Cardiovascular Disease Risk FactorNCT07001774
Vitalis Cardio Pilot
A study testing Vitalis Cardio in people with Cardiovascular Disease Risk Factor, run by Lucas Carr at 1 site in United States.
Trial summary
The objective of this study was to evaluate the efficacy and feasibility of a 12-week behavioral counseling intervention that has been integrated into the primary care setting on psychosocial, behavioral, and health outcomes in a large sample of adults with at least one CVD risk factor. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease Risk Factor
- What is being tested?
- Vitalis Cardio
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to 11 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female adults between 18 and 80 years old
- Report at least one known cardiovascular disease risk factor (high blood pressure (systolic > 130 or diastolic > 80), high low-density lipoprotein cholesterol (>160), diabetes diagnosis, smoking, obesity (BMI>30.0), or physical inactivity (<150 minutes/week of moderate intensity physical activity)
- Physically able to become more active
- Own a smartphone with a data plan
- Able to understand English and provide informed consent Report intentions to improve either physical activity, eating, or sleep behaviors Requesting a health coach
Who cannot join
- • Unable to become more active
- Does not own a smartphone with a data plan
- Inability to read, complete or sign the consent form and survey
- Presence of a psychiatric disorder that is not managed/unstable or suicidal ideation/actuation in preceding 12 months Pregnant or plan to become pregnant in the next 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitalis Cardio Pilot Study: A Single Arm Efficacy Study of a Clinical Health Coaching Model
The objective of this study was to evaluate the efficacy and feasibility of a 12-week behavioral counseling intervention that has been integrated into the primary care setting on psychosocial, behavioral, and health outcomes in a large sample of adults with at least one CVD risk factor.
Aim 1: Evaluate the efficacy of a 12-week behavioral counseling intervention on psychosocial outcomes of adults with at least one CVD risk factor.
Read more
H1: We hypothesize participants will improve their behavioral regulation skills and habit formation skills over 12 weeks.
Aim 2: Evaluate the efficacy of a 12-week behavioral counseling intervention on behavioral outcomes (physical activity, diet, and sleep) of adults with at least one CVD risk factor.
H2: We hypothesize participants will improve PA (daily steps), diet (total daily kilocalories), and sleep (sleep time, sleep efficiency) over the 12-week intervention.
Aim 3: Evaluate the efficacy of a 12-week behavioral counseling intervention on health outcomes (blood pressure, weight, waist circumference, body composition, quality of life) of adults with at least one CVD risk factor.
H3: We hypothesize participants will improve blood pressure, weight, waist circumference, body composition, quality of life over the 12-week intervention.
Read the detailed description
The U.S. Preventive Services Task Force (USPSTF) issued a Grade B level recommendation (moderate net benefit) that healthcare providers offer PA and dietary behavioral counseling interventions to adults with known CVD risk factors. Unfortunately, these types of programs are rarely implemented in the healthcare setting. Consistent with the USPSTF recommendations, the American College of Sports Medicine's Exercise is Medicine (EIM) initiative has called for PA to be integrated into healthcare by screening all patients for inactivity and providing inactive patients with behavioral counseling resources. Our team has established an evidence-based EIM program that screens patients for inactivity and connects them to a behavioral counseling program. In November 2018, Family Medicine well-visit patients started receiving screening for inactivity using the two-item Exercise Vital Sign (EVS) questionnaire. In 2021, the first Health Coaching training program was developed in the state of Iowa that is recognized by the National Board for Health and Wellness Coaching (NBHWC). In June 2023, a new clinical workflow was launched in the university electronic medical record system (Epic) which streamlines the process of connecting inactive Family Medicine patients with local health coaches.
This study will test the efficacy of a behavioral counseling program on targeted health behaviors and cardiometabolic risk factors among a sample of adults who are at increased risk for cardiovascular disease.
