Cardiovascular RiskNCT07393646
Digital Prevention Program With Telephonic Coaching
A study testing Digital Health Platform and Telephonic Coaching in people with Cardiovascular Risk and Cardiovascular Disease Prevention, run by Vivoptim Solutions at 1 site in France.
Trial summary
This study evaluates a digital health prevention program combining digital tools and structured telephonic coaching to support adult participants in improving health-related behaviors and well-being. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk, Cardiovascular Disease Prevention, Health Behavior Change
- What is being tested?
- Digital Health Platform and Telephonic Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,688 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2018to 27 May 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Voluntary enrollment in the digital prevention program.
- Access to digital devices (computer, tablet, or smartphone) to use the digital platform.
- Consent to participate in the program and allow the use of data for research purposes.
- For the analysis cohort: at least one year of participation in the program.
- Insured people of MGEN health insurance
Who cannot join
- Participants who did not provide consent for the use of their data in research.
- Participants with incomplete baseline cardiovascular risk data.
- Participants who withdrew from the program before one year of participation.
- Participants without follow-up data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of a Digital Health and Telephonic Coaching Program for Health Prevention
This study evaluates a digital health prevention program combining digital tools and structured telephonic coaching to support adult participants in improving health-related behaviors and well-being.
Participants voluntarily enrolled in an ongoing prevention program offering personalized digital content, educational resources, and regular telephone-based support provided by trained professionals. The program aims to promote healthier lifestyles, prevent the development of chronic conditions, and improve overall health outcomes.
The study analyzes data collected from a defined cohort of participants enrolled during a specific period to assess changes in health-related outcomes, engagement, and adherence to the program. The results are intended to contribute to the evidence base for digital and telephonic prevention interventions in real-world settings.
- Conditions
- Cardiovascular Risk, Cardiovascular Disease Prevention, Health Behavior Change, Lifestyle (Sedentary Behavior and Physical Activity), Lifestyle Risk Reduction
- Being tested
- Digital Health Platform, Telephonic Coaching
- Medical subject headings
- Sedentary Behavior, Motor Activity, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health PlatformBehavioural
Customized digital platform providing educational content, tools, and resources to support lifestyle changes and improve cardiovascular risk factors, including diet and physical activity. Participants had access to personalized dashboards and tracking features.
Telephonic CoachingBehavioural
Structured telephonic support provided by trained healthcare professionals. Includes regular calls to provide guidance, monitor progress, support behavior change, and reinforce adherence to healthy lifestyle interventions.
| Study group | Role | What they receive |
|---|---|---|
| Digital and Telephonic Prevention Program | Experimental | Participants received access to a digital prevention platform with personalized content and educational resources. They also received regular structured telephonic support from trained healthcare professionals, including coaching and behavioral guidance to improve lifestyle factors such as physical activity, diet, and cardiovascular risk management. All participants were assigned to this intervention without randomization or control group. Receives: Behavioral: Digital Health Platform; Behavioral: Telephonic Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Cardiovascular Risk Level (GCRL)
The primary outcome is the change in participants' Global Cardiovascular Risk Level (GCRL), assessed on a 3-level scale (1: low, 2: medium, 3: high) at inclusion and at yearly follow-up. Improvement is defined as a decrease by at least one level in GCRL, deterioration as an increase by at least one level in GCRL and stable for a constant GCRL
Measured: 1 year, 2 years or more (from program enrollment)
Secondary outcomes (3)
Physical Activity Level
The proportion of participants meeting recommended physical activity levels, assessed at baseline and yearly follow-up. Changes over time are analyzed to determine behavioral improvements associated with program use.
Measured: 1 year, 2 years or more
Dietary Habits - Mediterranean Diet Adherence
The proportion of participants adhering to a Mediterranean diet, assessed at baseline and yearly follow-up. Changes over time are analyzed to determine behavioral improvements associated with program use.
