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临床试验/NCT01816516
NCT01816516已完成不适用

Healthy Babies Through Infant Centered Feeding

Michigan State University4 个研究点 分布在 1 个国家目标入组 546 人开始时间: 2010年2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
546
试验地点
4
主要终点
Change from Baseline in Maternal Responsiveness at different time points (e.g., 6 months, 12 months)

研究概览

简要总结

Poor feeding practices during infancy contribute to obesity risk because they interfere with infant feeding self-regulation and appropriate growth patterns as infants transition from human milk and/or formula-based diets to solid foods. The goal of the project is to provide an educational intervention that fosters appropriate maternal responsiveness, feeding styles, and feeding practices via infant-centered feeding.

详细描述

The long-term goal of this integrated project is to contribute to curbing the rising rates of childhood obesity through an effective, multi-component, relationship skill-building and educational intervention that fosters infant-centered feeding to promote appropriate maternal responsiveness, feeding styles, and feeding practices as infants transition to solid foods.

Research Objectives: To evaluate effectiveness of Healthy Babies (HB) compared to the Expanded Food and Nutrition Education Program (EFNEP) at two points in time (when the infant is 6 and 12 months of age) for mothers of infants on maternal responsiveness, feeding style, and feeding practices as infants' transition to solid foods, and to compare infant feeding self-regulation and growth pattern of infants at 6 and 12 months of age between the two groups, HB and EFNEP.

Hypothesis: Compared to mothers of infants who receive traditional EFNEP lessons, mothers who receive HB lessons will achieve an improvement (when the infant is 6 months old that is sustained over time when the infant is 12 months of age) on:

  • Maternal responsiveness (measured by appropriately interpreting and responding to infant cues when transitioning their infants to solid foods on the Parent-Child Interaction-Feeding Scale [PCI-F]).
  • Maternal feeding styles (measured by feeding beliefs and behaviors on the Infant Feeding Styles Questionnaire).
  • Feeding practices (measured by use of appropriate feeding practices when transitioning their infants to solid foods on the PCI-F).

Research Question: How do infants in the HB (intervention) group compare to the infants in the traditional EFNEP group when the infant is 6 and 12 months old on:

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers aged 18 or older with one, two or three children
  • Infants of low-risk births aged birth to 4 months who have not been introduced to solid foods
  • Low income (those who qualify for EFNEP, income at or below 185% - 200% of the federal poverty level)
  • Infants born between 37 and 42 weeks gestational age with birth weight between 5 pounds 8 ounces and 8 pounds 13 ounces

排除标准

  • Male caregivers
  • Mothers and/or infants diagnosed with feeding or eating disorders

结局指标

主要结局

Change from Baseline in Maternal Responsiveness at different time points (e.g., 6 months, 12 months)

时间窗: Change from Baseline in Maternal Responsiveness at 6 months

Change in maternal responsiveness is measured through an Observational measure (mother-infant feeding interaction): Maternal Responsiveness via Parent-Child Interaction-Feeding Scale (PCI-F) (Formerly Nursing Child Assessment of Feeding Scale)

Change in Baseline in Maternal Responsiveness at different time points (6 months and 12 months)

时间窗: Change in Baseline in Maternal Responsiveness at 12 months

Change in Baseline in maternal responsiveness at 12 months is measured via an observational tool: Parent-Child Interaction -Feeding Scale.

次要结局

  • Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)(Change in Baseline in feeding practices at 12 months)

研究者

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

Mildred Horodynski

Professor

Michigan State University

研究点 (4)

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