| April 3, 2007 |
| February 12, 2008 |
| March 2005 |
| |
| changes in body mass index throughout the intervention |
| Same as current |
| Complete list of historical versions of study NCT00456911 on ClinicalTrials.gov Archive Site |
- 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)
|
| Same as current |
| |
| Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control |
| Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé) |
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. |
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. |
| |
| Interventional |
| Other, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
- Primary Prevention
- Obesity Prevention
- Body Weight Control
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| Behavioral: Fat and carbohydrate controlled diet |
| |
| Paineau DL, Beaufils F, Boulier A, Cassuto DA, Chwalow J, Combris P, Couet C, Jouret B, Lafay L, Laville M, Mahe S, Ricour C, Romon M, Simon C, Tauber M, Valensi P, Chapalain V, Zourabichvili O, Bornet F. Family dietary coaching to improve nutritional intakes and body weight control: a randomized controlled trial. Arch Pediatr Adolesc Med. 2008 Jan;162(1):34-43. |
| |
| Completed |
| 2020 |
| July 2006 |
|
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 |
| Both |
| 6 Years to 65 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| France |
| |
| NCT00456911 |
|
| ELPAS 2002-RN31 |
| 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 |
|
|
| Centre d'Etudes et de Documentation du Sucre |
| April 2007 |