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临床试验/NCT06898190
NCT06898190已完成不适用

Testing the Feasibility & Fidelity of the Learning Early Infant Feeding Cues (LEIFc) Intervention

Florida State University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2022年4月10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
29
试验地点
1
主要终点
Responsive Infant Feeding

研究概览

简要总结

The reason that we are doing this research is to teach mothers ways to communicate with their baby during feeding. Understanding signals a baby gives helps mothers know when and how much to feed their baby which will help the baby grow in a healthy way.

There are 5 study visits, 1 during pregnancy and 4 after the baby is born. At the first visit participants will watch some videos about feeding babies and be provided with information to read about feeding babies, there is also a questionnaire to complete. After the baby is born, a research team member will come to participants' homes at infant age of 1, 2, 3, and 4 months to videotape an infant feeding session. At the visit when the baby is 2 and 3 months of age, the intervention will occur in which the interventionists will provide coaching about responsive feeding before and during a feeding session. The baby's height and weight will be collected and some questionnaires completed. At the last study visit, a research assistant will ask opened ended questions about the study itself, these questions and participant answers will be audio recorded.

详细描述

3.0 Background* 3.1 and 3.3 Health disparities in pediatric obesity are staggering; Non-Hispanic black and Hispanic children have obesity rates (22.2% and 25.8% respectively) higher than the national average (18.5%) and higher than non-Hispanic white children (14.1%).1,2 Additionally, children of low socioeconomic status (SES) are more likely to have obesity.2,3 These same populations are disproportionately affected by lifelong cardiometabolic conditions that result from obesity such as hypercholesterolemia, hypertension, and type 2 diabetes.4 Children with obesity are also more likely to suffer from mental health disorders (i.e., depression, anxiety) and complications of the pulmonary, orthopedic, and gastrointestinal systems.2,5,6 Lifestyle modifications implemented early in life are key to preventing obesity and the resulting lifelong complications. The first 1,000 days of life, from conception to age two years, is a critical period for development of habits that contribute to one's weight status later in life, such as dietary preferences and behaviors.7-10 Therefore, interventions implemented during the first 1,000 days and targeting infants from high-risk groups have potential to decrease one's obesity risk and address racial/ethnic and socioeconomic health disparities.

Infant feeding practices, which include what and how infants are fed, are one such habit that could be modified to decrease obesity risk.5 Exclusive formula feeding, short duration of breastfeeding when initiated, and early introduction of complementary foods contribute to rapid infant weight gain which, in turn, contributes to higher risk for childhood obesity.11,12 Many initiatives have targeted "what" infants are fed (i.e., promoting breastfeeding and healthy dietary intake) whereas "how" infants are fed is also important, yet understudied.5,8,13,14 The responsive feeding approach is thought to promote the ability to recognize and respond to internal cues of hunger and satiety.13-17 The ability to recognize these internal cues and self-regulate intake in response to physiologic need is associated with healthy weight gain trajectories.13,16 Responsive feeding occurs when a parent (or other caregiver) learns and recognizes the infant's cues of hunger and satiety, and responds promptly to these cues.18 The Dietary Guidelines for Americans recommend responsive feeding.19 Additionally, a recent systematic review found responsive feeding to be associated with healthy growth in children less than two years of age.13 Education on, and promotion of, responsive feeding should begin prenatally and evolve with the development of the child.18 Infant feeding during the first months after birth often occurs in the home, making this an ideal environment to promote responsive feeding.10,20-22 Interventions to promote responsive feeding have shown benefit in preventing rapid infant weight gain and promoting healthy dietary patterns in young children.20-28 However, this research has not been integrated using a validated coaching approach with the family's home. Additionally, responsive feeding has been largely measured via surveys.25 To address these gaps, an individualized responsive feeding coaching intervention, Learning Early Infant Feeding Cues (LEIFc), has been developed by the PI of the proposed study and her team.

The multicomponent LEIFc intervention involves maternal education on responsive feeding practices while using a family-guided caregiver coaching approach called SS-OO-PP-RR (Setting the Stage, Observation and Opportunities, Problem Solving and Planning, Reflection and Review) during feeding sessions.29,30 The SS-OO-PP-RR approach was developed based on adult learning theory and has been successfully used with parents and childcare providers to promote development across domains in infants and young children.29-31 For the LEIFc intervention, SS-OO-PP-RR was modified to be specific to communication during feeding to promote responsive feeding (Table 1). It is used as a guide for the interventionists during the coaching session but will also be used to evaluate the fidelity of the intervention. The purpose of this study is to test fidelity and feasibility of the LEIFc intervention in a group of diverse mother-infant dyads North Florida.

4.0 Study Endpoints* 4.1 The study will end when the participants complete all time points or the infant reaches 6 months of age.

5.0 Study Intervention

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •pregnant in the 3rd trimester (28 weeks or beyond) of a healthy pregnancy
  • •pregnant with a single fetus
  • •18 years or older
  • •no known complications or genetic anomalies of the infant that would interfere with feeding or growth after birth
  • •English or Spanish speaking

排除标准

  • •mother less than 18 years
  • •will not have custody of the infant after birth

研究组 & 干预措施

LEIFc

Experimental

The LEIFc intervention was developed by the research team and includes several key components, including a prenatal visit to introduce infants' early feeding cues and in the moment coaching supports during feeding routines after the baby is born. The SS-OO-PP-RR ("super," Setting the Stage, Observation and Opportunities, Problem Solving and Planning, Reflection and Review) coaching approach is a hallmark of the intervention that is intended to build caregiver confidence in reading their child's cues with in the moment practice and feedback as well as problem solving and reflecting on what is working or what needs to be adapted.

干预措施: Learning Early Infant Feeding Cues (LEIFc) (Behavioral)

结局指标

主要结局

Responsive Infant Feeding

时间窗: Pre-intervention (infant age 1 month) to post-intervention (infant age 4 months)

Subjective (via survey) and objective (via video) measurement of responsive feeding will be collected pre-post intervention visits. The Infant Feeding Questionnaire will provide a subjective measure of responsive feeding. A feeding session will be video recording then coded for instances of infant cues and maternal response to cues to provide an objective measure of responsive feeding.

次要结局

  • Infant weight-for-length z-score (WLz)(birth to 4 months)
  • Duration of Breastfeeding(weeks since birth)
  • Age of complementary food introduction(weeks since birth)

研究者

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

Jessica Bahorski

Associate Professor

Florida State University

研究点 (1)

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