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

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ClinicalTrials.gov Identifier: NCT03934398
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

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.


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

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


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




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.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Tammy M Brady, M.D., PhD 410.955.2467 tbrady8@jhmi.edu
Contact: Gilbert A Horst, B.A., B.S. ghorst1@jhmi.edu

Locations
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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    tbrady8@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Tammy M Brady, M.D., PhD. Johns Hopkins University Division of Pediatric Nephrology

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03934398    
Other Study ID Numbers: IRB00196923
1R56HL139620 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Overweight
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms