- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Alaina Pearce, PhD
- Puhelinnumero: 814-863-2120
- Sähköposti: azp271@psu.edu
Opiskelupaikat
-
-
Pennsylvania
-
State College, Pennsylvania, Yhdysvallat, 16802
- Penn State University
-
Ottaa yhteyttä:
- Alaina Pearce, PhD
- Puhelinnumero: 814-863-2120
- Sähköposti: azp271@psu.edu
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Participants will include children and their parents who live in Appalachia.
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: ECOLOGIC_OR_COMMUNITY
- Aikanäkymät: PROSPECTIVE
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Intervention Acceptability
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Home Food Environment
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- STUDY00029334
- 1R03TR005950-01 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- ANALYTIC_CODE
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .