"Cook to Health Study 2 ": Monitoring Wellbeing and Health in the Community (Main Study) (C2H2)

August 7, 2019 updated by: University Hospital, Grenoble

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Main Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coaching procedure
Volunteers will received Updated National Dietary Guidelines about food and physical activity with a one-year follow-up, plus connected coaching.
Other: Coaching procedure

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alternate Healthy Eating Index-2010 (AHEI-2010) score
Time Frame: 1 year
calculated by Food Frequency Questionnaires
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

University Grenoble Alps

Investigators

  • Principal Investigator: Christophe PISON, Pr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC16.283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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