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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 200
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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