NCT03411603

Brief Summary

The objectives of the study are to assess the validity of Nestlé reformulation criteria in two national dietary surveys: the US NHANES 2011, and the French INCA2 2006-07.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6,991

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

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

January 1, 2006

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

7 years

First QC Date

January 11, 2018

Last Update Submit

January 25, 2018

Conditions

Nutrition Poor

Keywords

nutrient profiling

Outcome Measures

Primary Outcomes (2)

  • Healthy Eating Index 2010

    Measure of dietary quality for the NHANES Survey, based on reported dietary intakes

    2011-12

  • PNNS-GS diet score

    Measure of dietary quality for the French INCA2 Survey, based on reported dietary intakes

    2006-07

Secondary Outcomes (3)

  • Mean Adequacy Ratio

    2006-07 and 2011-12

  • Mean Excess Ratio

    2006-07 and 2011-12

  • Energy density

    2006-07 and 2011-12

Study Arms (2)

INCA2 2006-07

French National Dietary Intake Survey, conducted in 2006-2007 by the French Agency for Food, Environmental and Occupational Health Safety. Adults aged 18y and over, n=1918 included in the analyses.

Other: Diet and socio-demographic questionnaires

NHANES 2011-12

Wave 2011-12 of the National Health and Nutrition Examination Survey, the US national dietary intake Survey, conducted by the Centers for Disease Control and Prevention (CDC) Adults aged 18y and over, n=5073 included in the analyses.

Other: Diet and socio-demographic questionnaires

Interventions

Diet and socio-demographic questionnairesOTHER

24-hr recall or food diary questionnaires; socio-demographic questionnaires

INCA2 2006-07NHANES 2011-12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Representative samples of the US and French adult populations

You may qualify if:

  • All participants of INCA2 and NHANES 2011-12 surveys

You may not qualify if:

  • Missing dietary intake data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Malnutrition

Interventions

Diet

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kathryn Porter

    Centers for Disease Control and Prevention

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 26, 2018

Study Start

January 1, 2006

Primary Completion

December 31, 2012

Study Completion

December 1, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

The NHANES 2011-12 and INCA2 data are available to other researchers via the respective websites.