Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters

NCT ID: NCT01656928

Last Updated: 2012-08-03

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

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-04-30

Brief Summary

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This study assesses the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.

Detailed Description

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Objective: To assess the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.

Design: Using a cluster-randomized study design with waiting-list controls, we test a six-month intervention administered once weekly by a nutritional expert consisting of joint meal preparation and activities for children and parents like tasting and preparing nutritious, fresh foods. At baseline, six and twelve months, a parent-completed questionnaire assesses fruit and vegetable intake (primary outcomes) and water and sugared drink consumption (other outcomes). Direct measurement assessed BMI, percentage body fat (skin fold thicknesses) and waist-to-height-ratio. An intention-to-treat analysis used random effects panel regression models to assess the intervention effect, adjusted for each child's age, gender, immigrant background and maternal education.

Setting: 18 Preschools from three south German regions. Subjects: Healthy children from three to seven years of age.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Waiting-list control

Allocation to waiting-list Control. Receives intervention 6 months later.

Group Type OTHER

preschool-based nutritional intervention

Intervention Type BEHAVIORAL

6-month intervention administered once weekly by a nutrition expert consisting of joint meal preparation and activities for children and parents such as tasting and preparing nutritious, fresh foods.

Intervention

Allocation to intervention. Directly starts with nutritional intervention.

Group Type ACTIVE_COMPARATOR

preschool-based nutritional intervention

Intervention Type BEHAVIORAL

6-month intervention administered once weekly by a nutrition expert consisting of joint meal preparation and activities for children and parents such as tasting and preparing nutritious, fresh foods.

Interventions

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preschool-based nutritional intervention

6-month intervention administered once weekly by a nutrition expert consisting of joint meal preparation and activities for children and parents such as tasting and preparing nutritious, fresh foods.

Intervention Type BEHAVIORAL

Other Intervention Names

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Nutritional Module of program "Komm mit in das gesunde Boot"

Eligibility Criteria

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Inclusion Criteria

* Pre-schools were eligible to participate in the study if they were located in one of three predefined regions and had applied to participate in the nutritional intervention module of a state-sponsored health promotion programme 'Komm mit in das gesunde Boot' ('Come aboard the health boat'), with at least fifteen children participating.
* Healthy children in eligible preschools

Exclusion Criteria

* Age under 3 years or above 7 years
* Serious health problems
* Genetic conditions
* Metabolic diseases
* Acute infectious diseases
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Joachim E. Fischer

Professor Dr. med. MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joachim E Fischer, Professor Dr.med. MSc

Role: PRINCIPAL_INVESTIGATOR

University of Heidelberg, Mannheim Institute of Pubic Health

Locations

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Mannheim Institute of Public Health, University of Heidelberg

Mannheim, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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De Bock F, Breitenstein L, Fischer JE. Positive impact of a pre-school-based nutritional intervention on children's fruit and vegetable intake: results of a cluster-randomized trial. Public Health Nutr. 2012 Mar;15(3):466-75. doi: 10.1017/S136898001100200X. Epub 2011 Aug 23.

Reference Type RESULT
PMID: 21859516 (View on PubMed)

Other Identifiers

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CRTLasti_nutr_kiga

Identifier Type: -

Identifier Source: org_study_id