Education, HealthNCT06729775
Disentangling the Role of Culture, Life Stage, and Information Design to Facilitate Equity in Data Report Back
A study testing Data report back preference by life span in people with Education, Health, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education, Health
- What is being tested?
- Data report back preference by life span
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,546 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants should live in Pinal county, Arizona, Gila county, Arizona, and Cuyahoga county, Ohio.
Who cannot join
- Individuals living outside of the partnering counties will not be eligible for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85721
About this study
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.
Read the 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.
- Conditions
- Education, Health
- Being tested
- Data report back preference by life span
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data report back preference by life spanOther
Data report back preference by life span.
| Study group | Role | What they receive |
|---|---|---|
| adolescence - graphical | Active comparator | adolescence (10~19 yrs.) that receives a traditional graphical (figures/charts/tables) representation of environmental health/quality data Receives: Other: Data report back preference by life span |
| adolescence - art-infused | Active comparator | adolescence (10~19 yrs.) that receives an environment art representation of environmental health/quality data Receives: Other: Data report back preference by life span |
| adolescence - geospatial | Active comparator | adolescence (10~19 yrs.) that receives a geospatial representation of environmental health/quality data Receives: Other: Data report back preference by life span |
| young adults - graphical | Active comparator | young adults (18-26 yrs.) that receives a traditional graphical (figures/charts/tables) representation of environmental health/quality data Receives: Other: Data report back preference by life span |
| young adults - art-infused | Active comparator | young adults (18-26 yrs.) that receives an environment art representation of environmental health/quality data Receives: Other: Data report back preference by life span |
| young adults - geospatial | Active comparator | young adults (18-26 yrs.) that receives a a geospatial representation of environmental health/quality data Receives: Other: Data report back preference by life span |
| adults - graphical | Active comparator | adults (27 yrs.+) that receives a traditional graphical (figures/charts/tables) representation of environmental health/quality data Receives: Other: Data report back preference by life span |
| adults - art-infused | Active comparator | adults (27 yrs.+) that receives an environment art representation of environmental health/quality data Receives: Other: Data report back preference by life span |
| adults - geospatial | Active comparator | adults (27 yrs.+) that receives a geospatial representation of environmental health/quality data Receives: Other: Data report back preference by life span |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start21 Feb 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, HealthStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Monica D Ramirez-Andreotta, PhD, Environmental Science, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729775
- Sponsor's protocol ID
- STUDY00004829
- Other IDs
- R01ES036236
- Status last verified
- Apr 2025
- First submitted
- 25 Nov 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disentangling the Role of Culture, Life Stage, and Information Design to Facilitate Equity in Data Report Back
- ClinicalTrials.gov ID
- NCT06729775
- Acronym / sponsor ID
- STUDY00004829
- Conditions
- Education, Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,546 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| adolescence - graphical | Active comparator | Other: Data report back preference by life spanadolescence (10~19 yrs.) that receives a traditional graphical (figures/charts/tables) representation of environmental health/quality data |
| adolescence - art-infused | Active comparator | Other: Data report back preference by life spanadolescence (10~19 yrs.) that receives an environment art representation of environmental health/quality data |
| adolescence - geospatial | Active comparator | Other: Data report back preference by life spanadolescence (10~19 yrs.) that receives a geospatial representation of environmental health/quality data |
| young adults - graphical | Active comparator | Other: Data report back preference by life spanyoung adults (18-26 yrs.) that receives a traditional graphical (figures/charts/tables) representation of environmental health/quality data |
| young adults - art-infused | Active comparator | Other: Data report back preference by life spanyoung adults (18-26 yrs.) that receives an environment art representation of environmental health/quality data |
| young adults - geospatial | Active comparator | Other: Data report back preference by life spanyoung adults (18-26 yrs.) that receives a a geospatial representation of environmental health/quality data |
| adults - graphical | Active comparator | Other: Data report back preference by life spanadults (27 yrs.+) that receives a traditional graphical (figures/charts/tables) representation of environmental health/quality data |
| adults - art-infused | Active comparator | Other: Data report back preference by life spanadults (27 yrs.+) that receives an environment art representation of environmental health/quality data |
| adults - geospatial | Active comparator | Other: Data report back preference by life spanadults (27 yrs.+) that receives a geospatial representation of environmental health/quality data |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants should live in Pinal county, Arizona, Gila county, Arizona, and Cuyahoga county, Ohio.
Key exclusion criteria (1 listed)
- Individuals living outside of the partnering counties will not be eligible for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data report back preference by life spanData report back preference by life span. | Other | adolescence - art-infused, adolescence - geospatial, adolescence - graphical, adults - art-infused, adults - geospatial, adults - graphical, young adults - art-infused, young adults - geospatial, young adults - graphical |
Primary outcome
Changes from baseline in the mean literacy and numeracy based on questionnaire responses.
Time frame: From enrollment to the end of treatment at 78 weeks
Likert scale where one is equivalent to "Disagree Very Strongly" and six is Agree Very Strongly.
Changes from baseline in the mean knowledge and awareness risks based on questionnaire responses.
Time frame: From enrollment to the end of treatment at 78 weeks
Likert scale where one is equivalent to "Disagree Very Strongly" and six is Agree Very Strongly.
Changes from baseline in the mean skills and self-efficacy based on questionnaire responses.
Time frame: From enrollment to the end of treatment at 78 weeks
Likert scale where one is equivalent to "Disagree Very Strongly" and six is Agree Very Strongly.
Changes from baseline in the mean environmental health engagement based on questionnaire responses.
Time frame: From enrollment to the end of treatment at 78 weeks
Likert scale where one is equivalent to "Disagree Very Strongly" and six is Agree Very Strongly.
Number of participants reporting themes related to literacy and numeracy.
Time frame: From enrollment to the end of treatment at 78 weeks
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.
Number of participants reporting themes related to knowledge and awareness risks
Time frame: From enrollment to the end of treatment at 78 weeks
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.
Number of participants reporting themes related to skills and self-efficacy
Time frame: From enrollment to the end of treatment at 78 weeks
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.
Number of participants reporting themes related to environmental health engagement.
Time frame: From enrollment to the end of treatment at 78 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monica D Ramirez-Andreotta, PhD, Environmental Science principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data report back preference by life span in people with Education, Health, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica D Ramirez-Andreotta, PhD, Environmental Science (520-621-0091, mdramire@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in the mean literacy and numeracy based on questionnaire responses. (time frame: From enrollment to the end of treatment at 78 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.