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临床试验/NCT02052518
NCT02052518已完成不适用

Early Childhood Obesity Prevention Program: Building Better Families and Communities

Connecticut Children's Medical Center1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2013年6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
57
试验地点
1
主要终点
Number of months of breast feeding

研究概览

简要总结

This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member, 35 group organization whose goal is to improve the health of children in Hartford, CT. In a randomized control trial, the primary aim of this study is to test the initial efficacy of a program of enhanced home visitation with neighborhood and community support to change maternal behaviors related to infant nutrition (sweetened beverage/juice consumption, breastfeeding and introduction of solids), parenting skills (establishing routines around sleep, reading cues for hunger, satiety, television time) and family wellness (improving the home food environment, enhancing physical activity). The investigators hypothesize that at 12 months of age, infants in the intervention arm will drink less sugar sweetened beverages/juices, will have ingested solids at an older age, will have been breastfed longer and more exclusively than infants in the control arm and will have less TV viewing, more established sleep routines and greater soothability (primary outcomes).

详细描述

See Manuscript: 125. Cloutier MM, Wiley J, Wang Z, Grant A, Gorin AA. The Early Childhood Obesity Prevention Program (ECHO): An ecologically-based intervention delivered by home visitors for newborns and their mothers. BMC Public Health, 15:584 PMID 26073106, 2015.

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
None

入排标准

年龄范围
— 至 1 Month(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Enrolled in the Nurturing Families Network Program
  • •Singleton birth >34 weeks gestation
  • •Any race or ethnicity
  • •ECHO neighborhood
  • •Mothers and their newborns

排除标准

  • •Mothers or newborns with special health care needs
  • •Infant with major malformation
  • •Small for Gestational Age/low birth weight

研究组 & 干预措施

Enhanced NFN Home Program

Experimental

Education and Skill set training with materials to implement the behaviors recommended. Using a motivational interviewing framework, intervention participants will receive dietary and activity counseling, develop a Family Wellness Plan and will be linked to community resources.

干预措施: Experimental (Behavioral)

Nurturing Family Network Home Visitation

Placebo Comparator

Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program

干预措施: Experimental (Behavioral)

结局指标

主要结局

Number of months of breast feeding

时间窗: 6 and 12 months

Number of months that child is breastfed

次要结局

未报告次要终点

研究者

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

Michelle Cloutier, MD

Professor of Pediatrics

Connecticut Children's Medical Center

研究点 (1)

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