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Completed

NCT Number: NCT01656928

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

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

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mannheim Institute of Public Health, University of Heidelberg

Mannheim, Baden-Wurttemberg, 68167, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preschool-based nutritional intervention

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.

Other names: Nutritional Module of program "Komm mit in das gesunde Boot"

Primary outcomes

  1. 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

  1. Change in Body Mass Index

    Time frame: 0, 6, and 12 months

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

  2. Change in Percent body fat

    Time frame: 0, 6 and 12 months

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

  3. Change in waist-to-height ratio

    Time frame: 0, 6 and 12 months

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

Other outcomes

  1. Change in water consumption; Change in juice consumption

    Time frame: 0, 6 and 12 months

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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 3, 2012
Registry last updated
Aug 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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