跳至主要内容
临床试验/NCT03131284
NCT03131284已完成不适用

Prevention of Obesity in Toddlers (PROBIT): a Randomized Clinical Trial of Primary Pediatric Care From Birth Onwards.

Azienda Ospedaliera Universitaria Integrata Verona2 个研究点 分布在 1 个国家目标入组 569 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
569
试验地点
2
主要终点
Body mass index (BMI) at two years of age.

研究概览

简要总结

AIM:

to reduce the prevalence of overweight and obesity at two years of age in the intervention group compared to the control group.

METHODS:

Eleven primary paediatricians were randomized to the intervention group and intensively trained about the trial intervention. Each of them was asked to consecutively recruit the parents of at least 30 newborns taken in charge within the first six months of the study, and to provide them with standardized oral and written information on protective practices during all the well visits scheduled in the first two years of the child's life.

Another eleven primary paediatricians were randomized to the control group, and were asked to consecutively recruit the parents of at least 30 newborns taken in charge within the first six months of the study and to provide them with usual care and follow-up. When all recruited children have completed the second year of life, the two groups of toddlers will be compared as regards the prevalence of overweight/obesity, defined by WHO cut-offs of the weight/length ratio.

详细描述

INTRODUCTION:

Childhood overweight and obesity represent a serious public health emergency for most western and westernized countries. In fact, obesity prevalence has been increasing for several decades in these countries and weight excess is associated with severe psychological and physical complications, such as depression, diabetes, infertility and cardiovascular disease. As a consequence, childhood obesity is associated with a significant increase of the risk of premature death from endogenous causes. In the Northern Italy, the overall prevalence of overweight/obesity among school children is 25 to 33%, among the highest in Europe.

Childhood overweight and obesity are chronic diseases, with low rate of resolution either spontaneous or following medical care, and with high rates of persistence into adulthood as well as worsening and/or relapse after temporary improvements. Thus, prevention is recognized as the most promising strategy to combat the obesity epidemic during childhood.

The meta-analysis of pediatric prevention trials has highlighted a poor effectiveness of interventions targeting school children and a scarcity of data on interventions targeting the infancy. This is internationally recognized as an important gap of the state of the art on obesity prevention. In fact, the mechanisms leading to obesity may be triggered, in most children, during the first months or years of life, making preventive interventions too late and non effective for several children who are already overweight or obese at three years of age. The few existing prevention trials targeting pre-school children have been more encouraging than those concerning school-age, especially when considering interventions based on the education of parents rather than on modifications of extra-family environment (kinder-garden, etc...).

There are several known modifiable risk factors for early growth acceleration, which may inspire potentially effective interventions to prevent overweight and obesity in toddlers. These risk factors concern breast feeding, complementary feeding, nutrition during the first and second year of life, parenting style, feeding practices (i.e. scheduled feeding, responsive feeding, feeding to calm, etc...), and overall lifestyle (active play and sleeping patterns).

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 (Investigator)

入排标准

年龄范围
5 Days 至 14 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age: 37-42 weeks; no perinatal complication; informed consent from parents.

排除标准

  • Any congenital disorder, disease or syndrome.

研究组 & 干预措施

Intensive education.

Experimental

Families of newborns whose paediatrician is assigned to the intervention arm, receive standardized lifestyle counseling along with educational written material about their child's first two years of life, which corresponds to the experimental treatment.

干预措施: Intensive education (Behavioral)

Control

No Intervention

Families of newborns whose paediatrician is assigned to the control arm, receive usual education about nutrition and lifestyle, during their child's first two years of life.

结局指标

主要结局

Body mass index (BMI) at two years of age.

时间窗: Third year of the study.

Overweight = BMI above 85° percentile of the CDC curves; Obesity = BMI above 95° percentile of the CDC curves.

次要结局

  • Weight/length ratio at one year of age.(Second year of the study.)
  • Beverages at two years of age.(Third year of the study.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudio Maffeis

Professor

Azienda Ospedaliera Universitaria Integrata Verona

研究点 (2)

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