NCT03816462

Brief Summary

This is an ongoing, prospective cohort study of children and young adults who are evaluated in the Reversing the Negative Effects of Weight on the Heart (ReNEW) Clinic at Johns Hopkins University. Demographic and clinical data of patients who agree to participate are obtained via chart review and entered into a longitudinal clinic registry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2015

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

11 years

First QC Date

January 22, 2019

Last Update Submit

January 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Demographic and clinical data obtained via chart review

    This is a clinic based registry of cardiovascular disease risk data from participants to be collected over time.

    20 years

Eligibility Criteria

AgeUp to 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children between birth and 22 years of age with overweight or obesity referred for evaluation of elevated blood pressure in the ReNEW Clinic at Johns Hopkins University

You may qualify if:

  • Children and young adults with overweight or obesity referred for evaluation of elevated blood pressure in the ReNEW Clinic at Johns Hopkins University are eligible.

You may not qualify if:

  • Children who are wards of the state or who are non-English speaking without an in-person interpreter accompanying them to the clinic visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

  • Wen W, Psoter KJ, Solomon BS, Urbina EM, Brady TM. Accuracy and Performance of Triage Blood Pressure Measurements in A Real-World Clinic Setting. J Pediatr. 2024 Jun;269:113962. doi: 10.1016/j.jpeds.2024.113962. Epub 2024 Feb 17.

  • Ducharme-Smith K, Brady TM, Vizthum D, Caulfield LE, Mueller NT, Rosenstock S, Garcia-Larsen V. Diet quality scores associated with improved cardiometabolic measures among African American adolescents. Pediatr Res. 2022 Sep;92(3):853-861. doi: 10.1038/s41390-021-01893-w. Epub 2021 Dec 16.

Related Links

MeSH Terms

Conditions

HypertensionPrehypertensionObesityOverweightHypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCardiomegalyHeart DiseasesHypertrophyPathological Conditions, Anatomical

Study Officials

  • Tammy M Brady

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 25, 2019

Study Start

January 1, 2015

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations