跳至主要内容
临床试验/NCT03169088
NCT03169088已完成不适用

"Cook to Health 2" : Monitoring Wellbeing and Health in the Community

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年3月1日最近更新:
适应症
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
100
试验地点
2
主要终点
Alternate Healthy Eating Index-2010 (AHEI-2010) score

研究概览

简要总结

Unhealthy lifestyles are major factors contributing to chronic conditions that impose a huge financial burden in EU healthcare systems. Unfortunately, the communication of Public Health failed to influence consumer to change their habits.

In this study, the aim is to evaluate the impact of a regular monitoring during 1 year on wellbeing and dietary habits in healthy volunteers.

This study follows the pilot study "cook to health" and is intended to confirm the results obtained by the tools used in C2H, in a larger population (25-50 years)

详细描述

Today, medicine mainly curative and reactive is primarily interested in sick people. Now, with our aging Western populations, we face a strong increase in chronic diseases incidence / prevalence that have a financial cost that becomes unbearable. Society's resources are being drained by the rising costs of disease management and of incremental improvements to our existing health care system. Immediate action is required to reverse these trends. The paradigm shift would be to move from a reactive to a proactive medicine that promote healthy life style to decrease incidence of chronic conditions through P4 Medecine that is Preventive, Participative, Predicitive and Personnalized.

However, unhealthy lifestyles are major factors contributing to chronic conditions that impose a huge financial burden in EU healthcare systems. Insufficient physical activity, poor diet and obesity are significant risk factors for cancers, cardiovascular, chest, metabolic disorders and leading causes of morbidity and premature mortality. Clinically studies indicate that different conditions can be prevented and sometimes reversed through adaptation of healthy habits. But the communication of Public Health failed to influence consumer to change their habits. Hence, it is recognized as a gold standard that better nutrition and better health will reduce the risk of chronic diseases such as obesity and cardiovascular diseases, which impact heavily on health spending. A report by the French National Assembly estimated the cost of obesity for the health insurance, if we add the daily allowances of sick care costs, between 2 and 6 € billion / year (until 4.6% of current health expenditure). As recently summarized by Caroline K. Kramer I 2015 moderate weight loss is related to favorable clinical outcomes. A weight loss of 7% (modification of lifestyle) reduced diabetes progression (-58%). The data collected addressed to health professionals will also enable better guide diagnostics and more efficient care strategies. Unfortunately free-living individuals are often poor at judging the healthiness of their own diet (choice of meal constituents, cooking methods, and portion sizes pattern of eating). Moreover, there is a lack of awareness of the contextual features influencing eating behavior and even where there is motivation to change, people have difficulty translating good intentions into healthy behaviors. Hence, their day-to-day constraints (lack of time, lack of knowledge, constraining family and cultural habits, personal tastes) make it difficult for them to comply and adopt the nationally recommended healthy lifestyles.

In this study, the volunteers will be followed during one year.

The wellbeing will be followed with :

  • survey like FFQ, IPAQ, SF36, dietary habits.
  • actimetry measurement
  • one year follow-up of weight, waist measurement
  • nutritional biomarkers

研究设计

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

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Main Inclusion Criteria:
  • 25 y ≤ Age ≤50 y
  • Live in a family and be the main person who prepares meals
  • Be able to use the personal health monitoring devices;
  • Consenting adults based in Grenoble area France
  • have a valid Internet connection with access from home;
  • Be legally able to give consent.
  • Person affiliated to social security

排除标准

  • Be under chronic use of medications; (except contraception or chronic treatment for headache)
  • Vital prognosis engaged within 12 months;
  • Recent surgical intervention or hospitalization (< 6 months)
  • Being unable to understand, follow objectives and methods due to cognition or language problems;
  • Be likely to move away from the geographic inclusion zone (mainland France);
  • Be unavailable (e.g. work commitment abroad) for the two months following inclusion;
  • Pregnant women, feeding and parturient
  • Playing sports at a high level (more than 7h/week our 1h/day)
  • Subject under administrative or judicial control, person who are protected under the act.
  • Daily alcohol consumption >20g for women and > 30g for men

研究组 & 干预措施

Coaching procedure

Experimental

Volunteers will received Updated National Dietary Guidelines about food and physical activity with a one-year follow-up, plus connected coaching.

干预措施: Coaching procedure (Other)

结局指标

主要结局

Alternate Healthy Eating Index-2010 (AHEI-2010) score

时间窗: 1 year

calculated by Food Frequency Questionnaires

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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