An interventional study of Digital Health Platform and Telephonic Coaching in Cardiovascular Risk, Cardiovascular Disease Prevention and Health Behavior Change, sponsored by Vivoptim Solutions. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Vivoptim Solutions · Not applicable, Interventional, and 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.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's enrollment of 2,688 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →This is the only study on the registry with Vivoptim Solutions as lead sponsor.
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Exclusion Criteria:
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.
Behavioral: Digital Health Platform · Behavioral: Telephonic Coaching
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.
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.
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
Time frame: 1 year, 2 years or more (from program enrollment)
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.
Time frame: 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.
Time frame: 1 year, 2 years or more
Duration of program participation
Time frame: 1 year, 2 years and more than 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in May 2024, 70 months.
Of 741 interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 70 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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