Digital Prevention Program With Telephonic Coaching

NCT07393646 | Completed

• 1 other identifier: VIVOPTIM-DH-2015
• Study Type: interventional
• Target: 2,688
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  1 year, 2 years or more (from program enrollment)

Secondary Outcomes (3)

• Physical Activity Level

  1 year, 2 years or more

• Dietary Habits - Mediterranean Diet Adherence

  1 year, 2 years or more

• Duration of program participation

  1 year, 2 years and more than 2 years

Study Arms (1)

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.

Behavioral: Digital Health Platform; Behavioral: Telephonic Coaching

Interventions

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.

Digital and Telephonic Prevention Program

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.

Digital and Telephonic Prevention Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivoptim Solutions: lead

Study Sites (1)

Vivoptim Solutions

Paris, 75014, France

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: July 13, 2018
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)