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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: preschool-based nutritional intervention

• Registration Number: NCT01656928
• Lead Sponsor: Heidelberg University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2010-09
• Study Completion: 2011-04
• Status Verified: 2012-07
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-08-02
• Last Update Submitted: 2012-08-02
• Study First Posted: 2012-08-03
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waiting-list control	preschool-based nutritional intervention	Allocation to waiting-list Control. Receives intervention 6 months later.
Intervention	preschool-based nutritional intervention	Allocation to intervention. Directly starts with nutritional intervention.

Primary Outcome Measures

Name	Time	Method
Change in Fruit- and vegetable consumption	0, 6, 12 months	Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)

Secondary Outcome Measures

Name	Time	Method
Change in Body Mass Index	0, 6, and 12 months	Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
Change in Percent body fat	0, 6 and 12 months	Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
Change in waist-to-height ratio	0, 6 and 12 months	Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)

Trial Locations

Locations (1)

Mannheim Institute of Public Health, University of Heidelberg; 🇩🇪 Mannheim, Baden-Württemberg, Germany