Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control

NCT ID: NCT00456911

Last Updated: 2008-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Primary Prevention Obesity Prevention Body Weight Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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Fat and carbohydrate controlled diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* second- or third-grade pupils
* affiliation with the French Health Care System
* written informed consent
Minimum Eligible Age

6 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Higher Education and Research, France

OTHER_GOV

Sponsor Role collaborator

Paris Academy (Rectorat de Paris)

UNKNOWN

Sponsor Role collaborator

Avenance Enseignement

UNKNOWN

Sponsor Role collaborator

Fondation Louis Bonduelle

UNKNOWN

Sponsor Role collaborator

Centre d'Etudes et de Documentation du Sucre

OTHER

Sponsor Role lead

Principal Investigators

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Alain BOULIER, MD, PHD

Role: STUDY_CHAIR

Department of Nutrition and Functional Investigations, INSERM U695, Bichat-Claude Bernard Hospital, Paris, France

Dominique-Adèle CASSUTO, MD

Role: STUDY_CHAIR

Paris, France

Judith CHWALOW, PHD

Role: STUDY_CHAIR

Department of Nutrition, EA3502, Hôtel-Dieu, Paris, France

Pierre COMBRIS, PHD

Role: STUDY_CHAIR

INRA-CORELA, Ivry-sur-Seine, France

Charles COUET, MD

Role: STUDY_CHAIR

INSERM E211, Tours Hospital, Tours, France

Béatrice JOURET, MD

Role: STUDY_CHAIR

Department of Pediatrics, Children's Hospital, Toulouse, France

Monique ROMON, MD

Role: STUDY_CHAIR

Department of Nutrition, EA2694 Lille2 University, Lille, France

Chantal SIMON, MD, PhD

Role: STUDY_CHAIR

Louis Pasteur University, Medical Faculty, EA 1801, Strasbourg, France

Maïté TAUBER, MD

Role: STUDY_CHAIR

Department of Pediatrics, Children's Hospital, Toulouse, France

Paul VALENSI, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, CRNH Ile-de-France, Jean Verdier Hospital, Bondy, France

Francis BORNET, MD, PHD

Role: STUDY_CHAIR

Nutri-Health, Rueil-Malmaison, France

Damien PAINEAU, MS

Role: STUDY_CHAIR

Nutri-Health, Rueil-Malmaison, France

Locations

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Free-Living Participants

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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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. doi: 10.1001/archpediatrics.2007.2.

Reference Type DERIVED
PMID: 18180410 (View on PubMed)

Related Links

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http://www.sante-jeunesse-sports.gouv.fr

French Ministry of Research website

Other Identifiers

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ELPAS 2002-RN31

Identifier Type: -

Identifier Source: org_study_id

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