NCT05744973

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
631

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress71%
Nov 2022Jan 2028

Study Start

First participant enrolled

November 10, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

5.1 years

First QC Date

February 15, 2023

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline to 18 months

Secondary Outcomes (3)

  • Change in Mental health (parent and child)

    baseline to 18 months

  • Dietary intake

    baseline to 18 months

  • Physical Activity

    baseline to 18 months

Interventions

This is an observational study

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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 18 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Georgia

Athens, Georgia, 30602, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Study Officials

  • Jerica Berge, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerica M Berge, PhD, MPH

CONTACT

Jerica Berge, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 27, 2023

Study Start

November 10, 2022

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations