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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00456911
Other study ID # ELPAS 2002-RN31
Secondary ID
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
Est. primary completion date
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


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)
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