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临床试验/NCT07393646
NCT07393646已完成不适用

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

Vivoptim Solutions1 个研究点 分布在 1 个国家目标入组 2,688 人开始时间: 2018年7月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,688
试验地点
1
主要终点
Change in Global Cardiovascular Risk Level (GCRL)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Digital Health Platform (Behavioral)

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.

干预措施: Telephonic Coaching (Behavioral)

结局指标

主要结局

Change in Global Cardiovascular Risk Level (GCRL)

时间窗: 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

次要结局

  • 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)

研究者

发起方
Vivoptim Solutions
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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