- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07937033
Bridging Rural Inclusion for Dietary Guidance and Education (BRIDGE) Study (BRIDGE)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Alaina Pearce, PhD
- Numéro de téléphone: 814-863-2120
- E-mail: azp271@psu.edu
Lieux d'étude
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Pennsylvania
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State College, Pennsylvania, États-Unis, 16802
- Penn State University
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Contact:
- Alaina Pearce, PhD
- Numéro de téléphone: 814-863-2120
- E-mail: azp271@psu.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Participants will include children and their parents who live in Appalachia.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: ECOLOGIC_OR_COMMUNITY
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intervention Acceptability
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Home Food Environment
Délai: Once each week of the 3-week intervention period on a day chosen by parents
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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
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|
Child Eating Behaviors
Délai: Once each week of the 3-week intervention period on a day chosen by parents
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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
Délai: end of day after receipt of intervention messaging throughout the day
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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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00029334
- 1R03TR005950-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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