Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters
1 other identifier
interventional
375
1 country
1
Brief Summary
This study assesses the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Sep 2008
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 27, 2012
CompletedFirst Posted
Study publicly available on registry
August 3, 2012
CompletedAugust 3, 2012
July 1, 2012
2 years
July 27, 2012
August 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Other Outcomes (1)
Change in water consumption; Change in juice consumption
0, 6 and 12 months
Study Arms (2)
Waiting-list control
OTHERAllocation to waiting-list Control. Receives intervention 6 months later.
Intervention
ACTIVE COMPARATORAllocation to intervention. Directly starts with nutritional intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age under 3 years or above 7 years
- Serious health problems
- Genetic conditions
- Metabolic diseases
- Acute infectious diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mannheim Institute of Public Health, University of Heidelberg
Mannheim, Baden-Wurttemberg, 68167, Germany
Related Publications (1)
De Bock F, Breitenstein L, Fischer JE. Positive impact of a pre-school-based nutritional intervention on children's fruit and vegetable intake: results of a cluster-randomized trial. Public Health Nutr. 2012 Mar;15(3):466-75. doi: 10.1017/S136898001100200X. Epub 2011 Aug 23.
PMID: 21859516RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joachim E Fischer, Professor Dr.med. MSc
University of Heidelberg, Mannheim Institute of Pubic Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Dr. med. MSc
Study Record Dates
First Submitted
July 27, 2012
First Posted
August 3, 2012
Study Start
September 1, 2008
Primary Completion
September 1, 2010
Study Completion
April 1, 2011
Last Updated
August 3, 2012
Record last verified: 2012-07