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

10 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Alaina Pearce, PhD
  • Numero di telefono: 814-863-2120
  • Email: azp271@psu.edu

Luoghi di studio

    • Pennsylvania
      • State College, Pennsylvania, Stati Uniti, 16802
        • Penn State University
        • Contatto:
          • Alaina Pearce, PhD
          • Numero di telefono: 814-863-2120
          • Email: azp271@psu.edu

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 10 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: ECOLOGIC_OR_COMMUNITY
  • Prospettive temporali: PROSPECTIVE

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intervention Acceptability
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Home Food Environment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 maggio 2029

Date di iscrizione allo studio

Primo inviato

16 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 novembre 2026

Primo Inserito (Effettivo)

13 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • STUDY00029334
  • 1R03TR005950-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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