Cardiovascular DiseasesNCT00005175
Coronary Heart Disease Risk Factors in Upwardly Mobile Blacks and Whites
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To evaluate the relation between blood pressure and socioeconomic status, electrolyte intake, obesity and psychosocial factors in Black and white students. Also, to compare blood pressure, cardiovascular risk factors, sodium and potassium excretion in United States Blacks with West African Blacks. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1985to Jun 1990
- 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 evaluate the relation between blood pressure and socioeconomic status, electrolyte intake, obesity and psychosocial factors in Black and white students. Also, to compare blood pressure, cardiovascular risk factors, sodium and potassium excretion in United States Blacks with West African Blacks.
Read the detailed description
BACKGROUND:
Hypertension related diseases are major causes of morbidity and mortality among United States Blacks. Among Blacks and whites, lower levels of education are associated with higher levels of blood pressure, stroke, and coronary heart disease mortality. High levels of blood pressure in United States Blacks compared to United States whites persist even after controlling for education. Furthermore, it has been demonstrated that individuals living in the southeastern part of the United States continue to have higher stroke and coronary heart disease mortality rates than those living in most other areas of the United States. The number of upwardly mobile Blacks, based on education and occupation, has been increasing in the United States yet relatively little is known about the relationships of improvements in socioeconomic status and cardiovascular risk factors, particularly blood pressure. In Africa, for over four decades, hypertension has been regarded as a rare disease among the Black Africans. However, recent evidence from hospital and community based populations suggests that hypertension is the most prevalent cardiovascular disease among Africans and constitutes a major public health problem, particularly in West Africa. Furthermore, stroke is an increasing health problem.
DESIGN NARRATIVE:
In this longitudinal study, the United States students were recruited and followed annually for three years. The African students were followed for two years. At the initial clinic visit blood pressure, heart rate and anthropometric measurements were obtained and questionnaires completed concerning socioeconomic status, family and medical history, dietary practices, and smoking and drinking habits. One out of every four students had blood pressure measurements reassessed. Each participant collected an overnight urine sample for analysis of sodium and potassium. Fifty percent of the population wore a physical activity monitor for two days. Approximately ten percent of the students' families were studied to validate the hypertensive status and medical history of the parent as reported by the students and to assess known cardiovascular risk factors including obesity, smoking, alcohol intake, physical activity, and behavioral factors. Univariate analyses were conducted to assess the association between the dependent variable of blood pressure and each of the independent variables including age, body mass index, height, sodium and potassium. T-tests were used to analyze the dichotomous variables such as sex, race, and geographic location. Stratification was used to examine blood pressure levels for Blacks and whites by socioeconomic status. Multiple regression models were used to determine whether physiological or psychosocial variables were more predictive of cardiovascular risk.
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, Coronary Disease, Hypertension, Heart Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Hypertension, Heart Diseases, 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 startJul 1985
- Study completionJun 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- NCT00005175
- Sponsor's protocol ID
- 1052
- Other IDs
- R29HL039788
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Adams LL, Washburn RA, Haile GT, Kuller LH. Behavioral factors and blood pressure in black college students. J Chronic Dis. 1987;40(2):131-6. doi: 10.1016/0021-9681(87)90064-6.
PubMed 3818866Washburn RA, Adams LL, Haile GT. Physical activity assessment for epidemiologic research: the utility of two simplified approaches. Prev Med. 1987 Sep;16(5):636-46. doi: 10.1016/0091-7435(87)90047-8.
PubMed 3684976Washburn RA, Adams-Campbell LL, Haile GT. Physical activity and high-density lipoprotein cholesterol and subfractions among young black adults. J Natl Med Assoc. 1987 Aug;79(8):843-8.
PubMed 3509873Adams-Campbell LL, Ukoli F, Young MP, Omene J, Nwankwo M, Haile GT, Kuller LH. An epidemiological assessment of blood pressure determinants in an adolescent population of Nigerians. J Hypertens. 1987 Oct;5(5):575-80. doi: 10.1097/00004872-198710000-00011.
PubMed 3429862Hofman A, Adams LL: Blood Pressure and Age: Is Rise of Blood Pressure During Childhood Inevitable? In: Mild Hypertension: From Drug Trials to Practice, Strasser T, Ganten D (Eds), Raven Press, New York, p 257-263, 1987
Adams-Campbell LL, Nwankwo MU, Omene JA, Ukoli FA, Young MP, Haile GT, Kuller LH. Assessment of cardiovascular risk factors in Nigerian students. Arteriosclerosis. 1988 Nov-Dec;8(6):793-6. doi: 10.1161/01.atv.8.6.793.
PubMed 3196223Nwankwo MU, Adams-Campbell LL, Ukoli FA, Olomu IN, Ukoli CO, Ugwu E. Blood pressure in Nigerian college males. J Hum Hypertens. 1990 Apr;4(2):72-3.
PubMed 2338693
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Heart Disease Risk Factors in Upwardly Mobile Blacks and Whites
- ClinicalTrials.gov ID
- NCT00005175
- Acronym / sponsor ID
- 1052
- Conditions
- Cardiovascular Diseases, Coronary Disease, Hypertension, Heart Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1985
- Study completion
- Jun 1990 (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 evaluate the relation between blood pressure and socioeconomic status, electrolyte intake, obesity and psychosocial factors in Black and white students. Also, to compare blood pressure, cardiovascular risk factors, sodium and potassium excretion in United States Blacks with West African Blacks.
Detailed description
BACKGROUND:
Hypertension related diseases are major causes of morbidity and mortality among United States Blacks. Among Blacks and whites, lower levels of education are associated with higher levels of blood pressure, stroke, and coronary heart disease mortality. High levels of blood pressure in United States Blacks compared to United States whites persist even after controlling for education. Furthermore, it has been demonstrated that individuals living in the southeastern part of the United States continue to have higher stroke and coronary heart disease mortality rates than those living in most other areas of the United States. The number of upwardly mobile Blacks, based on education and occupation, has been increasing in the United States yet relatively little is known about the relationships of improvements in socioeconomic status and cardiovascular risk factors, particularly blood pressure. In Africa, for over four decades, hypertension has been regarded as a rare disease among the Black Africans. However, recent evidence from hospital and community based populations suggests that hypertension is the most prevalent cardiovascular disease among Africans and constitutes a major public health problem, particularly in West Africa. Furthermore, stroke is an increasing health problem.
DESIGN NARRATIVE:
In this longitudinal study, the United States students were recruited and followed annually for three years. The African students were followed for two years. At the initial clinic visit blood pressure, heart rate and anthropometric measurements were obtained and questionnaires completed concerning socioeconomic status, family and medical history, dietary practices, and smoking and drinking habits. One out of every four students had blood pressure measurements reassessed. Each participant collected an overnight urine sample for analysis of sodium and potassium. Fifty percent of the population wore a physical activity monitor for two days. Approximately ten percent of the students' families were studied to validate the hypertensive status and medical history of the parent as reported by the students and to assess known cardiovascular risk factors including obesity, smoking, alcohol intake, physical activity, and behavioral factors. Univariate analyses were conducted to assess the association between the dependent variable of blood pressure and each of the independent variables including age, body mass index, height, sodium and potassium. T-tests were used to analyze the dichotomous variables such as sex, race, and geographic location. Stratification was used to examine blood pressure levels for Blacks and whites by socioeconomic status. Multiple regression models were used to determine whether physiological or psychosocial variables were more predictive of cardiovascular risk.
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 18 Feb 2016.
- Background: PubMed 3818866Adams LL, Washburn RA, Haile GT, Kuller LH. Behavioral factors and blood pressure in black college students. J Chronic Dis. 1987;40(2):131-6. doi: 10.1016/0021-9681(87)90064-6.
- Background: PubMed 3684976Washburn RA, Adams LL, Haile GT. Physical activity assessment for epidemiologic research: the utility of two simplified approaches. Prev Med. 1987 Sep;16(5):636-46. doi: 10.1016/0091-7435(87)90047-8.
- Background: PubMed 3509873Washburn RA, Adams-Campbell LL, Haile GT. Physical activity and high-density lipoprotein cholesterol and subfractions among young black adults. J Natl Med Assoc. 1987 Aug;79(8):843-8.
- Background: PubMed 3429862Adams-Campbell LL, Ukoli F, Young MP, Omene J, Nwankwo M, Haile GT, Kuller LH. An epidemiological assessment of blood pressure determinants in an adolescent population of Nigerians. J Hypertens. 1987 Oct;5(5):575-80. doi: 10.1097/00004872-198710000-00011.
- BackgroundHofman A, Adams LL: Blood Pressure and Age: Is Rise of Blood Pressure During Childhood Inevitable? In: Mild Hypertension: From Drug Trials to Practice, Strasser T, Ganten D (Eds), Raven Press, New York, p 257-263, 1987
- Background: PubMed 3196223Adams-Campbell LL, Nwankwo MU, Omene JA, Ukoli FA, Young MP, Haile GT, Kuller LH. Assessment of cardiovascular risk factors in Nigerian students. Arteriosclerosis. 1988 Nov-Dec;8(6):793-6. doi: 10.1161/01.atv.8.6.793.
- Background: PubMed 2338693Nwankwo MU, Adams-Campbell LL, Ukoli FA, Olomu IN, Ukoli CO, Ugwu E. Blood pressure in Nigerian college males. J Hum Hypertens. 1990 Apr;4(2):72-3.
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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 Coronary Disease, 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 18 Feb 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 NCT00005175, which also lists 7 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 18 Feb 2016.