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History of Changes for Study: NCT03934398
Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
Latest version (submitted June 21, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 29, 2019 None (earliest Version on record)
2 October 10, 2019 Groups and Interventions, Study Status and Outcome Measures
3 October 9, 2020 Study Status
4 March 23, 2021 Study Status
5 March 24, 2022 Study Status
6 June 21, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03934398
Submitted Date:  April 29, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: IRB00196923
Brief Title: Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
Official Title: Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
Secondary IDs: 1R56HL139620 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: April 2019
Overall Status: Recruiting
Study Start: April 10, 2019
Primary Completion: March 2021 [Anticipated]
Study Completion: March 2021 [Anticipated]
First Submitted: April 29, 2019
First Submitted that
Met QC Criteria:
April 29, 2019
First Posted: May 1, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
April 29, 2019
Last Update Posted: May 1, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Johns Hopkins University
Responsible Party: Sponsor
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

The investigators aim to determine the association of dietary intake on cardiovascular disease risk factors among children with overweight and obesity who are being evaluated for elevated blood pressure.

The investigators will also investigate for predictors of vascular function and determine if predictors vary by level of sodium intake.

Detailed Description: This research is being done to determine if the food or salt eaten can cause arteries to be stiffer and/or not work as well and if it can impact blood pressure over a 24-hour period of time. The investigators also want to determine if there are any risk factors or blood tests that can predict how stiff arteries are or how well arteries function. The investigators hope that the information from this study will help the investigators prevent blood pressure-related cardiovascular disease in children. This knowledge could help shape future guidelines on how to best prevent and treat high blood pressure and heart disease in children.
Open or close this module Conditions
Conditions: Prehypertension
Hypertension
Overweight and Obesity
Elevated Blood Pressure
Endothelial Dysfunction
Vascular Stiffness
Sleep
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Cross-Sectional
Biospecimen Retention:
Biospecimen Description:
Enrollment: 60 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
ReNEW Clinical Cohort
Individuals evaluated in the ReNEW Clinic at Johns Hopkins University who join the ReNEW Clinic Cohort Study are eligible for this cross-sectional study. Tests will be done for all participants which includes Cardiovascular Assessments, Actigraphy and Laboratory assessments.
Diagnostic Test: Cardiovascular Assessments
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.

Diagnostic Test: Actigraphy
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep.

Diagnostic Test: Laboratory assessments
Participants will provide blood and urine samples for laboratory assessments.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Arterial stiffness as assessed by Pulse wave velocity
[ Time Frame: 1 day ]

This will be determined from Pulse wave velocity (m/sec) done at the study visit
2. Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)
[ Time Frame: 1 day ]

The Ambulatory Arterial Stiffness Index will be determined from data obtained from vascular measures and during 24-hour ambulatory blood pressure monitoring. Arterial stiffness increases as the regression slope approaches 0 and the AASI approaches 1.
3. Arterial stiffness as assessed by Augmentation Index
[ Time Frame: 1 day ]

The Augmentation Index (measured as a percentage) will be determined from a vascular assessment and data obtained during 24-hour ambulatory blood pressure monitoring. A greater Augmentation Index represents a stiffer, less compliant vessel.
4. Endothelial function as assessed by Laser Doppler flow perfusion
[ Time Frame: 1 day ]

The percent change in mean blood flow will be determined from Laser Doppler flow perfusion measurements obtained using a heating protocol.
5. Mean Blood pressure (mmHg)
[ Time Frame: 1 day ]

Mean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.
Open or close this module Eligibility
Study Population: Children and young adults up to 22 years of age who have overweight or obesity and elevated blood pressure, and were referred to the ReNEW Clinic for evaluation and treatment of elevated blood pressure.
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age: 22 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Overweight or obese
  • Elevated blood pressure
  • Referred to the ReNEW Clinic at Johns Hopkins University for evaluation and treatment of elevated blood pressure.

Exclusion Criteria:

  • The only children who will not be eligible for inclusion in this study are those who are non-English speaking.
Open or close this module Contacts/Locations
Central Contact Person: Tammy M Brady, M.D., PhD
Telephone: 410.955.2467
Email: tbrady8@jhmi.edu
Central Contact Backup: Gilbert A Horst, B.A., B.S.
Email: ghorst1@jhmi.edu
Study Officials: Tammy M Brady, M.D., PhD.
Principal Investigator
Johns Hopkins University Division of Pediatric Nephrology
Locations: United States, Maryland
Johns Hopkins School of Medicine Division of Pediatric Nephrology
[Recruiting]
Baltimore, Maryland, United States, 21287
Contact:Contact: Tammy M Brady, M.D., PhD 410-955-2467 tbrady8@jhmi.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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