Clinical trial NCT06729775: Disentangling the Role of Culture, Life Stage, and Information Design to Facilitate Equity in Data Report Back
Official title: Disentangling the Role of Culture, Life Stage, and Information Design to Facilitate Equity in Data Report Back
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Education, Health
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2024-12-11
Enrollment: 1546
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: The goal of this intervention study is to learn if the data report back design type can modify data and environmental health literacy learning outcomes in adolescence (10\~19 yrs.), young adults (18-26 yrs.) (110), and adults (27 yrs.+).

The main questions it aims to answer are:

* How does design type: (1) graphical (control), art-infused (treatment 1) and geospatial (treatment 2) influence data and environmental health literacy learning outcomes related to numeracy and data literacy?
* How does design type: (1) graphical (control), art-infused (treatment 1) and geospatial (treatment 2) influence data and environmental health literacy learning outcomes related to knowledge and awareness related to environmental risks?
* How does design type: (1) graphical (control), art-infused (treatment 1) and geospatial (treatment 2) influence data and environmental health literacy learning outcomes related to skills and self-efficacy for environmental action?
* How does design type: (1) graphical (control), art-infused (treatment 1) and geospatial (treatment 2) influence data and environmental health literacy learning outcomes related to engaging in environmental health activities?
* \[primary hypothesis or outcome measure 1\]?
* \[primary hypothesis or outcome measure 2\]?

Researchers will compare outcomes related to life span and design type to see if the design type leads to difference data and environmental health literacy learning outcomes by life stage. During analysis, in addition to life stage, participants will also be analyzed by select sociodemographic variables, e.g., income, education, and race/ethnicity.

Participants will be asked to:

* Complete a pre-survey (baseline)
* Complete a post-survey
* Review their randomly assigned repot back design
* Participate in a focus group and answer questions about the design
* At minimum of six months later, participate in an interview

Summary statistics and qualitative summaries of findings will be generated and used to inform interpretation of inferential statistical tests comparing subgroups. Statistical analyses (i.e., Chi square tests, plus Cramér's V, Multivariate analysis of variance (MANOVA), Kruskal-Wallis, and/or Mann-Whitney U tests) will be conducted to determine any significant differences related to (1) numeracy and data literacy, (2) knowledge and awareness related to environmental risks and (3) skills and self-efficacy for environmental action occur by data report back design type and sociodemographic variables.

Eligibility criteria: Inclusion Criteria:

* Participants should live in Pinal county, Arizona, Gila county, Arizona, and Cuyahoga county, Ohio.

Exclusion Criteria:

* Individuals living outside of the partnering counties will not be eligible for participation.

Primary outcomes:
measure: Changes from baseline in the mean literacy and numeracy based on questionnaire responses.
timeFrame: From enrollment to the end of treatment at 78 weeks
measure: Changes from baseline in the mean knowledge and awareness risks based on questionnaire responses.
timeFrame: From enrollment to the end of treatment at 78 weeks
measure: Changes from baseline in the mean skills and self-efficacy based on questionnaire responses.
timeFrame: From enrollment to the end of treatment at 78 weeks
measure: Changes from baseline in the mean environmental health engagement based on questionnaire responses.
timeFrame: From enrollment to the end of treatment at 78 weeks
measure: Number of participants reporting themes related to literacy and numeracy.
timeFrame: From enrollment to the end of treatment at 78 weeks
measure: Number of participants reporting themes related to knowledge and awareness risks
timeFrame: From enrollment to the end of treatment at 78 weeks
measure: Number of participants reporting themes related to skills and self-efficacy
timeFrame: From enrollment to the end of treatment at 78 weeks
measure: Number of participants reporting themes related to environmental health engagement.
timeFrame: From enrollment to the end of treatment at 78 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Monica D Ramirez-Andreotta, PhD, Environmental Science
role: PRINCIPAL_INVESTIGATOR
References: