ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control (ELPAS)

This study has been completed.

Sponsors and Collaborators: Centre d'Etudes et de Documentation du Sucre
French Ministry of Research
Paris Academy (Rectorat de Paris)
Avenance Enseignement
Fondation Louis Bonduelle
Information provided by: Centre d'Etudes et de Documentation du Sucre
ClinicalTrials.gov Identifier: NCT00456911
  Purpose

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.


Condition Intervention
Primary Prevention
Obesity Prevention
Body Weight Control
Behavioral: Fat and carbohydrate controlled diet

MedlinePlus related topics:   Obesity   Obesity in Children  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)

Further study details as provided by Centre d'Etudes et de Documentation du Sucre:

Primary Outcome Measures:
  • changes in body mass index throughout the intervention

Secondary Outcome Measures:
  • 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)

Estimated Enrollment:   2020
Study Start Date:   March 2005
Study Completion Date:   July 2006

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.

  Eligibility
Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456911

Locations
France, Ile de France
Free-Living Participants    
      Paris, Ile de France, France, 75

Sponsors and Collaborators
Centre d'Etudes et de Documentation du Sucre
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    
  More Information

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

Publications indexed to this study:

Study ID Numbers:   ELPAS 2002-RN31
First Received:   April 3, 2007
Last Updated:   February 12, 2008
ClinicalTrials.gov Identifier:   NCT00456911
Health Authority:   France: Ministry of Health

Keywords provided by Centre d'Etudes et de Documentation du Sucre:
obesity  
prevention  
children  
adults  
family  
dietary
coaching
body mass index
fat mass

Study placed in the following topic categories:
Body Weight
Obesity
Overweight
Overnutrition

Additional relevant MeSH terms:
Signs and Symptoms
Nutrition Disorders

ClinicalTrials.gov processed this record on July 03, 2008




Links to all studies - primarily for crawlers