PrehypertensionNCT03934398
Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
An observational study of Prehypertension and Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Prehypertension, Hypertension, Overweight and Obesity
- What is being tested?
- Cardiovascular Assessments, Actigraphy and Laboratory assessments
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Overweight or obese
- Elevated blood pressure
- Referred to the ReNEW Clinic at Johns Hopkins University for evaluation and treatment of elevated blood pressure.
Who cannot join
- The only children who will not be eligible for inclusion in this study are those who are non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine Division of Pediatric Nephrology
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Prehypertension, Hypertension, Overweight and Obesity, Elevated Blood Pressure, Endothelial Dysfunction, Vascular Stiffness
- Being tested
- Cardiovascular Assessments, Actigraphy, Laboratory assessments, Emotional/Behavioral Assessments
- Medical subject headings
- Prehypertension, Hypertension, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular AssessmentsDiagnostic test
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
ActigraphyDiagnostic test
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep.
Laboratory assessmentsDiagnostic test
Participants will provide blood and urine samples for laboratory assessments.
Emotional/Behavioral AssessmentsDiagnostic test
Participants and parents will fill out questionnaires for emotional/behavioral assessments
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cardiovascular Assessments; Diagnostic Test: Actigraphy; Diagnostic Test: Laboratory assessments; Diagnostic Test: Emotional/Behavioral Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness as assessed by Pulse wave velocity
This will be determined from Pulse wave velocity (m/sec) done at the study visit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Secondary outcomes (3)
Pediatric Adverse Childhood Events (ACEs) score
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.
Measured: 1 day
Children's Emotion Management Scale (CEMS) score
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.
Measured: 1 day
Behavior Assessment for Children (BASC) score
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start10 Apr 2019
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Tammy M Brady, M.D., PhD., Principal investigator, Johns Hopkins University Division of Pediatric Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934398
- Sponsor's protocol ID
- IRB00196923
- Other IDs
- 1R56HL139620
- Status last verified
- Jun 2022
- First submitted
- 29 Apr 2019
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be-HealthY: Behavioral Risk Factors for Poor Vascular Health in Youth
- ClinicalTrials.gov ID
- NCT03934398
- Acronym / sponsor ID
- IRB00196923
- Conditions
- Prehypertension, Hypertension, Overweight and Obesity, Elevated Blood Pressure, Endothelial Dysfunction, Vascular Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReNEW Clinical Cohort | – | Diagnostic Test: Cardiovascular Assessments, Diagnostic Test: Actigraphy, Diagnostic Test: Laboratory assessments, Diagnostic Test: Emotional/Behavioral AssessmentsIndividuals 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. |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Overweight or obese
- Elevated blood pressure
- Referred to the ReNEW Clinic at Johns Hopkins University for evaluation and treatment of elevated blood pressure.
Key exclusion criteria (1 listed)
- The only children who will not be eligible for inclusion in this study are those who are non-English speaking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular AssessmentsParticipants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements. | Diagnostic test | ReNEW Clinical Cohort |
| ActigraphyParticipants will wear an actigraph device for 7 days to measure participant's activity and sleep. | Diagnostic test | ReNEW Clinical Cohort |
| Laboratory assessmentsParticipants will provide blood and urine samples for laboratory assessments. | Diagnostic test | ReNEW Clinical Cohort |
| Emotional/Behavioral AssessmentsParticipants and parents will fill out questionnaires for emotional/behavioral assessments | Diagnostic test | ReNEW Clinical Cohort |
Primary outcome
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.
3 secondary outcomes
Pediatric Adverse Childhood Events (ACEs) score
Time frame: 1 day
Children's Emotion Management Scale (CEMS) score
Time frame: 1 day
Behavior Assessment for Children (BASC) score
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammy M Brady, M.D., PhD. principal investigator
Johns Hopkins University Division of Pediatric Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prehypertension and Hypertension, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness as assessed by Pulse wave velocity (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.