Clinical trial NCT01656928: Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters
Official title: Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters: a Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 375
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: Change in Fruit- and vegetable consumption
timeFrame: 0, 6, 12 months
Secondary outcomes:
measure: Change in Body Mass Index
timeFrame: 0, 6, and 12 months
measure: Change in Percent body fat
timeFrame: 0, 6 and 12 months
measure: Change in waist-to-height ratio
timeFrame: 0, 6 and 12 months
Other outcomes:
measure: Change in water consumption; Change in juice consumption
timeFrame: 0, 6 and 12 months
Locations:
city: Mannheim
country: Germany
facility: Mannheim Institute of Public Health, University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: University of Heidelberg, Mannheim Institute of Pubic Health
name: Joachim E Fischer, Professor Dr.med. MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.