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

This study has been completed.
Sponsor:
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
  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 Heidelberg University:

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
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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
Heidelberg University
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
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014