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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
Alethios
San Francisco, California, United States
Body weight
* 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
Time frame: 90 days
Waist Circumference
* 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
Time frame: 90 days
HbA1c
* 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
Time frame: 90 days
Lipid Profile
* 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
Time frame: 90 days
Blood Pressure
* 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
Time frame: 90 days
Physical fitness
* 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 90 days
SF 36
* 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
Time frame: 90 days
Physical fitness
* Measure:\*\* Change in physical fitness outcomes from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) Changes in plank hold duration (seconds)
Time frame: 90 days
Body Composition
* 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
Time frame: 90 days
Physical fitness
* Measure:\*\* Change in physical fitness outcomes from baseline to Day 90 * Time Frame:\*\* Baseline and Day 90 (90 days) Changes in aerobic capacity via 12-minute run/walk test (distance)
Time frame: 90 days
Physical Fitness
* 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)
Time frame: 90 days