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

NCT ID: NCT03934398

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-10

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Cardiovascular Assessments

Intervention Type DIAGNOSTIC_TEST

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

Actigraphy

Intervention Type DIAGNOSTIC_TEST

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

Laboratory assessments

Intervention Type DIAGNOSTIC_TEST

Participants will provide blood and urine samples for laboratory assessments.

Emotional/Behavioral Assessments

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Cardiovascular Assessments

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

Intervention Type DIAGNOSTIC_TEST

Actigraphy

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

Intervention Type DIAGNOSTIC_TEST

Laboratory assessments

Participants will provide blood and urine samples for laboratory assessments.

Intervention Type DIAGNOSTIC_TEST

Emotional/Behavioral Assessments

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tammy M Brady, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University Division of Pediatric Nephrology

Locations

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Johns Hopkins School of Medicine Division of Pediatric Nephrology

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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1R56HL139620

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00196923

Identifier Type: -

Identifier Source: org_study_id

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