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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

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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.




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