Prospective Evaluation of a Digital Health and Telephonic Coaching Program for Health Prevention
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vivoptim Solutions
- Enrollment
- 2,688
- Locations
- 1
- Primary Endpoint
- Change in Global Cardiovascular Risk Level (GCRL)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Digital Health Platform (Behavioral)
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.
Intervention: Telephonic Coaching (Behavioral)
Outcomes
Primary Outcomes
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
- 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)