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

NCT03934398 | Completed DMC

• 2 other identifiers: IRB001969231R56HL139620
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehypertension; Hypertension; Overweight and Obesity; Elevated Blood Pressure; Endothelial Dysfunction; Vascular Stiffness; Sleep

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Pediatric Adverse Childhood Events (ACEs) score

  1 day

• Children's Emotion Management Scale (CEMS) score

  1 day

• Behavior Assessment for Children (BASC) score

  1 day

Study Arms (1)

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; Diagnostic Test: Actigraphy; Diagnostic Test: Laboratory assessments; Diagnostic Test: Emotional/Behavioral Assessments

Interventions

Cardiovascular Assessments DIAGNOSTIC_TEST

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

ReNEW Clinical Cohort

Actigraphy DIAGNOSTIC_TEST

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

ReNEW Clinical Cohort

Laboratory assessments DIAGNOSTIC_TEST

Participants will provide blood and urine samples for laboratory assessments.

ReNEW Clinical Cohort

Emotional/Behavioral Assessments DIAGNOSTIC_TEST

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

ReNEW Clinical Cohort

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Overweight or obese
• Elevated blood pressure
• Referred to the ReNEW Clinic at Johns Hopkins University for evaluation and treatment of elevated blood pressure.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins School of Medicine Division of Pediatric Nephrology

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prehypertension; Hypertension; Overweight; Obesity

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Officials

• Tammy M Brady, M.D., PhD.

  Johns Hopkins University Division of Pediatric Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: April 10, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

US (1)