HealthyC2H2NCT03169088
"Cook to Health Study 2 ": Monitoring Wellbeing and Health in the Community (Main Study)
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 25 to 50 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
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 1 Apr 2019
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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)
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 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
- 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, IPAQ, 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: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Mar 2017
- Primary completion1 Oct 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Model description
- monocentric study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Christophe PISON, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169088
- Sponsor's protocol ID
- 38RC16.283
- Acronym
- C2H2
- Status last verified
- Aug 2019
- First submitted
- 11 Apr 2017
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hood L, Auffray C. Participatory medicine: a driving force for revolutionizing healthcare. Genome Med. 2013 Dec 23;5(12):110. doi: 10.1186/gm514. eCollection 2013. No abstract available.
PubMed 24360023Hood L, Flores M. A personal view on systems medicine and the emergence of proactive P4 medicine: predictive, preventive, personalized and participatory. N Biotechnol. 2012 Sep 15;29(6):613-24. doi: 10.1016/j.nbt.2012.03.004. Epub 2012 Mar 18.
PubMed 22450380Hood L, Price ND. Demystifying disease, democratizing health care. Sci Transl Med. 2014 Feb 26;6(225):225ed5. doi: 10.1126/scitranslmed.3008665. No abstract available.
PubMed 24574336Dzau VJ, Ginsburg GS, Van Nuys K, Agus D, Goldman D. Aligning incentives to fulfil the promise of personalised medicine. Lancet. 2015 May 23;385(9982):2118-9. doi: 10.1016/S0140-6736(15)60722-X. Epub 2015 May 6. No abstract available.
PubMed 25957453Kramer CK. Weight loss is a useful therapeutic objective. Can J Cardiol. 2015 Feb;31(2):211-5. doi: 10.1016/j.cjca.2014.08.003. Epub 2014 Aug 14.
PubMed 25661556Scalbert A, Brennan L, Manach C, Andres-Lacueva C, Dragsted LO, Draper J, Rappaport SM, van der Hooft JJ, Wishart DS. The food metabolome: a window over dietary exposure. Am J Clin Nutr. 2014 Jun;99(6):1286-308. doi: 10.3945/ajcn.113.076133. Epub 2014 Apr 23.
PubMed 24760973Chiuve SE, Fung TT, Rimm EB, Hu FB, McCullough ML, Wang M, Stampfer MJ, Willett WC. Alternative dietary indices both strongly predict risk of chronic disease. J Nutr. 2012 Jun;142(6):1009-18. doi: 10.3945/jn.111.157222. Epub 2012 Apr 18.
PubMed 22513989Gooding HC, Shay CM, Ning H, Gillman MW, Chiuve SE, Reis JP, Allen NB, Lloyd-Jones DM. Optimal Lifestyle Components in Young Adulthood Are Associated With Maintaining the Ideal Cardiovascular Health Profile Into Middle Age. J Am Heart Assoc. 2015 Oct 29;4(11):e002048. doi: 10.1161/JAHA.115.002048.
PubMed 26514160Castellano-Escuder P, Gonzalez-Dominguez R, Vaillant MF, Casas-Agustench P, Hidalgo-Liberona N, Estanyol-Torres N, Wilson T, Beckmann M, Lloyd AJ, Oberli M, Moinard C, Pison C, Borel JC, Joyeux-Faure M, Sicard M, Artemova S, Terrisse H, Dancer P, Draper J, Sanchez-Pla A, Andres-Lacueva C. Assessing Adherence to Healthy Dietary Habits Through the Urinary Food Metabolome: Results From a European Two-Center Study. Front Nutr. 2022 Jun 9;9:880770. doi: 10.3389/fnut.2022.880770. eCollection 2022.
PubMed 35757242
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Cook to Health 2" : Monitoring Wellbeing and Health in the Community
- ClinicalTrials.gov ID
- NCT03169088
- Acronym / sponsor ID
- C2H2 / 38RC16.283
- Conditions
- Healthy
- Keywords
- eating Behavior, Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 30 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.
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)
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- monocentric study
| 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
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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, IPAQ, 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: 1 year
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 9 Aug 2019.
- Background: PubMed 24360023Hood L, Auffray C. Participatory medicine: a driving force for revolutionizing healthcare. Genome Med. 2013 Dec 23;5(12):110. doi: 10.1186/gm514. eCollection 2013. No abstract available.
- Background: PubMed 22450380Hood L, Flores M. A personal view on systems medicine and the emergence of proactive P4 medicine: predictive, preventive, personalized and participatory. N Biotechnol. 2012 Sep 15;29(6):613-24. doi: 10.1016/j.nbt.2012.03.004. Epub 2012 Mar 18.
- Background: PubMed 24574336Hood L, Price ND. Demystifying disease, democratizing health care. Sci Transl Med. 2014 Feb 26;6(225):225ed5. doi: 10.1126/scitranslmed.3008665. No abstract available.
- Background: PubMed 25957453Dzau VJ, Ginsburg GS, Van Nuys K, Agus D, Goldman D. Aligning incentives to fulfil the promise of personalised medicine. Lancet. 2015 May 23;385(9982):2118-9. doi: 10.1016/S0140-6736(15)60722-X. Epub 2015 May 6. No abstract available.
- Background: PubMed 25661556Kramer CK. Weight loss is a useful therapeutic objective. Can J Cardiol. 2015 Feb;31(2):211-5. doi: 10.1016/j.cjca.2014.08.003. Epub 2014 Aug 14.
- Background: PubMed 24760973Scalbert A, Brennan L, Manach C, Andres-Lacueva C, Dragsted LO, Draper J, Rappaport SM, van der Hooft JJ, Wishart DS. The food metabolome: a window over dietary exposure. Am J Clin Nutr. 2014 Jun;99(6):1286-308. doi: 10.3945/ajcn.113.076133. Epub 2014 Apr 23.
- Background: PubMed 22513989Chiuve SE, Fung TT, Rimm EB, Hu FB, McCullough ML, Wang M, Stampfer MJ, Willett WC. Alternative dietary indices both strongly predict risk of chronic disease. J Nutr. 2012 Jun;142(6):1009-18. doi: 10.3945/jn.111.157222. Epub 2012 Apr 18.
- Background: PubMed 26514160Gooding HC, Shay CM, Ning H, Gillman MW, Chiuve SE, Reis JP, Allen NB, Lloyd-Jones DM. Optimal Lifestyle Components in Young Adulthood Are Associated With Maintaining the Ideal Cardiovascular Health Profile Into Middle Age. J Am Heart Assoc. 2015 Oct 29;4(11):e002048. doi: 10.1161/JAHA.115.002048.
- Derived from this study: PubMed 35757242Castellano-Escuder P, Gonzalez-Dominguez R, Vaillant MF, Casas-Agustench P, Hidalgo-Liberona N, Estanyol-Torres N, Wilson T, Beckmann M, Lloyd AJ, Oberli M, Moinard C, Pison C, Borel JC, Joyeux-Faure M, Sicard M, Artemova S, Terrisse H, Dancer P, Draper J, Sanchez-Pla A, Andres-Lacueva C. Assessing Adherence to Healthy Dietary Habits Through the Urinary Food Metabolome: Results From a European Two-Center Study. Front Nutr. 2022 Jun 9;9:880770. doi: 10.3389/fnut.2022.880770. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, Pr 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?
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 9 Aug 2019. 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: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03169088, which also lists 9 linked publications.
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 9 Aug 2019.