We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01656928
First Posted: August 3, 2012
Last Update Posted: August 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joachim E. Fischer, University of Heidelberg
  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
Intervention Model: Parallel Assignment
Masking: Single (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

Further study details as provided by Joachim E. Fischer, University of Heidelberg:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)

  • 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)

  • 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)


Other Outcome Measures:
  • 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)


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 27, 2012
First Posted: August 3, 2012
Last Update Posted: August 3, 2012
Last Verified: July 2012