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Bridging Rural Inclusion for Dietary Guidance and Education (BRIDGE) Study (BRIDGE)

2026年11月10日 更新者:Alaina Pearce、Penn State University

This study will test the acceptability and feasibility of the Wear-IT app for sending healthy eating messages and collecting questionnaires, photos, and videos via smart phone.

研究概览

地位

尚未招聘

条件

详细说明

This study will be observational. Recruitment of 100, 6-10-year-old child-parent dyads from rural Appalachia will use approved advertisements on popular internet sites, mom's groups, Facebook, family-oriented periodicals, online recruiting databases (e.g., Research Match) and paid recruitment (Build Clinical, Meta). Interested parents will complete an initial screening via REDCap to determine if families fit the inclusion and exclusion criteria. Prior to answering screening questions, the parents will be provided with a brief study description. Once parents complete the screening questions, they will be scheduled for an Onboarding videoconference call (e.g., Zoom). At the Onboarding session, a parent will sign a full study Consent form and children will provide written Assent. Parents will then select locations on a map to mark their home address and any locations they commonly shop for foods. Researchers will also help parents install the Wear-IT app on their own smartphone devices and complete a training protocol. After the Onboarding session, parents will complete an online survey on demographic information, parental feeding practices via the Child Feeding Questionnaire and the Family Food Behavior Survey, both of which have been validated. Neighborhood Impact on Kids Study questionnaire will be used to assess family food rules and parents' perception of the neighborhood food environment. Child appetitive traits will be assessed using the Children's Eating Behavior Questionnaire, which has been validated against laboratory food intake. Lastly, parent eating behavior will be assessed using the validated Three Factor Eating Questionnaire. Parents will use the Wear-IT app for three weeks. During the 3-week period, parents will receive ecological momentary assessment (EMA) prompts and just-in-time adaptive intervention messages related to the three primary diet-related health behavior categories: 1) home food environment; 2) home meals; and 3) food shopping. Specifically, participants will complete weekly home food inventories and meal videos, at-home meal surveys 3 times a week, and daily end-of-day check-in surveys. They will also be prompted to take a picture of their receipt whenever they go to an identified food shopping location. Parents will rate the acceptability of each of the messages sent via Wear-IT using the Intervention Appropriateness Measure. Upon completion of the 3-week Wear-IT period, parents will repeat the online questionnaire they completed after on-boarding. They will also rate the acceptability and validity of Wear-IT's EMA using the Acceptability of Intervention Measure and the Feasibility of Intervention Measure, respectively.

研究类型

观察性的

注册 (估计的)

100

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。

学习联系方式

  • 姓名:Alaina Pearce, PhD
  • 电话号码:814-863-2120
  • 邮箱:azp271@psu.edu

学习地点

    • Pennsylvania
      • State College、Pennsylvania、美国、16802
        • Penn State University
        • 接触:
          • Alaina Pearce, PhD
          • 电话号码:814-863-2120
          • 邮箱:azp271@psu.edu

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

适合学习的年龄

6年 至 10年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Participants will include children and their parents who live in Appalachia.

描述

Inclusion criteria:

In order to be enrolled, children must:

  • Speak fluent English
  • Be of good health based on parental self-report
  • have no learning (e.g., dyslexia) or neurodevelopmental disabilities (e.g., ADHD)
  • between the ages of 6-10 years-old at enrollment.
  • Live in the Appalachian region of the United States.

Parents will be included if:

  • Speak fluent English
  • They report being the primary parent responsible for feeding decisions
  • Have a smart-phone device that has an active phone service plan
  • Live in the Appalachian region of the United States.

Exclusion criteria:

Children would be excluded if they:

  • Do not speak fluent English
  • are <6 years old or > 10 years-old at baseline
  • have any of the following: a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions
  • have a pre-existing medical condition such as type I or type II diabetes, rheumatoid arthritis, Cushing's syndrome, Down's syndrome, food allergies, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, or cerebral palsy.
  • Do not live in the Appalachian region of the United States.

Parents will be excluded if:

  • Do not speak fluent English
  • They report not being the primary parent responsible for feeding decisions
  • Does not have a smart-phone device with an active phone service plan
  • Do not live in the Appalachian region of the United States.

Secondary research subjects (other family members who may appear in video and consent to incidental recording): will be excluded if:

• They did not agree to have their identifiable images included in the home meal video

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

  • 观测模型:ECOLOGIC_OR_COMMUNITY
  • 时间观点:PROSPECTIVE

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Intervention Acceptability
大体时间:immediately after the 3-week intervention period

The Acceptability of Intervention Measure will assess the acceptability of the intervention. No summary score/scoring available. Range from Completely disagree to completely agree.

immediately after the 3-week intervention period
Intervention Appropriateness
大体时间:immediately after the 3-week intervention period

The Intervention Appropriateness Measure will asses the appropriateness of the intervention. No summary score/scoring available. Range from Completely disagree to completely agree.

immediately after the 3-week intervention period
Intervention Satisfaction
大体时间:immediately after the 3-week intervention period

The Satisfaction Survey will assess the participants' satisfaction with the intervention. Scored from 1 (Not at all) to 5 (Absolutely).

immediately after the 3-week intervention period
Intervention Feasibility
大体时间:immediately after the 3-week intervention period

The Feasibility of Intervention Measure will assess participants' perception of the feasibility of this type of intervention. No summary score/scoring available. Range from Completely disagree to completely agree.

immediately after the 3-week intervention period
Daily appropriateness of messages
大体时间:end of each intervention day at time chosen by participant

Ecological momentary assessment surveys will be completed daily to assess the appropriateness of each intervention message received that day. No summary score/scoring available. Range from Completely disagree to completely agree.

end of each intervention day at time chosen by participant

其他结果措施

结果测量
措施说明
大体时间
Home Food Environment
大体时间:Once each week of the 3-week intervention period on a day chosen by parents

Fulkerson Home Food Environment survey will be complete weekly for the 3 weeks of the study to assess types of food available in the home

Once each week of the 3-week intervention period on a day chosen by parents
Child Eating Behaviors
大体时间:Once each week of the 3-week intervention period on a day chosen by parents

Video recordings of children eating at home will be coded to extract various child eating behavior metrics such as bite rate.

Once each week of the 3-week intervention period on a day chosen by parents
Home Meal Information
大体时间:end of day after receipt of intervention messaging throughout the day

As part of a daily EMA surveys, parent will report on home meal environments and participants in home meals.

end of day after receipt of intervention messaging throughout the day

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。

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)

2026年11月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2029年5月1日

研究注册日期

首次提交

2026年10月16日

首先提交符合 QC 标准的

2026年11月10日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • STUDY00029334
  • 1R03TR005950-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 共享支持信息类型

  • 研究方案
  • 分析代码

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.

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