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

February 12, 2008 updated by: Centre d'Etudes et de Documentation du Sucre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

2020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75
        • Free-Living Participants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
changes in body mass index throughout the intervention

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Etudes et de Documentation du Sucre

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Estimate)

February 13, 2008

Last Update Submitted That Met QC Criteria

February 12, 2008

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELPAS 2002-RN31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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