Digital Prevention Program With Telephonic Coaching

February 6, 2026 updated by: Vivoptim Solutions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2688

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Vivoptim Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital and Telephonic Prevention Program
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
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.
Behavioral: Telephonic Coaching
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year, 2 years or more (from program enrollment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year, 2 years or more
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.
1 year, 2 years or more
Duration of program participation
Time Frame: 1 year, 2 years and more than 2 years
1 year, 2 years and more than 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivoptim Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2018

Primary Completion (Actual)

May 27, 2024

Study Completion (Actual)

May 27, 2024

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIVOPTIM-DH-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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