Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters
This study has been completed.
Sponsor:
University of Heidelberg
Information provided by (Responsible Party):
Joachim E. Fischer, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01656928
First received: July 27, 2012
Last updated: August 2, 2012
Last verified: July 2012
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Purpose
This study assesses the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: preschool-based nutritional intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters: a Cluster-randomized Trial |
Resource links provided by NLM:
Further study details as provided by University of Heidelberg:
Primary Outcome Measures:
- Change in Fruit- and vegetable consumption [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
Secondary Outcome Measures:
- Change in Body Mass Index [ Time Frame: 0, 6, and 12 months ] [ Designated as safety issue: No ]Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
- Change in Percent body fat [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
- Change in waist-to-height ratio [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
Other Outcome Measures:
- Change in water consumption; Change in juice consumption [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
| Enrollment: | 375 |
| Study Start Date: | September 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Nutritional Module of program "Komm mit in das gesunde Boot"
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 7 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656928
Locations
| Germany | |
| Mannheim Institute of Public Health, University of Heidelberg | |
| Mannheim, Baden-Württemberg, Germany, 68167 | |
Sponsors and Collaborators
University of Heidelberg
Investigators
| Principal Investigator: | Joachim E Fischer, Professor Dr.med. MSc | University of Heidelberg, Mannheim Institute of Pubic Health |
More Information
Additional Information:
Publications:
| Responsible Party: | Joachim E. Fischer, Professor Dr. med. MSc, University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT01656928 History of Changes |
| Other Study ID Numbers: | CRTLasti_nutr_kiga |
| Study First Received: | July 27, 2012 |
| Last Updated: | August 2, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Obesity Food Habits Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Habits |
ClinicalTrials.gov processed this record on June 18, 2013