- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01656928
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Baden-Württemberg
-
Mannheim, Baden-Württemberg, Germany, 68167
- Mannheim Institute of Public Health, University of Heidelberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Waiting-list control
Allocation to waiting-list Control.
Receives intervention 6 months later.
|
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:
|
Active Comparator: Intervention
Allocation to intervention.
Directly starts with 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
0, 6, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
0, 6, and 12 months
|
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)
|
0, 6 and 12 months
|
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)
|
0, 6 and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
0, 6 and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joachim E Fischer, Professor Dr.med. MSc, University of Heidelberg, Mannheim Institute of Pubic Health
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CRTLasti_nutr_kiga
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