Cardiovascular Risk FactorNCT07572721
Virtual Lifestyle Intervention for Weight Management and Cardiovascular Heal
A study testing Multicomponent Virtual Lifestyle Intervention in people with Cardiovascular Risk Factor, run by Truemedicine Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Multicomponent Virtual Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Multicomponent Virtual Lifestyle Intervention
- Keywords
- type 2 diabetes, high cholesterol, obesity, cardiovascular disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypercholesterolemia, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Virtual Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multicomponent Virtual Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 90 days
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start10 Apr 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Truemedicine Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572721
- Sponsor's protocol ID
- TRU001
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07572721
- Acronym / sponsor ID
- TRU001
- Conditions
- Cardiovascular Risk Factor
- Keywords
- type 2 diabetes, high cholesterol, obesity, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Truemedicine IncUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Lifestyle Intervention | Experimental | Behavioral: Multicomponent Virtual Lifestyle InterventionSingle 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent Virtual Lifestyle InterventionA 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. | Behavioural | Multicomponent Lifestyle Intervention |
Primary outcome
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
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
9 secondary outcomes
HbA1c
Time frame: 90 days
Lipid Profile
Time frame: 90 days
Blood Pressure
Time frame: 90 days
Physical fitness
Time frame: 90 days
SF 36
Time frame: 90 days
Physical fitness
Time frame: 90 days
Body Composition
Time frame: 90 days
Physical fitness
Time frame: 90 days
Physical Fitness
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- BackgroundAvailable upon request
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Virtual Lifestyle Intervention in people with Cardiovascular Risk Factor, run by Truemedicine Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07572721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.