Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth

Hypertension Clinical Trial

Official title:

Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934398
• Other study ID #: IRB00196923
• Secondary ID: 1R56HL139620
• Status: Completed
• Start date: April 10, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Endothelial Dysfunction
• Hypertension
• Overweight
• Overweight and Obesity
• Prehypertension
• Sleep
• Vascular Stiffness

Intervention

Diagnostic Test:
• Cardiovascular Assessments
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
• Actigraphy
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep.
• Laboratory assessments
Participants will provide blood and urine samples for laboratory assessments.
• Emotional/Behavioral Assessments
Participants and parents will fill out questionnaires for emotional/behavioral assessments

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine Division of Pediatric Nephrology	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness as assessed by Pulse wave velocity	This will be determined from Pulse wave velocity (m/sec) done at the study visit	1 day
Primary	Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)	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.	1 day
Primary	Arterial stiffness as assessed by Augmentation Index	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.	1 day
Primary	Endothelial function as assessed by Laser Doppler flow perfusion	The percent change in mean blood flow will be determined from Laser Doppler flow perfusion measurements obtained using a heating protocol.	1 day
Primary	Mean Blood pressure (mmHg)	Mean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.	1 day
Secondary	Pediatric Adverse Childhood Events (ACEs) score	The Pediatric ACEs questionnaire contains 17 yes or no questions about stressful or traumatic life events. Greater exposure to adverse childhood experiences (ACEs) is associated with poorer physical and mental health. Some researchers have suggested that an ACEs score of greater than or equal to 3 or 4 significantly increases the risk for health problems, however, there is no widely accepted threshold for how many ACEs endorsed is clinically significant or more predictive of these problems.	1 day
Secondary	Children's Emotion Management Scale (CEMS) score	The Children's Emotional management scale is a questionnaire that consists of 33 questions (3 point Likert scale) examining youth's ability to regulate appropriately their negative emotions (i.e. anger, sadness, and worry). Generally, poorer emotion regulation capabilities are associated with poorer health outcomes, with most research looking at CV outcomes in adults.	1 day
Secondary	Behavior Assessment for Children (BASC) score	The Behavior Assessment for Children is a questionnaire that consists of 189 questions (True/False and 4 point Likert scale). It is a broad behavioral screening measure commonly used in child and adolescent psychology and psychiatric settings.It has three primary scales: internalizing (e.g., depression, anxiety), externalizing (e.g., aggression, hyperactivity), and total problems (combination of internalizing and externalizing plus attention problems and withdrawal subscales). Scores between 60-69 are considered "at risk" for clinical problems and scores of 70+ are considered clinically significant presence of those symptoms. Any scores that are not in this range are considered to be within normal limits and not indicative of difficulties.	1 day