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

This study has been completed.
Sponsor:
Collaborators:
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
First received: April 3, 2007
Last updated: February 12, 2008
Last verified: April 2007
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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
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

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

No publications provided by Centre d'Etudes et de Documentation du Sucre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00456911     History of Changes
Other Study ID Numbers: ELPAS 2002-RN31
Study First Received: April 3, 2007
Last Updated: February 12, 2008
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

Additional relevant MeSH terms:
Body Weight
Obesity
Signs and Symptoms
 Overnutrition
Nutrition Disorders
Overweight

ClinicalTrials.gov processed this record on May 16, 2013