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

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Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control (ELPAS)

This study has been completed.
Information provided by Centre d'Etudes et de Documentation du Sucre

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

changes in body mass index throughout the intervention

Secondary Outcome Measure ^†

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)

Condition ^†

Primary Prevention
Obesity Prevention
Body Weight Control

Intervention ^†

Behavioral: Fat and carbohydrate controlled diet

MEDLINE PMIDs

Links

French Ministry of Research website This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

2020

Start Date ^†

March 2005

Completion Date

July 2006

Eligibility Criteria ^†

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 ^††

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00456911

Organization ID

ELPAS 2002-RN31

Secondary IDs ^††

Study Sponsor ^†

Centre d'Etudes et de Documentation du Sucre

Collaborators ^††

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

Investigators ^†

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

First Received Date ^†

April 3, 2007

Last Updated Date

February 12, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.