An interventional study of Multicomponent Virtual Lifestyle Intervention in Cardiovascular Risk Factor, sponsored by Truemedicine Inc. Enrolling by invitation at 1 site in United States. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Truemedicine Inc · Not applicable, Interventional, and Treatment
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with Truemedicine Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 ≥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 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, 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 drugs or participation in another interventional research study during the study period Pregnant or breastfeeding individuals Individuals unable to provide
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm receiving a 90-day multicomponent lifestyle intervention including structured aerobic exercise via Peloton platform, daily supplementation with Omega-3 (2400 mg/day), Vitamin D3 (4,000 IU/day), Magnesium Malate (440 mg/day), and fiber (6g/day), wearable-based activity and sleep tracking, and structured educational content.
Behavioral: Multicomponent 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.
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)
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
Wearable Device Behavioral Patterns
* 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
Time frame: 90 days
Peloton Platform Engagement
* 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.
Time frame: 90 days
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.