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ENROLLING BY INVITATION

NCT07572721

Virtual Lifestyle Intervention for Weight Management and Cardiovascular Heal

Sponsor: Truemedicine Inc

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

30 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-04-10

Completion Date

2026-10-01

Last Updated

2026-05-07

Healthy Volunteers

Conditions

Cardiovascular Risk Factor

Interventions

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.

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

Locations (1)

Alethios

San Francisco, California, United States