Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07572721

Virtual Lifestyle Intervention for Weight Management and Cardiovascular Heal

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multicomponent Virtual Lifestyle Intervention

Behavioral

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.

Primary outcomes

  1. Body weight

    Time frame: 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
  2. Waist Circumference

    Time frame: 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 outcomes

  1. HbA1c

    Time frame: 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
  2. Lipid Profile

    Time frame: 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
  3. Blood Pressure

    Time frame: 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
  4. Physical fitness

    Time frame: 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)
  5. SF 36

    Time frame: 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
  6. Physical fitness

    Time frame: 90 days

    • 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)
  7. Body Composition

    Time frame: 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
  8. Physical fitness

    Time frame: 90 days

    • 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)
  9. Physical Fitness

    Time frame: 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)

Other outcomes

  1. Wearable Device Behavioral Patterns

    Time frame: 90 days

    • Measure:** Wearable device-derived behavioral patterns and adherence metrics
    • Time Frame:** Throughout 90-day intervention period
    • Description:** Analysis of behavioral pattern of daily step counts active minutes, sleep quality and duration, heart rate variability, and readiness scores collected via compatible wearable devices. This will be used to analyze if there are changes from baseline that occur across 90 day period
  2. Peloton Platform Engagement

    Time frame: 90 days

    • Measure:** Peloton platform engagement patterns
    • Time Frame:** Throughout 90-day intervention period
    • Description:** Analysis of engagement patterns with Peloton platform including class completion rates and exercise intensity data. Users select pre-recorded workouts through the peloton app. Selection and completion of these pre-recorded classes will be analyzed.

Sponsors and collaborators

Lead sponsor

Truemedicine Inc

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.