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临床试验/NCT02936284
NCT02936284已完成不适用

Enhancing Alternatives to Eating in Infancy

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
2
主要终点
Change in Infant Food Reinforcing Proportion

研究概览

简要总结

This study evaluates the effect of a music enhancement program to strengthen the motivation to engage in music related behaviors rather than eating in infants who are high in motivation to eat. Half the participants will participate in a Music Together Program, while the other half will participate in a Play Date control. For both groups, participants will attend 34 weekly sessions for one year, and 12 monthly sessions the next year, in 6 cohorts.

详细描述

Obesity is a disorder of positive energy balance in which energy intake exceeds energy expenditure. The motivation to eat is a basic human need, which is present at birth. One factor that may lead to increased energy intake is the imbalance between the motivation to eat and the motivation to engage in other behaviors. The motivation to eat versus engaging in other behaviors can be operationalized as the relative reinforcing value of eating versus alternative behaviors.

A strong motivation to eat instead of engaging in alternative behaviors has been related to increased energy intake in adults. The motivation to eat is cross-sectionally and prospectively related to obesity in children, adolescents, and adults, and cross-sectionally related to weight status in infants. Shifting the balance from high motivation to eat to increased motivation to engage in alternative behaviors can reduce energy intake, and may be protective against weight gain.

A structured program to enhance music engagement in infants who are strongly motivated to eat can shift their choice from food to music. This study will expand on this preliminary research and examine long-term effects of this intervention in infants who are highly motivated to eat.

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
Single (Outcomes Assessor)

入排标准

年龄范围
9 Months 至 15 Months(Child)
性别
All
接受健康志愿者

入选标准

  • High food reinforcement

排除标准

  • born preterm (<37 weeks gestation)
  • a low birth weight (< 2500 grams)
  • known developmental delay(s)
  • subject's mother was < 18 years old at the time of pregnancy
  • not yet eating finger foods

结局指标

主要结局

Change in Infant Food Reinforcing Proportion

时间窗: 0-, 3-, 6-, 12-, 24- month

Food reinforcing proportion measures responding for food / total responding for both food and music as a proportion score. Scores range from 0 to 1.0 and higher scores indicate more responding for food than for non-food alternative reinforcer of music. Means reported here are estimated from the mixed-model regression analysis

次要结局

  • Infant 24-Hour Dietary Recall- Change in Energy Intake(0-, 12-, 24- month)
  • Change in Infant Weight-for-length Z-score(0-, 3-, 6-, 12-, 24- month)

研究者

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

Leonard Epstein

Principal Investigator

State University of New York at Buffalo

研究点 (2)

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