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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00456911 |
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Date of registration:
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03/04/2007 |
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Primary sponsor: |
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Public title:
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Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control
ELPAS |
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Scientific title:
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Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé) |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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2020 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00456911 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind
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Countries of recruitment
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France
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Contacts
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Name:
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Paul VALENSI, MD |
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Affiliation:
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Department of Endocrinology, CRNH Ile-de-France, Jean Verdier Hospital, Bondy, France |
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Name:
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Alain BOULIER, MD, PHD |
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Affiliation:
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Department of Nutrition and Functional Investigations, INSERM U695, Bichat-Claude Bernard Hospital, Paris, France |
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Name:
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Monique ROMON, MD |
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Affiliation:
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Department of Nutrition, EA2694 Lille2 University, Lille, France |
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Name:
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Judith CHWALOW, PHD |
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Affiliation:
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Department of Nutrition, EA3502, Hôtel-Dieu, Paris, France |
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Name:
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Béatrice JOURET, MD |
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Affiliation:
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Department of Pediatrics, Children's Hospital, Toulouse, France |
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Name:
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Maïté TAUBER, MD |
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Affiliation:
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Department of Pediatrics, Children's Hospital, Toulouse, France |
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Name:
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Pierre COMBRIS, PHD |
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Affiliation:
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INRA-CORELA, Ivry-sur-Seine, France |
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Name:
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Charles COUET, MD |
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Affiliation:
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INSERM E211, Tours Hospital, Tours, France |
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Name:
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Chantal SIMON, MD, PhD |
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Affiliation:
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Louis Pasteur University, Medical Faculty, EA 1801, Strasbourg, France |
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Name:
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Damien PAINEAU, MS |
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Affiliation:
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Nutri-Health, Rueil-Malmaison, France |
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Name:
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Francis BORNET, MD, PHD |
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Affiliation:
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Nutri-Health, Rueil-Malmaison, France |
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Name:
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Dominique-Adèle CASSUTO, MD |
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Affiliation:
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Paris, France |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Body Weight Control
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Obesity Prevention
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Primary Prevention
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Intervention(s)
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Behavioral: Fat and carbohydrate controlled diet
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Primary Outcome(s)
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changes in body mass index throughout the intervention
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Secondary Outcome(s)
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changes in anthropometric indicators throughout the intervention
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changes in fasting blood indicators throughout the intervention (adults only)
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changes in fat mass throughout the intervention
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changes in food-related quality of life throughout the intervention (adults only)
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changes in nutritional intakes throughout the intervention
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changes in physical activity throughout the intervention
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Secondary ID(s)
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ELPAS 2002-RN31
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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