此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Food Introduction for Risk Reduction, Support Tolerance: Behavioral Intervention for Toddler Eating Success (FIRST BITES)

2026年9月30日 更新者：Drew Bird、University of Texas Southwestern Medical Center

FIRST BITES (Food Introduction for Risk Reduction, Support Tolerance: Behavioral Intervention for Toddler Eating Success): A Multi-Site Community-Based Translational Study of Early Peanut and Egg Introduction With Behavioral Reinforcement

The goal of this clinical trial is to evaluate the feasibility, acceptability, perceived safety, and adherence outcomes of FIRST BITES (Food Introduction for Risk Reduction, Support Tolerance: Behavioral Intervention for Toddler Eating Success), a supervised, community-based early peanut introduction model, in caregiver-infant dyads.

The main questions it aims to answer are:

  • Can eligible caregiver-infant dyads be successfully recruited to and retained in community-based peanut introduction events, and do caregivers find the feeding event, educational materials, and intervention approach acceptable?
  • Does education plus structured behavioral reinforcement improve adherence to peanut feeding recommendations, caregiver self-efficacy, and caregiver anxiety related to early peanut introduction compared with education alone?

Researchers will compare education alone with education plus behavioral reinforcement to determine whether behavioral reinforcement supports continued peanut feeding and improves caregiver confidence following peanut introduction.

Participants will:

  • Attend a supervised community-based peanut introduction event.
  • Receive education about early peanut introduction.
  • Be randomized to receive either education alone or education plus behavioral reinforcement following the feeding event.
  • Complete surveys regarding peanut feeding practices, caregiver self-efficacy, anxiety related to peanut introduction, and perceptions of feasibility, acceptability, and safety.
  • Participate in follow-up assessments during the 6-week intervention period and at 3 months after enrollment.
  • Some participants may be invited to complete qualitative interviews regarding barriers and facilitators to early peanut introduction.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
尚未招聘

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
300

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • University of Arkansas for Medical Sciences/Arkansas Children's Research Institute
        • 接触：
    • Connecticut
      • New Haven、Connecticut、美国、06520
    • Texas

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

4个月 至 8个月 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Caregivers:

    • You are 18 years old or older.
    • You are the infant's parent or legal guardian.
    • You are able to give permission for yourself and your infant to participate in the study.
    • You can speak and read English.
    • You are interested in introducing peanut-containing foods to your infant and continuing to feed peanut regularly.
    • You are willing to attend the supervised peanut feeding event and complete study follow-up activities.
    • You are willing to receive study-related reminders and communications by phone, email, or text message.

  • Infants:

    • They are 4 to 8 months old at the time they join the study.
    • They are developmentally ready to safely eat foods by mouth.
    • They have never eaten peanut before.
    • The study team determines that they are an appropriate candidate for supervised peanut introduction.

  • Advisory Panel Participants:

    • You are 18 years of age or older.
    • You are able to provide informed consent.
    • You have experience related to one or more of the following: Community feeding events, Behavioral interventions, Pediatric allergy care, Community medical practice, Implementation or program development, Health equity, Participant recruitment and retention, Community engagement
    • You are willing to participate in a virtual discussion group or feedback session that may be audio recorded.

Exclusion Criteria:

  • Caregiver-Infant Pairs

    • The infant has already eaten peanut.
    • The infant has a known peanut allergy or has been diagnosed with a peanut allergy by a doctor.
    • The infant has had a previous reaction that may have been caused by a peanut allergy.
    • The infant has a diagnosed feeding disorder.
    • The infant has a medical, developmental, or feeding condition that could make peanut introduction unsafe or make it difficult to participate in the study.
    • The caregiver is not the infant's parent or legal guardian.
    • The caregiver is unable or unwilling to provide consent for participation.
    • The caregiver is unable to participate in study activities and follow-up assessments in English.
    • The caregiver or infant has another condition or circumstance that the study doctor believes would make participation unsafe, impractical, or not in their best interest.

  • Advisory Panel Participants:

    • You are unable or unwilling to provide informed consent.
    • You are unable to participate in the virtual discussion group or feedback session.
    • The study team determines that a conflict of interest, role limitation, or other circumstance makes participation inappropriate.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
其他：Education Alone
行为的：Education

Educational materials provide guidance on peanut feeding practices and recommendations for continued peanut consumption following the initial supervised introduction.
其他：Education plus behavioral reinforcement
行为的：Education and Reminders/Supportive Communication

In addition to the supervised community-based peanut introduction event and educational materials, reinforcements will also be added. Behavioral reinforcement may include reminder messages, prompts, and supportive communications intended to encourage adherence to peanut feeding recommendations and increase caregiver confidence with continued peanut introduction.

