- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05744973
Multi-level Predictors of Structural Racism and Discrimination and Associations With Health and Well-being Across the Life Course in Diverse Families
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jerica Berge, MD
- Phone Number: 612-626-3693
- Email: jberge@umn.edu
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30602
- Recruiting
- University of Georgia
-
Contact:
- Allan Tate
- Email: allan.tate@uga.edu
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Jerica Berge, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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:
- 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 14 years old
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mental health (parent and child)
Time Frame: baseline to 18 months
|
Change in depression scores using Kessler 6
|
baseline to 18 months
|
Dietary intake
Time Frame: baseline to 18 months
|
Change in modified HEI score
|
baseline to 18 months
|
Physical Activity
Time Frame: baseline to 18 months
|
Change in Sedentary Activity and Moderate/Vigorous Physical Activity using Godin Shephard
|
baseline to 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jerica Berge, MD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SRD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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