Study Results
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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COMPLETED
37 participants
OBSERVATIONAL
2020-03-11
2022-05-31
Brief Summary
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The investigators will also aim to identify traditional and non traditional predictors of CVD risk among children with MDO.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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BeHealthY Cohort
Children from BeHealthY cohort who are obese/overweight but do not have mood disorders are eligible for this study. The children will be given additional questionnaires to assess emotional/behavioral well being.
Cardiovascular Assessments
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
Actigraphy
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep
Laboratory assessments
Participants will provide blood and urine samples for laboratory assessments.
Emotional/ Behavioural assessments
Emotional /Behavioral well being will be determined by questionnaires: Pediatrics Adverse Childhood Experiences Questionnaire (ACEs Q), Childrens Emotion Management Scale Questionnaire (CEMS) and Behavior Assessment System for Children (BASC)
CHAMPION trial Cohort
Children who are overweight/obese and have severe mental illness, and who have agreed to be contacted for future research.
Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments.
Cardiovascular Assessments
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
Actigraphy
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep
Laboratory assessments
Participants will provide blood and urine samples for laboratory assessments.
Emotional/ Behavioural assessments
Emotional /Behavioral well being will be determined by questionnaires: Pediatrics Adverse Childhood Experiences Questionnaire (ACEs Q), Childrens Emotion Management Scale Questionnaire (CEMS) and Behavior Assessment System for Children (BASC)
Pediatric Medical Psychiatric (PMP) Clinic Cohort
Children from the PMP Clinic who have severe mental illness but healthy weight. Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments.
Cardiovascular Assessments
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
Actigraphy
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep
Laboratory assessments
Participants will provide blood and urine samples for laboratory assessments.
Emotional/ Behavioural assessments
Emotional /Behavioral well being will be determined by questionnaires: Pediatrics Adverse Childhood Experiences Questionnaire (ACEs Q), Childrens Emotion Management Scale Questionnaire (CEMS) and Behavior Assessment System for Children (BASC)
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.
Actigraphy
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep
Laboratory assessments
Participants will provide blood and urine samples for laboratory assessments.
Emotional/ Behavioural assessments
Emotional /Behavioral well being will be determined by questionnaires: Pediatrics Adverse Childhood Experiences Questionnaire (ACEs Q), Childrens Emotion Management Scale Questionnaire (CEMS) and Behavior Assessment System for Children (BASC)
Eligibility Criteria
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Inclusion Criteria
* Enrolled in the CHAMPION Trial and have agreed to be contacted for future studies or children who visit PMP clinic and have MDO and a healthy weight or participants in the Be-HealthY Cohort whose data indicate no history of MDO.
Exclusion Criteria
* Unable to lie supine
* Significant Arrhythmia
* If participant has used vaso-active drugs the morning of the test (tobacco, caffeine decongestants, or asthma medications).
22 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Tammy M Brady, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins School of Medicine Division of Pediatric Nephrology
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00226838
Identifier Type: -
Identifier Source: org_study_id
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