NCT03171571

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2016

Typical duration 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

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months 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 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

April 11, 2017

Last Update Submit

April 17, 2018

Conditions

Keywords

eating BehaviorVolunteers

Outcome Measures

Primary Outcomes (1)

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

    calculated by Food Frequency Questionnaires

    over a 1-year period

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, SF36, dietary habits. * actimetry measurement * one year follow-up of weight, waist measurement * nutritional biomarkers

Coaching procedure

Eligibility Criteria

Age35 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • \< BMI \< 29
  • y \<Age \< 45 y
  • Live as a couple and and be the main person who prepares meals

You may not qualify if:

  • 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;
  • Pregnant women, feeding and parturient
  • Playing sports at a high level
  • Subject under administrative or judicial control
  • All eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiy Hospital Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Christophe PISON, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 11, 2017

First Posted

May 31, 2017

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations