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Completed

NCT Number: NCT07393646

Digital Prevention Program With Telephonic Coaching

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.

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Key information

Conditions

Cardiovascular Risk Behavior Cardiovascular Disease Prevention Health Behavior Change Lifestyle (Sedentary Behavior and Physical Activity) Lifestyle Risk Reduction Motor Activity Risk Reduction Behavior Sedentary Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vivoptim Solutions

Paris, 75014, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Digital Health Platform

Behavioral

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 Coaching

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Physical Activity Level

    Time frame: 1 year, 2 years or more

    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.

  2. Dietary Habits - Mediterranean Diet Adherence

    Time frame: 1 year, 2 years or more

    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.

  3. Duration of program participation

    Time frame: 1 year, 2 years and more than 2 years

Sponsors and collaborators

Lead sponsor

Vivoptim Solutions

Industry

Registry information

Official study title

Prospective Evaluation of a Digital Health and Telephonic Coaching Program for Health Prevention

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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