Patients being treated in the Family Medicine clinic who report wanting to meet with a health coach will be provided a link to an online Health Coach Request form in their After Visit Summary report and MyChart accounts. Patients who choose to open and complete the online Health Coach Request form provide their contact information in the form. Interested patients will be contacted via email to gauge their interest and eligibility. Eligible patients will be enrolled into a 12 week intervention that includes meeting with a student health coach 5 times over 12 weeks, wearing an activity monitor daily, and watching two health education videos.
Aim 1: Evaluate the efficacy of a 12-week behavioral counseling intervention on psychosocial outcomes of adults with at least one CVD risk factor.
Aim 2: Evaluate the efficacy of a 12-week behavioral counseling intervention on behavioral outcomes (physical activity, diet, and sleep) of adults with at least one CVD risk factor.
Aim 3: Evaluate the efficacy of a 12-week behavioral counseling intervention on health outcomes (blood pressure, weight, waist circumference, body composition, quality of life) of adults with at least one CVD risk factor.
- Conditions
- Cardiovascular Disease Risk Factor
- Being tested
- Vitalis Cardio
- Keywords
- health coaching, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitalis CardioBehavioural
Participants receive five free health coaching sessions with a trained student health coach, access to two health education videos, and a free wrist worn activity monitor to keep track of their physical activity and sleep behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Vitalis Cardio Intervention | Experimental | The intervention includes health coaching, health education, and wearable activity monitoring. Receives: Behavioral: Vitalis Cardio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Regulation Skills
Participant's perceived ability to regulate their physical activity, diet, and sleep behaviors using a six item survey that uses a 5 point Likert scale. Scores will range from 6 (low skills) to 30 (high skills).
Measured: From enrollment to 12 weeks
Habit formation skills
Habit formation will be measured with a 3 question survey using a 5 point likert scale. Responses will range from 3 (weak habit) to 15 (strong habit).
Measured: From enrollment to 12 weeks
Secondary outcomes (5)
Physical activity
Daily steps will be measured for 7 days with a Fitbit activity monitor
Measured: From enrollment to 12 weeks
Diet behavior
Measured with the Automated Self-Administered Dietary Assessment (ASA2$) Tool
Measured: From enrollment to 12 weeks
Sleep behavior
Sleep time and sleep efficiency will be measured for 7 days with a Fitbit activity monitor
Measured: From enrollment to 12 weeks
Global Health
Measured with two questions on a 5 point likert scale. Scores will range from 2 (poor) to 10 (excellent)
Measured: From enrollment to 12 weeks
Weight (lbs)
Weight will be measured to the nearest 0.5 lb with a medical scale
Measured: From enrollment to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start19 Sep 2023
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucas Carr
- Sponsor type
- University, hospital or other
- Collaborators
- Google LLC.
- Responsible party
- Sponsor-investigator, Lucas Carr, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001774
- Sponsor's protocol ID
- 202308018
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitalis Cardio Pilot Study: A Single Arm Efficacy Study of a Clinical Health Coaching Model
- ClinicalTrials.gov ID
- NCT07001774
- Acronym / sponsor ID
- 202308018
- Conditions
- Cardiovascular Disease Risk Factor
- Keywords
- health coaching, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lucas CarrUniversity, hospital or other
- Collaborators
- Google LLC.
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 3 Jun 2025 (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.
The objective of this study was to evaluate the efficacy and feasibility of a 12-week behavioral counseling intervention that has been integrated into the primary care setting on psychosocial, behavioral, and health outcomes in a large sample of adults with at least one CVD risk factor.
Aim 1: Evaluate the efficacy of a 12-week behavioral counseling intervention on psychosocial outcomes of adults with at least one CVD risk factor.
H1: We hypothesize participants will improve their behavioral regulation skills and habit formation skills over 12 weeks.
Aim 2: Evaluate the efficacy of a 12-week behavioral counseling intervention on behavioral outcomes (physical activity, diet, and sleep) of adults with at least one CVD risk factor.
H2: We hypothesize participants will improve PA (daily steps), diet (total daily kilocalories), and sleep (sleep time, sleep efficiency) over the 12-week intervention.
Aim 3: Evaluate the efficacy of a 12-week behavioral counseling intervention on health outcomes (blood pressure, weight, waist circumference, body composition, quality of life) of adults with at least one CVD risk factor.
