Skip to main content
OpenTrials
Completed

NCT Number: NCT03934398

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins School of Medicine Division of Pediatric Nephrology

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiovascular Assessments

Diagnostic Test

Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.

Actigraphy

Diagnostic Test

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

Laboratory assessments

Diagnostic Test

Participants will provide blood and urine samples for laboratory assessments.

Emotional/Behavioral Assessments

Diagnostic Test

Participants and parents will fill out questionnaires for emotional/behavioral assessments

Primary outcomes

  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.

Secondary outcomes

  1. Pediatric Adverse Childhood Events (ACEs) score

    Time frame: 1 day

    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.

  2. Children's Emotion Management Scale (CEMS) score

    Time frame: 1 day

    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.

  3. Behavior Assessment for Children (BASC) score

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 1, 2019
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.