline
Changes in stroke volume during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound
Cold Pressor Test Cardiac Output Responses
时间窗: Baseline
Changes in cardiac output during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound
Metaboreflex Blood Pressure Responses
时间窗: Baseline
Changes in blood pressure during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography
Metaboreflex Stroke Volume Responses
时间窗: Baseline
Changes in stroke volume during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography or duplex Doppler ultrasound
Functional Sympatholysis Vascular Conductance Responses
时间窗: Baseline
Changes in vascular conductance during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise calculated as flow per unit of pressure
Ankle joint moment
时间窗: Immediately post 6-minute walk test
Ankle moment during level ground walking measured in newton-meters measured with a motion capture system.
Knee joint angle
时间窗: Immediately post 6-minute walk test
Knee angle during level ground walking measured in degrees measured with a motion capture system.
Sit-to-stand
时间窗: Baseline
Time (seconds) for participant to stand up from chair and sit back down (5 repetitions)
Time Up and Down Stairs
时间窗: Baseline
Time (seconds) for participant to stand ascend and descend a single flight (10 steps) of stairs
Treatment Seeking Behavior
时间窗: Baseline
Whether participant engages with educational webpage about health behavior change. This is a dichotomous yes/no value based on whether someone clicks on the webpage or not.
Passive Limb Movement Mediated Changes in Skeletal Muscle Oxygenation
时间窗: Baseline
Changes in skeletal muscle oxygenation during passive limb movement collected via near-infrared spectroscopy
Carotid-Femoral Pulse Wave Velocity
时间窗: Baseline
Index of arterial stiffness collected during rest collected via applanation tonometry and auscultation based wave analysis
Cold Pressor Test Heart Rate Responses
时间窗: Baseline
Changes in heart rate during three minutes of cold-pressor activation collected via one-lead electrocardiogram
Cold Pressor Test Vascular Resistance Responses
时间窗: Baseline
Changes in vascular resistance during three minutes of cold-pressor activation calculated as pressure per unit of flow
Metaboreflex Vascular Conductance Responses
时间窗: Baseline
Changes in vascular conductance during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) calculated as flow per unit of pressure
Functional Sympatholysis Vascular Resistance Responses
时间窗: Baseline
Changes in vascular resistance during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise Calculated as pressure per unit of flow
Stride Length
时间窗: Immediately post 6-minute walk test
Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Hip joint angle
时间窗: Immediately post 6-minute walk test
Hip angle during level ground walking measured in degrees measured with a motion capture system.
Ground reaction forces
时间窗: Immediately post 6-minute walk test
Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.
Timed-up and go
时间窗: Baseline
Time (seconds) for participant to stand up from chair, walk 3 meters, and return
次要结局
- Height(Baseline)
- Weight(Baseline)