Virtual Lifestyle Intervention for Weight Management and Cardiovascular Heal

NCT07572721 | Enrolling By Invitation

• 1 other identifier: TRU001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor

Keywords

type 2 diabetes; high cholesterol; obesity; cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• 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

  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

  90 days

Secondary Outcomes (9)

• HbA1c

  90 days

• Lipid Profile

  90 days

• Blood Pressure

  90 days

• Physical fitness

  90 days

• SF 36

  90 days

Other Outcomes (2)

• Wearable Device Behavioral Patterns

  90 days

• Peloton Platform Engagement

  90 days

Study Arms (1)

Multicomponent Lifestyle Intervention

EXPERIMENTAL

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

Interventions

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.

Multicomponent Lifestyle Intervention

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Truemedicine Inc: lead

Study Sites (1)

Alethios

San Francisco, California, 94104, United States

Location

Related Publications (1)

• Available upon request

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypercholesterolemia; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 7, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)