NCT00456911

Brief Summary

We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,020

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

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, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
Last Updated

February 13, 2008

Status Verified

April 1, 2007

First QC Date

April 3, 2007

Last Update Submit

February 12, 2008

Conditions

Primary PreventionObesity PreventionBody Weight Control

Keywords

obesitypreventionchildrenadultsfamilydietarycoachingbody mass indexfat mass

Outcome Measures

Primary Outcomes (1)

  • changes in body mass index throughout the intervention

Secondary Outcomes (6)

  • changes in nutritional intakes throughout the intervention

  • changes in fat mass throughout the intervention

  • changes in anthropometric indicators throughout the intervention

  • changes in physical activity throughout the intervention

  • changes in fasting blood indicators throughout the intervention (adults only)

  • +1 more secondary outcomes

Interventions

Fat and carbohydrate controlled dietBEHAVIORAL

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • second- or third-grade pupils
  • affiliation with the French Health Care System
  • written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Free-Living Participants

Paris, Île-de-France Region, 75, France

Location

Related Publications (1)

  • Paineau DL, Beaufils F, Boulier A, Cassuto DA, Chwalow J, Combris P, Couet C, Jouret B, Lafay L, Laville M, Mahe S, Ricour C, Romon M, Simon C, Tauber M, Valensi P, Chapalain V, Zourabichvili O, Bornet F. Family dietary coaching to improve nutritional intakes and body weight control: a randomized controlled trial. Arch Pediatr Adolesc Med. 2008 Jan;162(1):34-43. doi: 10.1001/archpediatrics.2007.2.

    PMID: 18180410DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Interventions

CD36 Antigens

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Platelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Officials

  • Alain BOULIER, MD, PHD

    Department of Nutrition and Functional Investigations, INSERM U695, Bichat-Claude Bernard Hospital, Paris, France

    STUDY CHAIR

  • Dominique-Adèle CASSUTO, MD

    Paris, France

    STUDY CHAIR

  • Judith CHWALOW, PHD

    Department of Nutrition, EA3502, Hôtel-Dieu, Paris, France

    STUDY CHAIR

  • Pierre COMBRIS, PHD

    INRA-CORELA, Ivry-sur-Seine, France

    STUDY CHAIR

  • Charles COUET, MD

    INSERM E211, Tours Hospital, Tours, France

    STUDY CHAIR

  • Béatrice JOURET, MD

    Department of Pediatrics, Children's Hospital, Toulouse, France

    STUDY CHAIR

  • Monique ROMON, MD

    Department of Nutrition, EA2694 Lille2 University, Lille, France

    STUDY CHAIR

  • Chantal SIMON, MD, PhD

    Louis Pasteur University, Medical Faculty, EA 1801, Strasbourg, France

    STUDY CHAIR

  • Maïté TAUBER, MD

    Department of Pediatrics, Children's Hospital, Toulouse, France

    STUDY CHAIR

  • Paul VALENSI, MD

    Department of Endocrinology, CRNH Ile-de-France, Jean Verdier Hospital, Bondy, France

    PRINCIPAL INVESTIGATOR

  • Francis BORNET, MD, PHD

    Nutri-Health, Rueil-Malmaison, France

    STUDY CHAIR

  • Damien PAINEAU, MS

    Nutri-Health, Rueil-Malmaison, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 5, 2007

Study Start

March 1, 2005

Study Completion

July 1, 2006

Last Updated

February 13, 2008

Record last verified: 2007-04

Locations

FR(1)