- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03171571
Personal Lifestyle Assistant for Better Health Through Nutrition (C2H)
Personal Lifestyle Assistant for Better Health Through Nutrition : Cook to Health Study
Study Overview
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 Medicine that is Preventive, Participative, Predictive 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, SF36, dietary habits.
- actimetry measurement
- one year follow-up of weight, waist measurement
- nutritional biomarkers
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Grenoble, France, 38043
- Universiy Hospital Grenoble
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consenting adults based in Grenoble area France without known chronic medications (except contraception) or recent surgical intervention or hospitalization (< 6 months);
- Be able to understand and follow the protocol and use the personal health monitoring devices;
- Be the owner of a electronic tablet (iOS or Android platform) and have a valid Internet connection with access from home;
- Be able to understand the study, its aim and methodology
- Be legally able to give consent.
- 25 < BMI < 29
- 35 y <Age < 45 y
- Live as a couple and and be the main person who prepares meals
Exclusion Criteria:
Vital prognosis engaged within 6 months;
- Smoker
- Being unable to understand, follow objectives and methods due to cognition or language problems;
- Be under chronic use of medications;
- 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
- Subject under administrative or judicial control
- All eating disorders
Study Plan
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.
|
In this study, the volunteers will be followed during one year. The wellbeing will be followed with :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alternate Healthy Eating Index-2010 (AHEI-2010) score
Time Frame: over a 1-year period
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calculated by Food Frequency Questionnaires
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over a 1-year period
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe PISON, MD, PhD, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 38RC16.019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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