H3: We hypothesize participants will improve blood pressure, weight, waist circumference, body composition, quality of life over the 12-week intervention.
Detailed description
The U.S. Preventive Services Task Force (USPSTF) issued a Grade B level recommendation (moderate net benefit) that healthcare providers offer PA and dietary behavioral counseling interventions to adults with known CVD risk factors. Unfortunately, these types of programs are rarely implemented in the healthcare setting. Consistent with the USPSTF recommendations, the American College of Sports Medicine's Exercise is Medicine (EIM) initiative has called for PA to be integrated into healthcare by screening all patients for inactivity and providing inactive patients with behavioral counseling resources. Our team has established an evidence-based EIM program that screens patients for inactivity and connects them to a behavioral counseling program. In November 2018, Family Medicine well-visit patients started receiving screening for inactivity using the two-item Exercise Vital Sign (EVS) questionnaire. In 2021, the first Health Coaching training program was developed in the state of Iowa that is recognized by the National Board for Health and Wellness Coaching (NBHWC). In June 2023, a new clinical workflow was launched in the university electronic medical record system (Epic) which streamlines the process of connecting inactive Family Medicine patients with local health coaches.
This study will test the efficacy of a behavioral counseling program on targeted health behaviors and cardiometabolic risk factors among a sample of adults who are at increased risk for cardiovascular disease.
Patients being treated in the Family Medicine clinic who report wanting to meet with a health coach will be provided a link to an online Health Coach Request form in their After Visit Summary report and MyChart accounts. Patients who choose to open and complete the online Health Coach Request form provide their contact information in the form. Interested patients will be contacted via email to gauge their interest and eligibility. Eligible patients will be enrolled into a 12 week intervention that includes meeting with a student health coach 5 times over 12 weeks, wearing an activity monitor daily, and watching two health education videos.
Aim 1: Evaluate the efficacy of a 12-week behavioral counseling intervention on psychosocial outcomes of adults with at least one CVD risk factor.
Aim 2: Evaluate the efficacy of a 12-week behavioral counseling intervention on behavioral outcomes (physical activity, diet, and sleep) of adults with at least one CVD risk factor.
Aim 3: Evaluate the efficacy of a 12-week behavioral counseling intervention on health outcomes (blood pressure, weight, waist circumference, body composition, quality of life) of adults with at least one CVD risk factor.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitalis Cardio Intervention | Experimental | Behavioral: Vitalis CardioThe intervention includes health coaching, health education, and wearable activity monitoring. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female adults between 18 and 80 years old
Key exclusion criteria (4 listed)
- • Unable to become more active
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 |
|---|---|---|
| Vitalis CardioParticipants receive five free health coaching sessions with a trained student health coach, access to two health education videos, and a free wrist worn activity monitor to keep track of their physical activity and sleep behaviors. | Behavioural | Vitalis Cardio Intervention |
Primary outcome
Behavioral Regulation Skills
Time frame: From enrollment to 12 weeks
Participant's perceived ability to regulate their physical activity, diet, and sleep behaviors using a six item survey that uses a 5 point Likert scale. Scores will range from 6 (low skills) to 30 (high skills).
Habit formation skills
Time frame: From enrollment to 12 weeks
Habit formation will be measured with a 3 question survey using a 5 point likert scale. Responses will range from 3 (weak habit) to 15 (strong habit).
5 secondary outcomes
Physical activity
Time frame: From enrollment to 12 weeks
Diet behavior
Time frame: From enrollment to 12 weeks
Sleep behavior
Time frame: From enrollment to 12 weeks
Global Health
Time frame: From enrollment to 12 weeks
Weight (lbs)
Time frame: From enrollment to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- 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. This study is not recruiting at the moment.
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 Vitalis Cardio in people with Cardiovascular Disease Risk Factor, run by Lucas Carr 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 12 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavioral Regulation Skills (time frame: From enrollment to 12 weeks). 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?
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 12 Feb 2026.