Measured: 1 year, 2 years or more
Duration of program participation
Measured: 1 year, 2 years and more than 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start13 Jul 2018
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular RiskStudies 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
- 2,688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivoptim Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393646
- Sponsor's protocol ID
- VIVOPTIM-DH-2015
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 11 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Digital Health and Telephonic Coaching Program for Health Prevention
- ClinicalTrials.gov ID
- NCT07393646
- Acronym / sponsor ID
- VIVOPTIM-DH-2015
- Conditions
- Cardiovascular Risk, Cardiovascular Disease Prevention, Health Behavior Change, Lifestyle (Sedentary Behavior and Physical Activity), Lifestyle Risk Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,688 participants (actual)
- Lead sponsor
- Vivoptim SolutionsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 6 Feb 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 study evaluates a digital health prevention program combining digital tools and structured telephonic coaching to support adult participants in improving health-related behaviors and well-being.
Participants voluntarily enrolled in an ongoing prevention program offering personalized digital content, educational resources, and regular telephone-based support provided by trained professionals. The program aims to promote healthier lifestyles, prevent the development of chronic conditions, and improve overall health outcomes.
The study analyzes data collected from a defined cohort of participants enrolled during a specific period to assess changes in health-related outcomes, engagement, and adherence to the program. The results are intended to contribute to the evidence base for digital and telephonic prevention interventions in real-world settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital and Telephonic Prevention Program | Experimental | Behavioral: Digital Health Platform, Behavioral: Telephonic CoachingParticipants received access to a digital prevention platform with personalized content and educational resources. They also received regular structured telephonic support from trained healthcare professionals, including coaching and behavioral guidance to improve lifestyle factors such as physical activity, diet, and cardiovascular risk management. All participants were assigned to this intervention without randomization or control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Voluntary enrollment in the digital prevention program.
- Access to digital devices (computer, tablet, or smartphone) to use the digital platform.
- Consent to participate in the program and allow the use of data for research purposes.
- For the analysis cohort: at least one year of participation in the program.
Key exclusion criteria (4 listed)
- Participants who did not provide consent for the use of their data in research.
- Participants with incomplete baseline cardiovascular risk data.
- Participants who withdrew from the program before one year of participation.
- Participants without follow-up data
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 |
|---|---|---|
| Digital Health PlatformCustomized digital platform providing educational content, tools, and resources to support lifestyle changes and improve cardiovascular risk factors, including diet and physical activity. Participants had access to personalized dashboards and tracking features. | Behavioural | Digital and Telephonic Prevention Program |
| Telephonic CoachingStructured telephonic support provided by trained healthcare professionals. Includes regular calls to provide guidance, monitor progress, support behavior change, and reinforce adherence to healthy lifestyle interventions. | Behavioural | Digital and Telephonic Prevention Program |
Primary outcome
Change in Global Cardiovascular Risk Level (GCRL)
Time frame: 1 year, 2 years or more (from program enrollment)
The primary outcome is the change in participants' Global Cardiovascular Risk Level (GCRL), assessed on a 3-level scale (1: low, 2: medium, 3: high) at inclusion and at yearly follow-up. Improvement is defined as a decrease by at least one level in GCRL, deterioration as an increase by at least one level in GCRL and stable for a constant GCRL
3 secondary outcomes
Physical Activity Level
Time frame: 1 year, 2 years or more
Dietary Habits - Mediterranean Diet Adherence
Time frame: 1 year, 2 years or more
Duration of program participation
Time frame: 1 year, 2 years and more than 2 years
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 11 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 Digital Health Platform and Telephonic Coaching in people with Cardiovascular Risk and Cardiovascular Disease Prevention, run by Vivoptim Solutions at 1 site in France.
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 6 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 11 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 France. 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?
Change in Global Cardiovascular Risk Level (GCRL) (time frame: 1 year, 2 years or more (from program enrollment)). 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 11 Feb 2026.