NCT03169088

Brief 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. 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

April 11, 2017

Last Update Submit

August 7, 2019

Conditions

Keywords

eating BehaviorVolunteers

Outcome Measures

Primary Outcomes (1)

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

    calculated by Food Frequency Questionnaires

    1 year

Study Arms (1)

Coaching procedure

EXPERIMENTAL

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

Other: Coaching procedure

Interventions

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

Coaching procedure

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

Related Publications (9)

  • 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.

    PMID: 24360023BACKGROUND
  • Hood 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.

    PMID: 22450380BACKGROUND
  • Hood 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.

    PMID: 24574336BACKGROUND
  • Dzau 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.

    PMID: 25957453BACKGROUND
  • Kramer 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.

    PMID: 25661556BACKGROUND
  • Scalbert 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.

    PMID: 24760973BACKGROUND
  • Chiuve 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.

    PMID: 22513989BACKGROUND
  • Gooding 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.

    PMID: 26514160BACKGROUND
  • Castellano-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.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Christophe PISON, Pr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: monocentric study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2017

First Posted

May 30, 2017

Study Start

March 1, 2017

Primary Completion

October 1, 2018

Study Completion

April 1, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations