Matkassen-effekter av 3 månaders Intensiv Kostintervention Riktad Till Barn Med Fetma / Family Meals on Prescription- a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Changes from Baseline in Dietary habits at one year
研究概览
简要总结
"Matkassen - effekten av tre månaders intensiv kostintervention hos barn med fetma/ Family Meals on Prescription.- a randomized controlled trial : The aim of the study was to explore a novel approach for the treatment of obesity in children and adolescents through an intensive dietary intervention, consisting of receiving a weekly bag of groceries and recipes for five family meals at a reduced price for three months.
Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.
详细描述
Children between the age of 5-15 years receiving treatment for obesity at the pediatric clinics in Varberg and Kungsbacka were offered to participate in the trial.
The study population was divided into two arms including 60 patients in each arm:
- In the first arm the patients received care consistent with regional guidelines.
- In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months.
Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 5 to 15
- •attending the Paediatric Obesity Clinics in Kungsbacka or Varberg
排除标准
- •Younger than 5 or older than 15
研究组 & 干预措施
Controls
In the first arm the patients received care consistent with regional guidelines. Treatment as usual.
Dietary Intervention
In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months
干预措施: Dietary Intervention (Behavioral)
结局指标
主要结局
Changes from Baseline in Dietary habits at one year
时间窗: 1 year
Assessment of meal pattern and dietary composition through questionaire.
Changes from Baseline in BMI at 18 months
时间窗: 18 months
Changes in BMI SDS in the different intervention groups
Changes from Baseline in BMI at 3 months
时间窗: 3 months
Changes in BMI SDS in the different intervention groups
Changes from Baseline in BMI at 12 months
时间窗: 12 months
Changes in BMI SDS in the different intervention groups
Changes from Baseline in BMI at 24 months
时间窗: 24 months
Changes in BMI SDS in the different intervention groups
次要结局
- Changes from Baseline in metabolic parameters at 12 months(12 months after treatment intervention)
- Experience of intervention with in 1 year after intervention(with in 1 year after intervention)