Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control

Primary Prevention Clinical Trial

— ELPAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456911
• Other study ID #: ELPAS 2002-RN31
• Status: Completed
• Phase: N/A
• First received: April 3, 2007
• Last updated: February 12, 2008
• Start date: March 2005
• Est. completion date: July 2006

Study information

• Verified date: April 2007
• Source: Centre d'Etudes et de Documentation du Sucre
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2020
• Est. completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Body Weight
• Body Weight Control
• Obesity Prevention
• Primary Prevention

Intervention

Behavioral:
• Fat and carbohydrate controlled diet

Locations

Country	Name	City	State
France	Free-Living Participants	Paris	Ile de France

Sponsors (5)

Lead Sponsor	Collaborator
Centre d'Etudes et de Documentation du Sucre	Avenance Enseignement, Fondation Louis Bonduelle, Ministry of Higher Education and Research, France, Paris Academy (Rectorat de Paris)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in body mass index throughout the intervention
Secondary	changes in nutritional intakes throughout the intervention
Secondary	changes in fat mass throughout the intervention
Secondary	changes in anthropometric indicators throughout the intervention
Secondary	changes in physical activity throughout the intervention
Secondary	changes in fasting blood indicators throughout the intervention (adults only)
Secondary	changes in food-related quality of life throughout the intervention (adults only)

External Links

•   French Ministry of Research website