Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control - Tabular View

Tracking Information

First Received Date ^ICMJE

April 3, 2007

Last Updated Date

February 12, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

changes in body mass index throughout the intervention

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00456911 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)
changes in food-related quality of life throughout the intervention (adults only)

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control

Official Title ^ICMJE

Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)

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.

Detailed Description

Insufficient evidence supports the feasibility and the efficacy of current nutritional recommendations to prevent obesity. The purpose of this study is to test the hypothesis that family dietary coaching would improve nutritional intakes and health indicators in free-living children and adults.

Intervention: the 1013 participating families (1013 children and 1013 parents) are randomly assigned to Group A (advice to reduce fat and to increase complex carbohydrates), Group B (advice to reduce both fat and sugars and to increase complex carbohydrates) or a control group (no advice). GA and GB receive monthly phone counseling and Internet-based monitoring. Main outcome measures are changes in nutritional intakes and body mass index throughout the intervention in both children and adults. Secondary outcomes included changes in fat mass, physical activity, fasting blood indicators and food-related quality of life.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Primary Prevention
Obesity Prevention
Body Weight Control

Intervention ^ICMJE

Behavioral: Fat and carbohydrate controlled diet

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2020

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria: no inclusion criteria were based on pathological, ethnical or socio-educative indicators

Gender

Both

Ages

6 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00456911

Responsible Party

Study ID Numbers ^ICMJE

ELPAS 2002-RN31

Study Sponsor ^ICMJE

Centre d'Etudes et de Documentation du Sucre

Collaborators ^ICMJE

French Ministry of Research
Paris Academy (Rectorat de Paris)
Avenance Enseignement
Fondation Louis Bonduelle

Investigators ^ICMJE

Study Chair:	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
Principal Investigator:	Paul VALENSI, MD	Department of Endocrinology, CRNH Ile-de-France, Jean Verdier Hospital, Bondy, France
Study Chair:	Francis BORNET, MD, PHD	Nutri-Health, Rueil-Malmaison, France
Study Chair:	Damien PAINEAU, MS	Nutri-Health, Rueil-Malmaison, France

Information Provided By

Centre d'Etudes et de Documentation du Sucre

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP