Cardiovascular DiseasesNCT00005141
Minneapolis Children's Blood Pressure Study
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine environmental and familial correlates of childhood blood pressure in order to predict elevated blood pressure in young adulthood. Also, to investigate the phenomena of tracking of blood pressure and obesity from childhood to young adulthood. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1977to May 1997
- 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 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To examine environmental and familial correlates of childhood blood pressure in order to predict elevated blood pressure in young adulthood. Also, to investigate the phenomena of tracking of blood pressure and obesity from childhood to young adulthood.
Read the detailed description
BACKGROUND:
Hypertension has been clearly identified as a major risk factor for coronary heart disease and stroke. Hypertension screening and intervention programs for children are based on the concept that high normal blood pressure may be the childhood antecedent of adult hypertension or that blood pressure 'tracks' through childhood, adolescence, and adulthood. Blood pressure tracking has been well established for adults and young adults but results from various studies in children are controversial. At a Symposium on High Blood Pressure in the Young in 1979, it was concluded that there was insufficient information to recommend specific interventions for prepubertal children with blood pressure levels in the upper percentiles of the blood pressure distribution. Studies of longer duration with large population sizes and repeated blood pressure measurements over time were required to determine if blood pressure levels at these young ages were predictive of adult hypertension.
DESIGN NARRATIVE:
In the Spring of 1978 a total of 10,423 children, ages 6-8 were screened. A subsample was invited to join the study of blood pressure measurement. The sample was selected as follows: all children in the top five percent of the initial systolic blood pressure distribution; all children in the bottom five percent of the initial systolic blood pressure distribution; a random sample of one in two of the remaining Black children; a random sample of one in nine of the remaining white children; and all the remaining children of other races. Included were families of about 200 Native American children. Of 2,641 selected children, 878 refused leaving a sample of 1,753. Baseline data on age, race, sex, triceps skinfold thickness, dietary history, urinary sodium and potassium excretion, physiological measures, life event changes, medical history, demographic data and body size measurements of children and their parents were collected at the first home interview conducted between 1978 and 1979. The children were followed twice per year in 1978 to 1980 and 1982 to 1985 for blood pressure and body size. Annual measurements were made of blood pressure, height, weight, skinfold thickness, and body girths. Screenings continued through early 1991 when the cohort was 19-21 years of age.
Several substudies were conducted including the relationship of red blood cell cation transport to essential hypertension, Type A behavior assessments, and familial aggregation of coronary-prone behavior.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1977
- Study completionMay 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005141
- Sponsor's protocol ID
- 1012
- Other IDs
- R01HL019877
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Prineas RJ, Gillum RF and Blackburn H: Possibilities for Primary Prevention of Hypertension. In: Childhood Prevention of Atherosclerosis and Hypertension, Lauer RM, Shekelle RB (Eds). Raven Press, New York, 1980
Prineas RJ, Gillum RF, Horibe H, Hannan PJ. The Minneapolis children's blood pressure study. Part 1: standards of measurement for children's blood pressure. Hypertension. 1980 Jul-Aug;2(4 Pt 2):I18-24. doi: 10.1161/01.hyp.2.4_pt_2.i18. No abstract available.
PubMed 7399635Prineas RJ, Gillum RF, Horibe H, Hannan PJ. The Minneapolis childrn's blood pressure study. Part 2: multiple determinants of children's blood pressure. Hypertension. 1980 Jul-Aug;2(4 Pt 2):I24-8. doi: 10.1161/01.hyp.2.4_pt_2.i24.
PubMed 7399637Gillum RF, Prineas RJ, Palta M, Horibe H. Blood pressure of urban Native American school children. Hypertension. 1980 Nov-Dec;2(6):744-9. doi: 10.1161/01.hyp.2.6.744.
PubMed 7461791Gillum RF, Elmer PJ, Prineas RJ. Changing sodium intake in children. The Minneapolis Children's Blood Pressure Study. Hypertension. 1981 Nov-Dec;3(6):698-703. doi: 10.1161/01.hyp.3.6.698.
PubMed 7298122Gillum RF, Prineas RJ, Horibe H. Maturation vs age: assessing blood pressure by height. J Natl Med Assoc. 1982 Jan;74(1):43-6.
PubMed 7120442Sinaiko AR, Gillum RF, Jacobs DR Jr, Sopko G, Prineas RJ. Renin-angiotensin and sympathetic nervous system activity in grade school children. Hypertension. 1982 Mar-Apr;4(2):299-306. doi: 10.1161/01.hyp.4.2.299. No abstract available.
PubMed 7040228Sinaiko AR, Glasser RJ, Gillum RF, Prineas RJ. Urinary kallikrein excretion in grade school children with high and low blood pressure. J Pediatr. 1982 Jun;100(6):938-40. doi: 10.1016/s0022-3476(82)80522-2. No abstract available.
PubMed 6919582Folsom AR, Prineas RJ. Drinking water composition and blood pressure: a review of the epidemiology. Am J Epidemiol. 1982 Jun;115(6):818-32. doi: 10.1093/oxfordjournals.aje.a113369. No abstract available.
PubMed 7046430Gillum RF, Prineas RJ, Sopko G, Koga Y, Kubicek W, Robitaille NM, Bass J, Sinaiko A. Elevated blood pressure in school children--prevalence, persistence, and hemodynamics: the Minneapolis Children's Blood Pressure Study. Am Heart J. 1983 Feb;105(2):316-22. doi: 10.1016/0002-8703(83)90533-1. No abstract available.
PubMed 6823814Prineas RJ, Jacobs D. Quality of Korotkoff sounds: bell vs diaphragm, cubital fossa vs brachial artery. Prev Med. 1983 Sep;12(5):715-9. doi: 10.1016/0091-7435(83)90229-3.
PubMed 6657637Gillum RF, Prineas RJ, Elmer PJ. Assessing sodium and potassium intake in essential hypertension. Am Heart J. 1984 Mar;107(3):549-55. doi: 10.1016/0002-8703(84)90099-1. No abstract available.
PubMed 6695700Prineas RJ, Gillum RF, Gomez-Marin O: The Determinants of Blood Pressure in Children: The Minneapolis Children's Blood Pressure Study. In: Loggie J, Horan M, Gruskin A, Hohn AR, Dunbar JB, Havlik RJ (Eds), NHLBI Workshop on Juvenile Hypertension, Bethesda, Maryland 1983. New York, Biomedical Information Corporation, 21-35, 1984
Gillum RF, Gomez-Marin O, Prineas RJ. Racial differences in personality, behavior, and family environment in Minneapolis school children. J Natl Med Assoc. 1984 Nov;76(11):1097-105.
PubMed 6502727Gillum RF, Prineas RJ, Gomez-Marin O, Chang PN, Finn S. Recent life events in school children: race, socioeconomic status, and cardiovascular risk factors. The Minneapolis Children's Blood Pressure Study. J Chronic Dis. 1984;37(11):839-51. doi: 10.1016/0021-9681(84)90017-1.
PubMed 6501538
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minneapolis Children's Blood Pressure Study
- ClinicalTrials.gov ID
- NCT00005141
- Acronym / sponsor ID
- 1012
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1977
- Study completion
- May 1997 (actual)
- First posted
- 26 May 2000 (estimated)
- 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.
To examine environmental and familial correlates of childhood blood pressure in order to predict elevated blood pressure in young adulthood. Also, to investigate the phenomena of tracking of blood pressure and obesity from childhood to young adulthood.
Detailed description
BACKGROUND:
Hypertension has been clearly identified as a major risk factor for coronary heart disease and stroke. Hypertension screening and intervention programs for children are based on the concept that high normal blood pressure may be the childhood antecedent of adult hypertension or that blood pressure 'tracks' through childhood, adolescence, and adulthood. Blood pressure tracking has been well established for adults and young adults but results from various studies in children are controversial. At a Symposium on High Blood Pressure in the Young in 1979, it was concluded that there was insufficient information to recommend specific interventions for prepubertal children with blood pressure levels in the upper percentiles of the blood pressure distribution. Studies of longer duration with large population sizes and repeated blood pressure measurements over time were required to determine if blood pressure levels at these young ages were predictive of adult hypertension.
