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

July 27, 2012
August 2, 2012
September 2008
September 2010   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01656928 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
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)
Same as current
 
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

This study assesses the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Obesity
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"
  • Waiting-list control
    Allocation to waiting-list Control. Receives intervention 6 months later.
    Intervention: Behavioral: preschool-based nutritional intervention
  • Active Comparator: Intervention
    Allocation to intervention. Directly starts with nutritional intervention.
    Intervention: Behavioral: preschool-based nutritional intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
375
April 2011
September 2010   (final data collection date for primary outcome measure)

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
Both
3 Years to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01656928
CRTLasti_nutr_kiga
No
Joachim E. Fischer, University of Heidelberg
Heidelberg University
Not Provided
Principal Investigator: Joachim E Fischer, Professor Dr.med. MSc University of Heidelberg, Mannheim Institute of Pubic Health
Heidelberg University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP