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临床试验/NCT07350915
NCT07350915已完成不适用

Randomized Study of Healthy Lifestyle Promotion Using an App Versus Health Education in Sedentary Individuals or Participants in Walking Groups Aged 60 to 80

Politecnico di Milano0 个研究点目标入组 237 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
237

研究概览

简要总结

The objective of WP2 of the Active3 project is to develop a digital solution for promoting and monitoring physical activity in social settings (real or virtual) that implements a Preventive Medicine approach to healthy aging.

Specifically, the objective of the action related to Word Package 2 is to develop a personalized, data-driven coaching platform co-designed with local healthcare services, clinicians, technologists, designers, and management engineers to stimulate and promote an active lifestyle and prevent health risks among the over-60 population in Lecco and its province.

Active Healthy Aging initiatives, such as the Walking Groups coordinated by local healthcare services, are already active in the Lecco area. This personalized coaching platform aims to leverage these initiatives for prevention and treatment purposes. Its objectives are:

  • Creating a user-friendly technological tool for local healthcare services/clinical organizations for projects encouraging physical activity as a driver of lifestyle-based prevention;
  • Test this digital therapeutic practice (with a clinical study) on a cohort of 200 individuals to validate its usability, adherence and preliminary efficacy.

The main questions it aims to answer are:

Will a Digital Therapeutics (DTx) based on Active Lifestyle and balance nutrition promotion be adopted and used in an elderly propulation?

What outcomes in health scores will Active3-WP2 platform achieve in physical, metabolic and cognitive domains?

Researchers will compare the use of the proposed DTxA to a contrl gropu receiving a standard educational program.

Participants will:

  • receive the Active3-WP2 platform (App+ Wearable)
  • participate in health screenings at month 0, month 6 and month 12.

详细描述

The UN has declared the period 2021-2030 the decade of healthy ageing, based on epidemiological data that show a rapid increase in the elderly population not only in developed countries, but also in middle- and low-income countries.

In this context, the demographic evolution of Italian society over the last twenty years, together with the increase in life expectancy obtained thanks to progress in prevention and treatment approaches, makes the share of the over-60 population increasingly relevant. This population group is heterogeneous but has a significant component of individuals still in work or with good personal and social functioning, although often suffering from one or more chronic diseases or presenting risk factors for future acute or chronic pathological events.

Numerous pieces of evidence confirm that the adoption of healthy lifestyles, with regular physical activity and proper nutrition, is able to have a favorable impact in terms of reducing the risk of morbid events in the neurological and cardiovascular fields through the modification of parameters that are related to these risks. Among these, a particularly important role is played by the body mass index and systolic and diastolic blood pressure values, as well as glycemic and lipid control levels.

In addition to physical activity and diet, other parameters such as satisfactory social interaction are also able to positively influence the so-called healthy ageing, with the consequent cost reductions due to the lower incidence and impact of acute and chronic diseases.

Several studies suggest that the active involvement of recipients of interventions aimed at changing lifestyle habits is a key factor in determining the success of such interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged between 60 and 80 years.

排除标准

  • Presence of pathologies, in particular cardio-respiratory diseases, of such severity to prevent the execution of the physical tests and activities promoted by the DTx
  • Inability to consent to participate in research.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Andreoni

Full Professor

Politecnico di Milano

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