DESIGN NARRATIVE:
In the Spring of 1978 a total of 10,423 children, ages 6-8 were screened. A subsample was invited to join the study of blood pressure measurement. The sample was selected as follows: all children in the top five percent of the initial systolic blood pressure distribution; all children in the bottom five percent of the initial systolic blood pressure distribution; a random sample of one in two of the remaining Black children; a random sample of one in nine of the remaining white children; and all the remaining children of other races. Included were families of about 200 Native American children. Of 2,641 selected children, 878 refused leaving a sample of 1,753. Baseline data on age, race, sex, triceps skinfold thickness, dietary history, urinary sodium and potassium excretion, physiological measures, life event changes, medical history, demographic data and body size measurements of children and their parents were collected at the first home interview conducted between 1978 and 1979. The children were followed twice per year in 1978 to 1980 and 1982 to 1985 for blood pressure and body size. Annual measurements were made of blood pressure, height, weight, skinfold thickness, and body girths. Screenings continued through early 1991 when the cohort was 19-21 years of age.
Several substudies were conducted including the relationship of red blood cell cation transport to essential hypertension, Type A behavior assessments, and familial aggregation of coronary-prone behavior.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 13 May 2016.
- BackgroundPrineas RJ, Gillum RF and Blackburn H: Possibilities for Primary Prevention of Hypertension. In: Childhood Prevention of Atherosclerosis and Hypertension, Lauer RM, Shekelle RB (Eds). Raven Press, New York, 1980
- Background: PubMed 7399635Prineas RJ, Gillum RF, Horibe H, Hannan PJ. The Minneapolis children's blood pressure study. Part 1: standards of measurement for children's blood pressure. Hypertension. 1980 Jul-Aug;2(4 Pt 2):I18-24. doi: 10.1161/01.hyp.2.4_pt_2.i18. No abstract available.
- Background: PubMed 7399637Prineas RJ, Gillum RF, Horibe H, Hannan PJ. The Minneapolis childrn's blood pressure study. Part 2: multiple determinants of children's blood pressure. Hypertension. 1980 Jul-Aug;2(4 Pt 2):I24-8. doi: 10.1161/01.hyp.2.4_pt_2.i24.
- Background: PubMed 7461791Gillum RF, Prineas RJ, Palta M, Horibe H. Blood pressure of urban Native American school children. Hypertension. 1980 Nov-Dec;2(6):744-9. doi: 10.1161/01.hyp.2.6.744.
- Background: PubMed 7298122Gillum RF, Elmer PJ, Prineas RJ. Changing sodium intake in children. The Minneapolis Children's Blood Pressure Study. Hypertension. 1981 Nov-Dec;3(6):698-703. doi: 10.1161/01.hyp.3.6.698.
- Background: PubMed 7120442Gillum RF, Prineas RJ, Horibe H. Maturation vs age: assessing blood pressure by height. J Natl Med Assoc. 1982 Jan;74(1):43-6.
- Background: PubMed 7040228Sinaiko AR, Gillum RF, Jacobs DR Jr, Sopko G, Prineas RJ. Renin-angiotensin and sympathetic nervous system activity in grade school children. Hypertension. 1982 Mar-Apr;4(2):299-306. doi: 10.1161/01.hyp.4.2.299. No abstract available.
- Background: PubMed 6919582Sinaiko AR, Glasser RJ, Gillum RF, Prineas RJ. Urinary kallikrein excretion in grade school children with high and low blood pressure. J Pediatr. 1982 Jun;100(6):938-40. doi: 10.1016/s0022-3476(82)80522-2. No abstract available.
- Background: PubMed 7046430Folsom AR, Prineas RJ. Drinking water composition and blood pressure: a review of the epidemiology. Am J Epidemiol. 1982 Jun;115(6):818-32. doi: 10.1093/oxfordjournals.aje.a113369. No abstract available.
- Background: PubMed 6823814Gillum RF, Prineas RJ, Sopko G, Koga Y, Kubicek W, Robitaille NM, Bass J, Sinaiko A. Elevated blood pressure in school children--prevalence, persistence, and hemodynamics: the Minneapolis Children's Blood Pressure Study. Am Heart J. 1983 Feb;105(2):316-22. doi: 10.1016/0002-8703(83)90533-1. No abstract available.
- Background: PubMed 6657637Prineas RJ, Jacobs D. Quality of Korotkoff sounds: bell vs diaphragm, cubital fossa vs brachial artery. Prev Med. 1983 Sep;12(5):715-9. doi: 10.1016/0091-7435(83)90229-3.
- Background: PubMed 6695700Gillum RF, Prineas RJ, Elmer PJ. Assessing sodium and potassium intake in essential hypertension. Am Heart J. 1984 Mar;107(3):549-55. doi: 10.1016/0002-8703(84)90099-1. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005141, which also lists 39 linked publications.
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 13 May 2016.