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

Study Overview
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: preschool-based nutritional intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |