Virtual Lifestyle Intervention for Weight Management and Cardiovascular Heal

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Multicomponent Virtual Lifestyle Intervention

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94104
      • Alethios

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multicomponent Lifestyle Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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)	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	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)	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	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)	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)	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	90 days

Collaborators and Investigators

• Sponsor: Truemedicine Inc

Publications and helpful links

General Publications

• Available upon request

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: obesity; cardiovascular disease; type 2 diabetes; high cholesterol
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Hypercholesterolemia
• Other Study ID Numbers: TRU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No