Cardiovascular Risk Factor
Conditions
Keywords
type 2 diabetes, high cholesterol, obesity, cardiovascular disease
Brief summary
This is a 90-day, single-arm, open-label, fully virtual community lifestyle intervention study evaluating the effects of a multicomponent lifestyle intervention on weight management and cardiovascular health. Participants will engage in structured aerobic exercise via the Peloton platform, take daily supplements (Omega-3, Vitamin D3, Magnesium Malate, and fiber), use wearable devices for activity and sleep tracking, and receive structured educational content. The study is conducted entirely remotely using the Alethios digital research platform.
Detailed description
This study aims to evaluate the effectiveness of a comprehensive virtual lifestyle intervention program on body weight, waist circumference, and cardiovascular health markers in sedentary adults aged 30-60 years with cardiovascular risk factors. The intervention combines multiple evidence-based components including structured exercise through Peloton, targeted supplementation, wearable-based monitoring, and educational content delivery. Primary outcomes include changes in body weight and waist circumference measured at baseline and day 90. Secondary outcomes include cardiovascular biomarkers measured through dried blood spot sampling, quality of life assessments, body composition metrics, and physical fitness measurements. Exploratory endpoints examine behavioral patterns and adherence metrics from wearable devices and exercise platform engagement data.
Interventions
BEHAVIORALMulticomponent Virtual Lifestyle Intervention
A comprehensive 90-day lifestyle intervention delivered entirely through digital platforms, combining: (1) Structured aerobic exercise via Peloton digital platform with personalized workout recommendations; (2) Daily dietary supplementation including Omega-3 fatty acids (2400 mg/day), Vitamin D3 (4,000 IU/day), Magnesium Malate (440 mg/day), and fiber supplement (6g/day); (3) Continuous monitoring via compatible wearable devices tracking activity, sleep, and physiological metrics; (4) Structured educational content delivered through the Alethios digital research platform covering topics related to nutrition, exercise, and lifestyle optimization.
Sponsors
Truemedicine Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 30 to 60 years at the time of enrollment Stable body weight, defined as no change of more than 5 pounds (2.3 kg) in the three months prior to enrollment Sedentary lifestyle, defined as fewer than 60 minutes of structured exercise per week Not currently participating in any formal weight loss or weight management program Current owner of at least one compatible wearable fitness or health tracking device (Garmin, Fitbit, Apple Watch, Oura Ring, or Whoop) Access to Peloton equipment or willingness to obtain a Peloton digital membership for the duration of the study Must meet the cardiovascular risk profile threshold (minimum of three of five criteria: waist circumference ≥35 inches (women) or ≥40 inches (men), most recent systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, most recent fasting glucose ≥100 mg/dL or HbA1c ≥5.7%, most recent triglycerides ≥150 mg/dL, most recent HDL cholesterol \<40 mg/dL (men) or \<50 mg/dL (women)) Able to read and understand English Willing to provide informed consent electronically Willing and able to complete all digital study activities, surveys, and assessments using the Alethios platform Willing and able to collect at-home dried blood spot (DBS) samples using a provided kit at three designated timepoints
Exclusion criteria
Diagnosis of type 2 diabetes requiring pharmacological management where participation in unsupervised exercise would pose risk, as determined by the investigator Untreated, clinically significant sleep apnea where unsupervised aerobic exercise participation could pose risk Any medical condition or circumstance that, in the opinion of the investigator, would make participation unsafe or interfere with data quality Unwillingness to use Peloton equipment or obtain a Peloton digital membership Current use of investigational drugs or participation in another interventional research study during the study period Pregnant or breastfeeding individuals Individuals unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 90 days | * Measure:\*\* Change in body weight from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) * Description:\*\* Change in body weight measured in kilograms or pounds using self-administered measurements following standardized protocols provided to participants |
| Waist Circumference | 90 days | * Measure:\*\* Change in waist circumference from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) * Description:\*\* Change in waist circumference measured in centimeters or inches using self-administered measurements following standardized protocols provided to participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 90 days | * Measure:\*\* Change in HbA1c from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) * Description:\*\* Change in glycated hemoglobin (HbA1c) measured via dried blood spot (DBS) sampling |
| Lipid Profile | 90 days | * Measure:\*\* Change in lipid profile components from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) * Description:\*\* Changes in triglycerides, HDL cholesterol, and LDL cholesterol measured via dried blood spot (DBS) sampling |
| Blood Pressure | 90 days | * Measure:\*\* Change in self-reported blood pressure from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) * Description:\*\* Changes in systolic and diastolic blood pressure measured via self-reported measurements |
| Physical fitness | 90 days | * Measure:\*\* Change in physical fitness outcomes from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) Changes in sit-to-stand performance (count) |
| SF 36 | 90 days | * Measure:\*\* Change in SF-36 health-related quality of life scores from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) * Description:\*\* Changes in Short Form 36 (SF-36) questionnaire subscale and summary scores assessing health-related quality of life |
| Body Composition | 90 days | * Measure:\*\* Change in body composition metrics from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) * Description:\*\* Changes in body fat percentage using self-administered measurements following standardized protocols |
| Physical Fitness | 90 days | * Measure:\*\* Change in physical fitness outcomes from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) * Description:\*\* Changes in push-up capacity (count) |
Countries
United States
Outcome results
None listed