Improving the Early Detection of Cardiometabolic Disease Risk

Study Overview
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Brief Summary
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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

Official Title
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A Multi-Modal Approach to Improving the Early Detection of Cardiometabolic Disease Risk

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Online psychoeducational lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - adults between the ages of 18-39 years of age Exclusion Criteria: Younger than 18 or older than 39 Pregnant 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Young Adults<br>Adults between the ages of 18 and 39 years | Behavioral: Online psychoeducational lifestyle intervention<br>* A webpage-baed intervention focused on lifestyle interventions that aim to reduce metabolic syndrome severity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Resting systolic and diastolic blood pressure | Baseline | 
| Waist Circumference | Circumference of the waist measured by tape measure at the level of the iliac crest | Baseline | 
| Fasting blood glucose | Blood glucose collected from capillary blood | Baseline | 
| Blood lipids | Triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol collected from capillary blood | Baseline | 
| Metabolic syndrome severity score | 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. | Baseline | 
| Insulin | Insulin collected from intravenous blood | Baseline | 
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Equation that estimates insulin resistance from glucose and insulin measurements | Baseline | 
| Tumor necrosis factor-alpha | Common biomarker of systemic inflammation collected from intravenous blood | Baseline | 
| Body fat percentage | The percentage of body fat estimated using smartphone-based digital imaging | Baseline | 
| Fat mass | The weight of fat mass in kilograms estimated using smartphone-based digital imaging | Baseline | 
| Fat-free mass | The weight of fat-free mass in kilograms estimated using smartphone-based digital imaging | Baseline | 
| Body circumferences | Central (trunk) and segmental (arms and legs) circumference estimated using smartphone-based digital imaging | Baseline | 
| Heart Rate Variability | Index of cardiac autonomic control collected via one-lead electrocardiogram | Baseline | 
| Cardiac Baroreflex Sensitivity | Measure of parasympathetic and sympathetic regulation collected via one-lead electrocardiogram and finger photoplethysmography | Baseline | 
| Flow-mediated changes in vascular diameter | Changes in vascular diameter during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound | Baseline | 
| Flow-mediated changes in blood flow | Changes in blood flow during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound | Baseline | 
| Flow-mediated changes in blood pressure | Changes in blood pressure during 5 minutes of post-occlusive reactive hyperemia collected via finger photoplethysmography | Baseline | 
| Flow-mediated changes in vascular conductance | Changes in vascular conductance during 5 minutes of post-occlusive reactive hyperemia calculated as flow per unit of blood pressure | Baseline | 
| Flow-mediated changes in vascular resistance | Changes in vascular resistance during 5 minutes of post-occlusive reactive hyperemia calculated as blood pressure per unit of flow | Baseline | 
| Flow-mediated changes in skeletal muscle oxygenation | Changes in skeletal muscle oxygenated/deoxygenated hemoglobin saturation during 5 minutes of post-occlusive reactive hyperemia collected via near-infrared spectroscopy | Baseline | 
| Passive Limb Movement Mediated Changes in Vascular Diameter | Changes in vascular diameter during passive limb movement collected via duplex Doppler ultrasound | Baseline | 
| Passive Limb Movement Mediated Changes in Blood Flow | Changes in blood flow during passive limb movement collected via duplex Doppler ultrasound | Baseline | 
| Passive Limb Movement Mediated Changes in Blood Pressure | Changes in blood pressure during passive limb movement collected via finger photoplethysmography | Baseline | 
| Passive Limb Movement Mediated Changes in Vascular Conductance | Changes in vascular conductance during passive limb movement calculated as flow per unit of pressure | Baseline | 
| Passive Limb Movement Mediated Changes in Vascular Resistance | Changes in vascular resistance during passive limb movement calculated as the pressure per unit of flow | Baseline | 
| Passive Limb Movement Mediated Changes in Skeletal Muscle Oxygenation | Changes in skeletal muscle oxygenation during passive limb movement collected via near-infrared spectroscopy | Baseline | 
| Carotid-Femoral Pulse Wave Velocity | Index of arterial stiffness collected during rest collected via applanation tonometry and auscultation based wave analysis | Baseline | 
| Cold Pressor Test Blood Pressure Responses | Changes in blood pressure during three minutes of cold-pressor activation collected via finger photoplethysmography | Baseline | 
| Cold Pressor Test Heart Rate Responses | Changes in heart rate during three minutes of cold-pressor activation collected via one-lead electrocardiogram | Baseline | 
| Cold Pressor Test Vascular Conductance Responses | Changes in vascular conductance during three minutes of cold-pressor activation calculated as flow per unit of pressure | Baseline | 
| Cold Pressor Test Vascular Resistance Responses | Changes in vascular resistance during three minutes of cold-pressor activation calculated as pressure per unit of flow | Baseline | 
| Cold Pressor Test stroke volume Responses | Changes in stroke volume during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound | Baseline | 
| Cold Pressor Test Cardiac Output Responses | Changes in cardiac output during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound | Baseline | 
