Racially/Ethnically Diverse Families From Urban SettingsNCT05744973
Multi-level Predictors of Structural Racism and Discrimination and Associations With Health and Well-being Across the Life Course in Diverse Families
An observational study of Racially/Ethnically Diverse Families From Urban Settings, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
Minoritized populations face mutually reinforcing levels of structural disadvantage that contribute to poor health. Despite recognition that social and economic stratification, environmental conditions, and policy are critical determinants of health disparities, there has been limited effort in expanding interventions… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Racially/Ethnically Diverse Families From Urban Settings
- How many people
- 631 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2022to 31 Jan 2028
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- Child, Adult
Study population: UMN: The study will be enrolling vulnerable populations, just as it did during the original study. To accommodate for this, children will be assented into the study and all participant materials will be translated into Spanish, Hmong, and Somali. Bilingual staff will be employed and able to assist participants whose reading skills are limited. The study will provide free parking to participants and compensate all participants (both parents and children) for their time spent on study processes. The study will enroll participants who happen to be pregnant and will not seek out pregnant adolescents. UGA: The University of Georgia site will follow the same process to accommodate vulnerable populations.
Who may be able to join
- willingness to provide informed consent (parent/guardian), parental consent (parent/guardian) and assent (minor participants) and the ability for participants to comply with study requirements
- They are the child's primary caregiver, i.e., they are the adult who spends the largest proportion of time caring for the child (e.g., cleaning, feeding, etc.) or they spent an exactly equal proportion to another caregiver (e.g., parents each with 50% of childcare responsibilities).
- They reside in Athens-Clarke County or surrounding counties (i.e., Barrow, Jackson, Madison, Oglethorpe, and Oconee) served by the Piedmont Healthcare Coalition region
- Have access to a smartphone or other internet-connected device (e.g., iPad; home computer; laptop)
- Are able to read either English or Spanish
- UMN site:
Show all 15Show fewer
- participation in the original Family Matters Ecological Momentary Assessment sub-study
- did not withdraw from the Family Matters study
- ability to participate in an in-person visit (e.g., within driving distance to make an in-person visit)
- The original Family Matters study enrolled vulnerable populations including children, pregnant women, disadvantaged persons, and non-English speakers.
- UGA site:
- Child has a racial/ethnic identity reported by the parent as Black, Hispanic, or White Reside in Athens-Clarke County or surrounding counties (i.e., Barrow, Jackson, Madison, Oglethorpe, and Oconee) served by the Piedmont Healthcare Coalition region
- Have access to a smartphone or other internet-connected device (e.g., iPad; home computer; laptop)
- Are able to read either English or Spanish
- Aged 8 to 18 years old
Who cannot join
- Medically necessary dietary restrictions (e.g., feeding tubes)
- BMI < 5%ile
- A diagnosis of a serious and persistent mental illness
- The child's parent/caregiver believes that the child is not developmentally able to participate in study components (e.g., severe autism)
- The family already has one parent or one child enrolled in the study
- There are no more availabilities in the family's census tract (limited to 10 households per tract). UGA also is interested in recruiting families from a range of census tracts in the Athens, GA area. If UGA finds that many families are coming from a few census tracts, they may restrict enrollment of new participants who are from those already-represented census tracts.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jerica Berge, PhD contact
United States2 sites, 2 recruiting
- Recruiting
University of Georgia
Athens, Georgia, 30602
Allan Tate, allan.tate@uga.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Jerica Berge, MD
About this study
Minoritized populations face mutually reinforcing levels of structural disadvantage that contribute to poor health. Despite recognition that social and economic stratification, environmental conditions, and policy are critical determinants of health disparities, there has been limited effort in expanding interventions beyond the individual level to disrupt systemic causes of health. This is in part due to the challenges of describing how racism and discrimination have become systematized over time and across place.68 Studies that do examine SRD and health and well-being, focus on one level of SRD at a time, rather than examining multiple levels simultaneously. Also, the measurement of SRD at all levels has not been very detailed and more research is needed on the nuances of these experiences (e.g., frequency, timeframe, intensity). Finally, there is a need for more prospective longitudinal studies, as most research to date has been cross-sectional. In addition to comprehensively examining the four SRD levels, the current study will examine these multi- level predictors of SRD simultaneously, longitudinally, and across two sites to identify targets for multi-level interventions that will be more likely to be effective and sustainable.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in cardiometabolic risk score
comprised of 5 cardiometabolic indicators of lower health - overweight status, triglyceride to HDL ratio, c-reactive protein , stage 1 or 2 hypertension, and elevated HbA1c \>= 5.7across two time points 18 months apart collected in children and adults
Measured: baseline to 18 months
Secondary outcomes (3)
Change in Mental health (parent and child)
Change in depression scores using Kessler 6
Measured: baseline to 18 months
Dietary intake
Change in modified HEI score
Measured: baseline to 18 months
Physical Activity
Change in Sedentary Activity and Moderate/Vigorous Physical Activity using Godin Shephard
Measured: baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start10 Nov 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Racially/Ethnically Diverse Families From Urban SettingsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 631 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jerica Berge, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744973
- Sponsor's protocol ID
- SRD
- Status last verified
- May 2024
- First submitted
- 15 Feb 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Predictors of Structural Racism and Discrimination and Associations With Health and Well-being Across the Life Course in Diverse Families
- ClinicalTrials.gov ID
- NCT05744973
- Acronym / sponsor ID
- SRD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 631 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 27 Feb 2023 (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.
