Clinical trial NCT03934398: Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
Official title: Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prehypertension
Hypertension
Overweight and Obesity
Elevated Blood Pressure
Endothelial Dysfunction
Vascular Stiffness
Sleep
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-05-01
Enrollment: 41
Sex: ALL
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Arterial stiffness as assessed by Pulse wave velocity
timeFrame: 1 day
measure: Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)
timeFrame: 1 day
measure: Arterial stiffness as assessed by Augmentation Index
timeFrame: 1 day
measure: Endothelial function as assessed by Laser Doppler flow perfusion
timeFrame: 1 day
measure: Mean Blood pressure (mmHg)
timeFrame: 1 day
Secondary outcomes:
measure: Pediatric Adverse Childhood Events (ACEs) score
timeFrame: 1 day
measure: Children's Emotion Management Scale (CEMS) score
timeFrame: 1 day
measure: Behavior Assessment for Children (BASC) score
timeFrame: 1 day
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine Division of Pediatric Nephrology
state: Maryland
Study officials:
affiliation: Johns Hopkins University Division of Pediatric Nephrology
name: Tammy M Brady, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: