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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Sleep; Prehypertension; Endothelial Dysfunction; Overweight and Obesity; Vascular Stiffness; Elevated Blood Pressure
• Intervention / Treatment: Diagnostic test: Cardiovascular Assessments; Diagnostic test: Actigraphy; Diagnostic test: Laboratory assessments; Diagnostic test: Emotional/Behavioral Assessments

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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins School of Medicine Division of Pediatric Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.; Diagnostic test: Emotional/Behavioral Assessments; Participants and parents will fill out questionnaires for emotional/behavioral assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Tammy M Brady, M.D., PhD., Johns Hopkins University Division of Pediatric Nephrology

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Body Weight; Hypertension; Prehypertension; Overweight
• Other Study ID Numbers: IRB00196923; 1R56HL139620 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No