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Completed

NCT Number: NCT00456911

Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control

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.

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Key information

Conditions

Primary Prevention Body Weight Body Weight Control Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Prevention Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Free-Living Participants

Paris, Île-de-France Region, 75, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fat and carbohydrate controlled diet

Behavioral

Primary outcomes

  1. changes in body mass index throughout the intervention

Secondary outcomes

  1. changes in nutritional intakes throughout the intervention

  2. changes in fat mass throughout the intervention

  3. changes in anthropometric indicators throughout the intervention

  4. changes in physical activity throughout the intervention

  5. changes in fasting blood indicators throughout the intervention (adults only)

  6. changes in food-related quality of life throughout the intervention (adults only)

Sponsors and collaborators

Lead sponsor

Centre d'Etudes et de Documentation du Sucre

Other

Collaborators

  • Avenance Enseignement
  • Fondation Louis Bonduelle
  • Ministry of Higher Education and Research, France
  • Paris Academy (Rectorat de Paris)

Registry information

Official study title

Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)

Acronym: ELPAS

Important dates

Study start
2005
Study completion
2006
First posted
Apr 5, 2007
Registry last updated
Feb 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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