このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

100

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Alaina Pearce, PhD
  • 電話番号:814-863-2120
  • メール:azp271@psu.edu

研究場所

    • Pennsylvania
      • State College、Pennsylvania、アメリカ、16802
        • Penn State University
        • コンタクト:
          • Alaina Pearce, PhD
          • 電話番号:814-863-2120
          • メール:azp271@psu.edu

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6年~10年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:ECOLOGIC_OR_COMMUNITY
  • 時間の展望:PROSPECTIVE

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Intervention Acceptability
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Home Food Environment
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月1日

一次修了 (推定)

2028年5月1日

研究の完了 (推定)

2029年5月1日

試験登録日

最初に提出

2026年10月16日

QC基準を満たした最初の提出物

2026年11月10日

最初の投稿 (実際)

2026年11月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月13日

QC基準を満たした最後の更新が送信されました

2026年11月10日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • STUDY00029334
  • 1R03TR005950-01 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。