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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Alaina Pearce, PhD
- Numer telefonu: 814-863-2120
- E-mail: azp271@psu.edu
Lokalizacje studiów
-
-
Pennsylvania
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State College, Pennsylvania, Stany Zjednoczone, 16802
- Penn State University
-
Kontakt:
- Alaina Pearce, PhD
- Numer telefonu: 814-863-2120
- E-mail: azp271@psu.edu
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Participants will include children and their parents who live in Appalachia.
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: ECOLOGIC_OR_COMMUNITY
- Perspektywy czasowe: PROSPECTIVE
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Intervention Acceptability
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Home Food Environment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- STUDY00029334
- 1R03TR005950-01 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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