Effects of a Pre-school-based Nutritional Intervention on Children's Eating Behavior and Anthropometric Parameters: a Cluster-randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Change in Fruit- and vegetable consumption
研究概览
简要总结
This study assesses the impact of a nutritional intervention aimed at reducing childhood overweight in German preschoolers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age under 3 years or above 7 years
- •Serious health problems
- •Genetic conditions
- •Metabolic diseases
- •Acute infectious diseases
研究组 & 干预措施
Waiting-list control
Allocation to waiting-list Control. Receives intervention 6 months later.
干预措施: preschool-based nutritional intervention (Behavioral)
Intervention
Allocation to intervention. Directly starts with nutritional intervention.
干预措施: preschool-based nutritional intervention (Behavioral)
结局指标
主要结局
Change in Fruit- and vegetable consumption
时间窗: 0, 6, 12 months
Before intervention (0 months), at the end of intervention (6 months), six months after intervention (12 months)
次要结局
- 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)
研究者
Joachim E. Fischer
Professor Dr. med. MSc
Heidelberg University