Disentangling the Role of Culture, Life Stage, and Information Design to Facilitate Equity in Data Report Back
2 other identifiers
interventional
1,546
1 country
1
Brief Summary
There remains a need for novel research that facilitates RBRR in a manner that raises data and environmental health literacy (D/EHL) and supports communities striving for environmental health and structural change. Rooted in bioethics and building upon trusted and established long-term partnerships and leveraging existing datasets, the project goal is to create and pilot a national model of report back that is centered in the margins and engages diverse rural and urban EJ communities to ensure that RBRR reaches all populations in a manner tailored to their individual needs, including culture, life stage, language, and design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2024
CompletedFirst Posted
Study publicly available on registry
December 11, 2024
CompletedStudy Start
First participant enrolled
February 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 8, 2025
April 1, 2025
3.2 years
November 25, 2024
April 4, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
Changes from baseline in the mean literacy and numeracy based on questionnaire responses.
Likert scale where one is equivalent to "Disagree Very Strongly" and six is Agree Very Strongly.
From enrollment to the end of treatment at 78 weeks
Changes from baseline in the mean knowledge and awareness risks based on questionnaire responses.
Likert scale where one is equivalent to "Disagree Very Strongly" and six is Agree Very Strongly.
From enrollment to the end of treatment at 78 weeks
Changes from baseline in the mean skills and self-efficacy based on questionnaire responses.
Likert scale where one is equivalent to "Disagree Very Strongly" and six is Agree Very Strongly.
From enrollment to the end of treatment at 78 weeks
Changes from baseline in the mean environmental health engagement based on questionnaire responses.
Likert scale where one is equivalent to "Disagree Very Strongly" and six is Agree Very Strongly.
From enrollment to the end of treatment at 78 weeks
Number of participants reporting themes related to literacy and numeracy.
This is a qualitative analysis; words will be coded and analyzed to identify themes and sentiment's that arise in individual interviews and across all interviews and focus groups.
From enrollment to the end of treatment at 78 weeks
Number of participants reporting themes related to knowledge and awareness risks
This is a qualitative analysis; words will be coded and analyzed to identify themes and sentiment's that arise in individual interviews and across all interviews and focus groups.
From enrollment to the end of treatment at 78 weeks
Number of participants reporting themes related to skills and self-efficacy
This is a qualitative analysis; words will be coded and analyzed to identify themes and sentiment's that arise in individual interviews and across all interviews and focus groups.
From enrollment to the end of treatment at 78 weeks
Number of participants reporting themes related to environmental health engagement.
This is a qualitative analysis; words will be coded and analyzed to identify themes and sentiment's that arise in individual interviews and across all interviews and focus groups.
From enrollment to the end of treatment at 78 weeks
Study Arms (9)
adolescence - graphical
ACTIVE COMPARATORadolescence (10\~19 yrs.) that receives a traditional graphical (figures/charts/tables) representation of environmental health/quality data
adolescence - art-infused
ACTIVE COMPARATORadolescence (10\~19 yrs.) that receives an environment art representation of environmental health/quality data
adolescence - geospatial
ACTIVE COMPARATORadolescence (10\~19 yrs.) that receives a geospatial representation of environmental health/quality data
young adults - graphical
ACTIVE COMPARATORyoung adults (18-26 yrs.) that receives a traditional graphical (figures/charts/tables) representation of environmental health/quality data
young adults - art-infused
ACTIVE COMPARATORyoung adults (18-26 yrs.) that receives an environment art representation of environmental health/quality data
young adults - geospatial
ACTIVE COMPARATORyoung adults (18-26 yrs.) that receives a a geospatial representation of environmental health/quality data
adults - graphical
ACTIVE COMPARATORadults (27 yrs.+) that receives a traditional graphical (figures/charts/tables) representation of environmental health/quality data
adults - art-infused
ACTIVE COMPARATORadults (27 yrs.+) that receives an environment art representation of environmental health/quality data
adults - geospatial
ACTIVE COMPARATORadults (27 yrs.+) that receives a geospatial representation of environmental health/quality data
Interventions
Data report back preference by life span.
Eligibility Criteria
You may qualify if:
- Participants should live in Pinal county, Arizona, Gila county, Arizona, and Cuyahoga county, Ohio.
You may not qualify if:
- Individuals living outside of the partnering counties will not be eligible for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arizona
Tucson, Arizona, 85721, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monica D Ramirez-Andreotta, PhD, Environmental Science
University of Arizona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2024
First Posted
December 11, 2024
Study Start
February 21, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
April 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- This project follows a community-first reporting model. Working with community partners, scientific data will be made accessible as soon as possible, and no later than the time of an associated publication or the end of the performance period of the extramural award that generated the data, whichever occurs first. Data will remain in repositories for the length of time congruent with NIH and University of Arizona data sharing policies. The current minimum prescribed by NIH is three years following study closeout.
- Access Criteria
- Public data will be shared congruent with any redistribution restrictions. A de-identification process for HIPAA-compliant data will be initiated, with input from project partners. All data access will be controlled and credentialed, and made available by a data repository only after approval by the research team and community organizations. All data will be deidentified before publishing to data repositories or completing data sharing requests. Individual data-sharing requests will be evaluated to ensure human research participants' protection, rights, and confidentiality. The process for sharing de-identified environmental and survey data (numerical and spatial) will be articulated in the consent process (an opt-in approach). Sharing geospatial information with external partners will be discussed with the team and a policy will be developed that is aligned with community partners policies.
All data generated, including that used to produce both positive and negative study findings, will be preserved. We will develop a tiered approach for sharing metadata, data summaries, and datasets. In partnership with community-based team members, we will develop a process for external researchers to request access to community datasets in a manner consistent with the policies of each partnering organization. Based on discussions with partnering organizations, metadata for datasets may be posted to an external data repository, which will enable external researchers to identify datasets and initiate a data sharing request. All data sharing requests will require approval by the research team and partnering. If approved, then credentialed access will be provided by the appropriate database administrator to the Data Portal, a HIPAA compliant system. Congruent with UArizona and NIH data sharing policies, all de-identified public data will be shared in a publicly accessible data repository.