- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Alaina Pearce, PhD
- Telefoonnummer: 814-863-2120
- E-mail: azp271@psu.edu
Studie Locaties
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Pennsylvania
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State College, Pennsylvania, Verenigde Staten, 16802
- Penn State University
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Contact:
- Alaina Pearce, PhD
- Telefoonnummer: 814-863-2120
- E-mail: azp271@psu.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Participants will include children and their parents who live in Appalachia.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: ECOLOGIC_OR_COMMUNITY
- Tijdsperspectieven: PROSPECTIVE
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Intervention Acceptability
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Home Food Environment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00029334
- 1R03TR005950-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
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