Minoritized populations face mutually reinforcing levels of structural disadvantage that contribute to poor health. Despite recognition that social and economic stratification, environmental conditions, and policy are critical determinants of health disparities, there has been limited effort in expanding interventions beyond the individual level to disrupt systemic causes of health. This is in part due to the challenges of describing how racism and discrimination have become systematized over time and across place.68 Studies that do examine SRD and health and well-being, focus on one level of SRD at a time, rather than examining multiple levels simultaneously. Also, the measurement of SRD at all levels has not been very detailed and more research is needed on the nuances of these experiences (e.g., frequency, timeframe, intensity). Finally, there is a need for more prospective longitudinal studies, as most research to date has been cross-sectional. In addition to comprehensively examining the four SRD levels, the current study will examine these multi- level predictors of SRD simultaneously, longitudinally, and across two sites to identify targets for multi-level interventions that will be more likely to be effective and sustainable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- UMN: The study will be enrolling vulnerable populations, just as it did during the original study. To accommodate for this, children will be assented into the study and all participant materials will be translated into Spanish, Hmong, and Somali. Bilingual staff will be employed and able to assist participants whose reading skills are limited. The study will provide free parking to participants and compensate all participants (both parents and children) for their time spent on study processes. The study will enroll participants who happen to be pregnant and will not seek out pregnant adolescents. UGA: The University of Georgia site will follow the same process to accommodate vulnerable populations.
Key inclusion criteria (15 listed)
- willingness to provide informed consent (parent/guardian), parental consent (parent/guardian) and assent (minor participants) and the ability for participants to comply with study requirements
- They are the child's primary caregiver, i.e., they are the adult who spends the largest proportion of time caring for the child (e.g., cleaning, feeding, etc.) or they spent an exactly equal proportion to another caregiver (e.g., parents each with 50% of childcare responsibilities).
- They reside in Athens-Clarke County or surrounding counties (i.e., Barrow, Jackson, Madison, Oglethorpe, and Oconee) served by the Piedmont Healthcare Coalition region
- Have access to a smartphone or other internet-connected device (e.g., iPad; home computer; laptop)
- Are able to read either English or Spanish
Key exclusion criteria (6 listed)
- Medically necessary dietary restrictions (e.g., feeding tubes)
- BMI < 5%ile
- A diagnosis of a serious and persistent mental illness
- The child's parent/caregiver believes that the child is not developmentally able to participate in study components (e.g., severe autism)
- The family already has one parent or one child enrolled in the study
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 |
|---|---|---|
| No interventionThis is an observational study | Other | – |
Primary outcome
changes in cardiometabolic risk score
Time frame: baseline to 18 months
comprised of 5 cardiometabolic indicators of lower health - overweight status, triglyceride to HDL ratio, c-reactive protein , stage 1 or 2 hypertension, and elevated HbA1c \>= 5.7across two time points 18 months apart collected in children and adults
3 secondary outcomes
Change in Mental health (parent and child)
Time frame: baseline to 18 months
Dietary intake
Time frame: baseline to 18 months
Physical Activity
Time frame: baseline to 18 months
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 May 2024.
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.
Jerica Berge, PhD contact
Jerica Berge, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Racially/Ethnically Diverse Families From Urban Settings, run by University of Colorado, Denver at 2 sites 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 15 inclusion and 6 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 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jerica M Berge, PhD, MPH (303-724-1938, jerica.berge@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in cardiometabolic risk score (time frame: baseline to 18 months). 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 May 2024.