HealthyC2HNCT03171571
Personal Lifestyle Assistant for Better Health Through Nutrition
A study testing Coaching procedure in people with Healthy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Coaching procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- Pregnant women, feeding and parturient
- Playing sports at a high level
- Subject under administrative or judicial control
- All eating disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personal Lifestyle Assistant for Better Health Through Nutrition : Cook to Health Study
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.
Read the 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
- Conditions
- Healthy
- Being tested
- Coaching procedure
- Keywords
- eating Behavior, Volunteers
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching procedureOther
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 group | Role | What they receive |
|---|---|---|
| Coaching procedure | Experimental | Volunteers will received Updated National Dietary Guidelines about food and physical activity with a one year follow-up, plus connected coaching. Receives: Other: Coaching procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alternate Healthy Eating Index-2010 (AHEI-2010) score
calculated by Food Frequency Questionnaires
Measured: over a 1-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study startJun 2016
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Université Joseph Fourier, AGIR à Dom
- Responsible party
- Sponsor
- Investigators
- Christophe PISON, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171571
- Sponsor's protocol ID
- 38RC16.019
- Acronym
- C2H
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Lifestyle Assistant for Better Health Through Nutrition : Cook to Health Study
- ClinicalTrials.gov ID
- NCT03171571
- Acronym / sponsor ID
- C2H / 38RC16.019
- Conditions
- Healthy
- Keywords
- eating Behavior, Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Université Joseph Fourier, AGIR à Dom
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coaching procedure | Experimental | Other: Coaching procedureVolunteers will received Updated National Dietary Guidelines about food and physical activity with a one year follow-up, plus connected coaching. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching procedureIn 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 | Other | Coaching procedure |
Primary outcome
Alternate Healthy Eating Index-2010 (AHEI-2010) score
Time frame: over a 1-year period
calculated by Food Frequency Questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe PISON, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching procedure in people with Healthy, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alternate Healthy Eating Index-2010 (AHEI-2010) score (time frame: over a 1-year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.