Nutritional Status of South Spanish Children: A Mediterranean Diet Nutritional Intervention of Children With Insulin Resistance From a Rural Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- HbA1c levels
研究概览
简要总结
Prediabetes is a pathological condition where the blood glucose concentration is higher than normal concentrations but lower than those considered in type 2 diabetes mellitus (DM2) diagnosis. Until a few years ago, this prediabetes occurred in adults with associated risk factors such as being overweight or obese, sedentary lifestyle, poor eating habits, and cardiovascular problems, among others. Recently, it has begun to be detected in children, with family eating habits becoming more critical. Therefore, the objectives of this study were to determine the efficacy of the nutritional intervention in children with analytical data on pre-diabetes; and the secondary ones proposed were to evaluate if an individualized and directed nutritional intervention compared to the standardized one supposes an improvement in children's dietary habits and to determine if nutritional education improves anthropometric parameters and adherence to a Mediterranean diet, through the evaluation of the Mediterranean Diet Quality Index (KIDMED).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of HbA1c levels between 5.7 and 6.4% in the blood tests
- •Signed informed consent by the minor
- •Signed informed consent by the minor's parents or guardians.
排除标准
- •Presence of HbA1c levels below 5.7%
- •Presence of HbA1c levels above 6.4%
- •Presence of pathological metabolic diseases, such as diabetes or metabolic syndrome
- •Lack of the signed informed consent by the minor and legal guardian
结局指标
主要结局
HbA1c levels
时间窗: Up to six months
The HbA1c were measured at the initial visit (V0) and during the last visit (V4)
次要结局
- Height (m2)(Up to six months)
- Weight (kg)(Up to six months)
- Waist circumference (cm)(Up to six months)
- The Food Frequency Questionnaire (FFQ)(Up to six months)
- Body mass index (kg/m2)(Up to six months)
- Hip circumference(cm)(Up to six months)
- Arm circumference (cm)(Up to six months)
- Validated nutritional assessment questionnaire: adherence to the Mediterranean diet (KIDMED)(Up to six months)
- Decalogue of healthy eating(Up to six months)
研究者
Pilar Aparicio Martinez
Researcher and Lecture at the University and IMIBIC
Universidad de Córdoba