Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03934398|
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : October 12, 2020
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.
|Condition or disease||Intervention/treatment|
|Prehypertension Hypertension Overweight and Obesity Elevated Blood Pressure Endothelial Dysfunction Vascular Stiffness Sleep||Diagnostic Test: Cardiovascular Assessments Diagnostic Test: Actigraphy Diagnostic Test: Laboratory assessments Diagnostic Test: Emotional/Behavioral Assessments|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth|
|Actual Study Start Date :||April 10, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934398
|Contact: Tammy M Brady, M.D., PhDemail@example.com|
|Contact: Gilbert A Horst, B.A., B.S.||firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins School of Medicine Division of Pediatric Nephrology||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Tammy M Brady, M.D., PhD 410-955-2467 email@example.com|
|Principal Investigator:||Tammy M Brady, M.D., PhD.||Johns Hopkins University Division of Pediatric Nephrology|