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临床试验/NCT02580123
NCT02580123已完成不适用

Smile-Kids: Study on Complementary Feeding Transition

University of Minho0 个研究点目标入组 53 人开始时间: 2012年5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
53
主要终点
Weight of the infant

研究概览

简要总结

The importance of families in the development of infants is well documented. Previous studies found that the prevalence of overweight and obesity is growing concerns in Portugal (Padez, Fernandes, Mourão, Moreira, & Rosado, 2004) and in the world (Ogden et al., 2014). More, there is evidence that habits acquired in early life might track into adulthood (Lien, Lytle, & Klepp, 2001; Lytle, Seifert, Greenstein, & McGovern, 2000; te Velde, Twisk, & Brug, 2007). Therefore, there is a need to lock overweight and obesity in early childhood in order to contribute to health gains during the entire life cycle. The main purpose of this research is to evaluate the impact of an intervention program based on parenting skills and feeding practices, on infant's growth, development and adherence to new foods in early infancy

Methods: 58 infants, 4-12 months from 25 nursery schools participated in this randomized trial and were randomly allocated to intervention and control group. Infant outcomes were performed at baseline and post-intervention and included anthropometry, dietary assessment and temperament. In addition maternal and family outcomes such as anxiety, dietary intake were also assessed at both times.

An intervention program was developed and Implemented according to two terms: educators' training with the researchers and the intervention with parents and infants developed by trained educators. The training program was developed between December 2013 and February 2014, according to the topics of healthy eating and nutrition and development of the infant. The control group received the standard care.

It is expected that this intervention program is able to promote healthy feeding practices to parents and nursery teachers. The results will be disseminated to the stakeholders and policymakers that work closely to the topic of this study. This will include papers' publication, participation in national and international meetings, contributing to the advance of research in this health area.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Months 至 12 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Infants with 4-12 months

排除标准

  • •Infants with disability

研究组 & 干预措施

Experimental group

Experimental

Received the intervention program.

干预措施: Intervention taught by trained educators (Behavioral)

Control group

No Intervention

received the standard care

结局指标

主要结局

Weight of the infant

时间窗: 4 months up to 12 months of age

Weight was measured with no clothes and no shoes, using standardized procedures,

Body Mass Index (BMI) of the infant

时间窗: 4 months up to 12 months of age

BMI was computed as the ratio weight/length2

Length of the infant

时间窗: 4 months up to 12 months of age

Length was measured according to standardized procedures.

次要结局

  • Dietary intake of infants(4 months up to 12 months of age)
  • Temperament of the infant(4 months up to 12 months of age)
  • Family characteristics(4 months up to 12 months of age)

研究者

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

Helena Rafaela Vieira do Rosario

Dr

University of Minho

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