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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: preschool-based nutritional intervention

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 Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Mannheim Institute of Public Health, University of Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Waiting-list control; Allocation to waiting-list Control. Receives intervention 6 months later.	Behavioral: 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.; Other Names: Nutritional Module of program "Komm mit in das gesunde Boot"
Active Comparator: Intervention; Allocation to intervention. Directly starts with nutritional intervention.	Behavioral: 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.; Other Names: Nutritional Module of program "Komm mit in das gesunde Boot"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fruit- and vegetable consumption	Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)	0, 6, 12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in water consumption; Change in juice consumption	Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)	0, 6 and 12 months

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Joachim E Fischer, Professor Dr.med. MSc, University of Heidelberg, Mannheim Institute of Pubic Health

Publications and helpful links

General Publications

• 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.

Helpful Links

• intervention website

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 27, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Estimate): August 3, 2012
• Last Update Submitted That Met QC Criteria: August 2, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: CRTLasti_nutr_kiga