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Clinical Trials/NCT01656928
NCT01656928
Completed
Not Applicable

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

Heidelberg University1 site in 1 country375 target enrollmentSeptember 2008
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Heidelberg University
Enrollment
375
Locations
1
Primary Endpoint
Change in Fruit- and vegetable consumption
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
April 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joachim E. Fischer

Professor Dr. med. MSc

Heidelberg University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Fruit- and vegetable consumption

Time Frame: 0, 6, 12 months

Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)

Secondary Outcomes

  • Change in Body Mass Index(0, 6, and 12 months)
  • Change in Percent body fat(0, 6 and 12 months)
  • Change in waist-to-height ratio(0, 6 and 12 months)

Study Sites (1)

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