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| 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 |
| 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) |
| Estimated Enrollment: | 2020 |
| Study Start Date: | March 2005 |
| Study Completion Date: | July 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria: no inclusion criteria were based on pathological, ethnical or socio-educative indicators
Contacts and Locations| France, Ile de France | |||||
| Free-Living Participants | |||||
| Paris, Ile de France, France, 75 | |||||
| Centre d'Etudes et de Documentation du Sucre |
| French Ministry of Research |
| Paris Academy (Rectorat de Paris) |
| Avenance Enseignement |
| Fondation Louis Bonduelle |
| 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 
  |
| 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 |
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