| Metaboreflex Blood Pressure Responses | Changes in blood pressure during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography | Baseline | 
| Metaboreflex Heart Rate Responses | 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 | Baseline | 
| Metaboreflex Vascular Conductance Responses | 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 | Baseline | 
| Metaboreflex Vascular Resistance Responses | 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 | Baseline | 
| Metaboreflex Stroke Volume Responses | 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 | Baseline | 
| Metaboreflex Cardiac Output Responses | 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 | Baseline | 
| Functional Sympatholysis Blood Flow Responses | Changes in limb blood flow during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise Collected via finger photoplethysmography | Baseline | 
| Functional Sympatholysis Vascular Conductance Responses | Changes in vascular conductance during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise calculated as flow per unit of pressure | Baseline | 
| Functional Sympatholysis Vascular Resistance Responses | Changes in vascular resistance during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise Calculated as pressure per unit of flow | Baseline | 
| Functional Sympatholysis Blood Pressure Responses | Changes in blood pressure during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise collected via finger photoplethysmography | Baseline | 
| Gait velocity | Self-selected walking velocity over level ground measured with a timing gate system. | Baseline | 
| Gait velocity | Self-selected walking velocity over level ground measured with a timing gate system. | Immediately post 6-minute walk test | 
| Stride Length | Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system. | Baseline | 
| Stride Length | Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system. | Immediately post 6-minute walk test | 
| Stride Width | Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system. | Baseline | 
| Stride Width | Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system. | Immediately post 6-minute walk test | 
| Gait Cadence | Steps taken per minute measured with a motion capture system. | Baseline | 
| Gait Cadence | Steps taken per minute measured with a motion capture system. | Immediately post 6-minute walk test | 
| Ankle joint angle | Ankle angle during level ground walking measured in degrees measured with a motion capture system. | Baseline | 
| Ankle joint moment | Ankle moment during level ground walking measured in newton-meters measured with a motion capture system. | Baseline | 
| Ankle joint angle | Ankle angle during level ground walking measured in degrees measured with a motion capture system. | Immediately post 6-minute walk test | 
| Ankle joint moment | Ankle moment during level ground walking measured in newton-meters measured with a motion capture system. | Immediately post 6-minute walk test | 
| Knee joint angle | Knee angle during level ground walking measured in degrees measured with a motion capture system. | Baseline | 
| Knee joint moment | Knee moment during level ground walking measured in newton-meters measured with a motion capture system. | Baseline | 
| Knee joint angle | Knee angle during level ground walking measured in degrees measured with a motion capture system. | Immediately post 6-minute walk test | 
| Knee joint moment | Knee moment during level ground walking measured in newton-meters measured with a motion capture system. | Immediately post 6-minute walk test | 
| Hip joint angle | Hip angle during level ground walking measured in degrees measured with a motion capture system. | Baseline | 
| Hip joint moment | Hip moment during level ground walking measured in newton-meters measured with a motion capture system. | Baseline | 
| Hip joint angle | Hip angle during level ground walking measured in degrees measured with a motion capture system. | Immediately post 6-minute walk test | 
| Hip joint moment | Hip moment during level ground walking measured in newton-meters measured with a motion capture system. | Immediately post 6-minute walk test | 
| Ground reaction forces | Three-dimensional ground reaction forces during level ground walking measured with a motion capture system. | Baseline | 
| Ground reaction forces | Three-dimensional ground reaction forces during level ground walking measured with a motion capture system. | Immediately post 6-minute walk test | 
| Center of pressure - right leg | Whole body center of pressure displacement | Baseline | 
| Center of pressure - left leg | Whole body center of pressure displacement | Baseline | 
| Center of pressure - bilateral | Whole body center of pressure displacement | Baseline | 
| Timed-up and go | Time (seconds) for participant to stand up from chair, walk 3 meters, and return | Baseline | 
| Sit-to-stand | Time (seconds) for participant to stand up from chair and sit back down (5 repetitions) | Baseline | 
| Time Up and Down Stairs | Time (seconds) for participant to stand ascend and descend a single flight (10 steps) of stairs | Baseline | 
| Isometric strength | Isometric muscle strength of hip flexors and extensors, knee flexors and extensors, and ankle dorsi- and plantar flexors of the right leg | Baseline | 
| Visceral adipose tissue | Absolute fat-mass around the visceral organs in kilograms measured using dual-energy x-ray absorptiometry. | Baseline | 
| Subcutaneous adipose tissue | Absolute fat-mass under the cutaneous layer of the skin in kilograms measured using dual-energy x-ray absorptiometry | Baseline | 
| Motivation and Attitudes Towards Health | 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 | Baseline | 
| Readiness for Behavior Change | 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). | Baseline | 
| Treatment Seeking Behavior | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | Height collected using a stadiometer | Baseline | 
| Weight | Weight collected using a stadiometer | Baseline |