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

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ClinicalTrials.gov Identifier: NCT00456911
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : February 13, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Primary Prevention Obesity Prevention Body Weight Control Behavioral: Fat and carbohydrate controlled diet

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)
Study Start Date : March 2005
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. changes in nutritional intakes throughout the intervention
  2. changes in fat mass throughout the intervention
  3. changes in anthropometric indicators throughout the intervention
  4. changes in physical activity throughout the intervention
  5. changes in fasting blood indicators throughout the intervention (adults only)
  6. changes in food-related quality of life throughout the intervention (adults only)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456911


Locations
France
Free-Living Participants
Paris, Ile de France, France, 75
Sponsors and Collaborators
Centre d'Etudes et de Documentation du Sucre
Ministry of Higher Education and Research, France
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:
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
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: February 13, 2008
Last Verified: April 2007

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
Signs and Symptoms