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Recruitment, Attendance, Retention, Assessment Completion, and Engagement Rates and Feasibility of Intervention Measure (FIM) Scores
大体时间：Recruitment through Week 6 post-community feeding event (end of intervention)

Feasibility will be assessed using recruitment, enrollment, attendance, retention, and engagement metrics, including the number of families expressing interest, screened, eligible, enrolled, attending a community feeding event, completing supervised peanut introduction, randomized, completing the 6-week assessment, and completing the 3-month assessment. Engagement will be assessed using response rates during weekly text-message check-ins among participants assigned to behavioral reinforcement. Feasibility will also be assessed using the Feasibility of Intervention Measure (FIM), a 4-item participant-reported measure. Total scores range from 4 to 20, with higher scores indicating greater perceived feasibility of the intervention.
Recruitment through Week 6 post-community feeding event (end of intervention)
Acceptability of Community Feeding Events and Behavioral Reinforcement Strategy Measured by Acceptability of Intervention Measure (AIM) Scores and Qualitative Interview Findings
大体时间：6 weeks post-community feeding event (end of intervention)

Acceptability will be assessed using the Acceptability of Intervention Measure (AIM) and qualitative caregiver interview data. The AIM will assess caregiver perceptions of the acceptability of the community feeding event and, for participants assigned to the intervention arm, the 6-week behavioral reinforcement text message program. The AIM is a 4-item participant-reported measure with total scores ranging from 4 to 20, with higher scores indicating greater acceptability. Qualitative interviews will assess caregiver perceptions of the acceptability of the community feeding event, educational materials, peanut preparation demonstration, supervised feeding process, behavioral reinforcement strategy, and follow-up procedures. Interview data will be analyzed to identify caregiver-reported barriers, facilitators, perceived strengths, and suggested refinements.
6 weeks post-community feeding event (end of intervention)
Caregiver-Reported Comfort, Staff-Observed Safety Events, Adverse Events, Emergency Medical Interventions, and Safety Concerns During Supervised Peanut Introduction
大体时间：Community feeding event (Day 0), Week 6 post-community feeding event, and Month 3 follow-up.

Perceived safety will be assessed using caregiver-reported comfort with the supervised peanut introduction process, study staff observations during the community feeding event, documentation of observed or reported symptoms and adverse events, emergency medication administration, emergency medical services activation, and caregiver-reported safety concerns. Safety outcomes will be summarized descriptively overall and by study site.
Community feeding event (Day 0), Week 6 post-community feeding event, and Month 3 follow-up.
Caregiver-Reported Peanut Offering, Peanut Ingestion, Feeding Frequency, and Peanut Protein Consumption
大体时间：Baseline, weekly during Weeks 1-6 for participants assigned to behavioral reinforcement, 6 weeks post-community feeding event, and 3 months post-enrollment.

Adherence to ongoing peanut feeding will be assessed using caregiver-reported peanut offering and ingestion. Measures will include whether peanut was offered to the infant, whether the infant ingested peanut, frequency of peanut offering and ingestion, and estimated quantity of peanut protein consumed. Data will be collected at baseline, 6 weeks, and 3 months. For participants assigned to the behavioral reinforcement arm, weekly text-message check-ins during the 6-week intervention period will also be used to assess week-by-week adherence patterns.
Baseline, weekly during Weeks 1-6 for participants assigned to behavioral reinforcement, 6 weeks post-community feeding event, and 3 months post-enrollment.

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Caregiver Self-Efficacy Measured by the PROMIS General Self-Efficacy Scale
大体时间：Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up

Caregiver self-efficacy will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy Scale, a 4-item caregiver-reported measure, and additional study-specific items related to caregiver confidence in introducing and maintaining peanut in the infant's diet. PROMIS General Self-Efficacy Scale total scores range from 4 to 20, with higher scores indicating greater self-efficacy and confidence in managing challenges related to infant peanut introduction and feeding.
Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up
Caregiver Anxiety Measured by PROMIS Caregiver Anxiety Scale Scores
大体时间：Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up

Caregiver anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Caregiver Anxiety Scale, an 8-item caregiver-reported measure. Total scores range from 8 to 40, with higher scores indicating greater anxiety and more severe anxiety symptoms. Scores will be summarized and compared across study assessment time points.
Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
University of Texas Southwestern Medical Center

合作者

合作者

为临床研究提供支持的赞助商以外的组织。这种支持可能包括与资金、设计、实施、数据分析或报告相关的活动。
American College of Allergy, Asthma and Immunology

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 首席研究员：John Bird, MD、University of Texas Southwestern Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2026年10月1日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2027年4月1日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2027年6月30日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2026年9月24日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年9月30日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2026年10月5日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年10月5日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年9月30日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • STU20261350
  • FP00043943 (其他赠款/资助编号：American College of Allergy Asthma and Immunology)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be made available to external researchers. Data sharing will be limited to authorized study personnel at participating sites as necessary for study conduct, safety monitoring, regulatory compliance, and reporting.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Cookie设置

我们使用cookie来确保我们在您的网站上给您最好的体验。有关更多详细信息，请仔细阅读我们的隐私和Cookie政策。...>>>您可以按照政策中的说明，随时通过从网站或计算机中删除Cookie来更改首选项或撤回您的同意。请接受它，然后在下面的“管理设置”部分中勾选相应的框，选择您的偏好。在继续使用本网站的任何部分之前，请仔细阅读我们的服务条款。
«管理设定