Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934398
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : June 22, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date April 29, 2019
First Posted Date May 1, 2019
Last Update Posted Date June 22, 2022
Actual Study Start Date April 10, 2019
Actual Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 10, 2019)
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
Official Title Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
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.

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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Prehypertension
  • Hypertension
  • Overweight and Obesity
  • Elevated Blood Pressure
  • Endothelial Dysfunction
  • Vascular Stiffness
  • Sleep
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Diagnostic Test: Cardiovascular Assessments
  • Diagnostic Test: Actigraphy
  • Diagnostic Test: Laboratory assessments
  • Diagnostic Test: Emotional/Behavioral Assessments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 21, 2022)
41
Original Estimated Enrollment
 (submitted: April 29, 2019)
60
Actual Study Completion Date May 31, 2022
Actual Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 22 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03934398
Other Study ID Numbers IRB00196923
1R56HL139620 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Johns Hopkins University
Original Responsible Party Same as current
Current Study Sponsor Johns Hopkins University
Original Study Sponsor Same as current
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Tammy M Brady, M.D., PhD. Johns Hopkins University Division of Pediatric Nephrology
PRS Account Johns Hopkins University
Verification Date June 2022