Cardiovascular DiseasesNCT00005680
Whitehall II - Social and Occupational Influences On Health and Illness
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine the effect on health and disease of the work environment, psychological workload, control over work pacing and content, opportunity for use of skills, social support at work; the moderating effect on these relationships of social supports; and, the interaction between these psychosocial factors and other… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1993to Aug 2007
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To examine the effect on health and disease of the work environment, psychological workload, control over work pacing and content, opportunity for use of skills, social support at work; the moderating effect on these relationships of social supports; and, the interaction between these psychosocial factors and other established risk factors in the etiology of chronic disease.
Read the detailed description
BACKGROUND:
One of the major health problems facing industrialized countries is the persisting social class differences in the rate of occurrence of the major chronic diseases. It is true in the United States as it is in the United Kingdom, Scandinavia, Japan, and other countries. The advantage of investigating these social differences in the United Kingdom is that they have been most extensively documented, but findings are likely to be generalizable. The Black Report comprehensively reviewed the persisting social inequalities in health and concluded that the reasons were not completely understood. The Whitehall Study of the British civil service confirms the social gradient in mortality.
In the British civil service studies, as in the country as a whole, social class is defined on the basis of occupation. This raises the question as to whether the observed differences in morbidity and mortality are due to factors related to occupation or the general way of life. In many countries there are well documented social class differences in aspects of life-style: smoking, leisure-time physical activity, obesity, diet. Such differences were confirmed in civil servants studies, but these were insufficient to account for differences in mortality. There are thus two types of question: what accounts for the differences in smoking and other aspects of life style among men and women in different occupations? and; to what extent may the unexplained social differences in disease rates be related to factors associated with work as distinct from way of life?
DESIGN NARRATIVE:
There was a cross-sectional study and a short-term longitudinal study linking baseline data with morbidity based on sickness-absence records collected over an eighteen month period. Each subject was screened in an on-site work clinic. Questions were included on birthdate, civil service grade, marital status, family history of cardiovascular disease, occupation, car and house ownership, ethnicity, medical history of cardiovascular and respiratory problems, smoking, coffee and alcohol use, dietary intake, physical activity, work characteristics, social support, life satisfaction, life events, and mental illness. Type A behavior was assessed by the Framingham Type A Scale. A separately funded physical exam was conducted and included data on blood pressure, height, weight, pulse, ECG, blood clotting factors, and serum cholesterol. Initial analysis included calculation of prevalence rates of ischemic heart disease by age, sex, and social class as measured by employment grade. Dependent variables were crosstabulated for various categories of independent variables. The independent variables consisted of measures of psychosocial stress arising from work and personal situations.
The study was renewed in 1993 and again in 1997 to continue the follow-up of the cohort and collect further outcome data. This was achieved by 1) continued collection of sickness absence data; 2) obtaining information from GP's regarding long spells of absence; 3) obtaining death certificates and cancer registrations; and 4) a repeat questionnaire to all 10,314 participants to ensure completeness of outcome data. With additional outcome data the investigators used their extensive exposure database to explain the socio-economic gradient in health, encompassing both external influences and biomedical mechanisms. The main focus of the analysis was the role of work stress and social supports and networks both in explaining differences in health between socio-economic groups and individual differences in health. The analysis of these individual differences in health paid particular attention to women and ethnic minorities.
The study was renewed in 2002 to :(1) determine the extent to which socio-economic position and psychosocial factors influence pathophysiological responses and sub-clinical vascular disease directly and via health related behaviors, (2) examine psychosocial explanations for socio-economic differences in coronary health in an occupational cohort moving out of work, (3) determine, in our aging population, the relationships between socio-economic position, coronary disease and health functioning and disability.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Ischemia, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Ischemia, Hypertension
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 1993
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (113)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
- Investigators
- Michael Marmot, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005680
- Sponsor's protocol ID
- 1070
- Other IDs
- R01HL036310
- Status last verified
- Jan 2008
- First submitted
- 25 May 2000
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Stansfeld S, Marmot M. Deriving a survey measure of social support: the reliability and validity of the Close Persons Questionnaire. Soc Sci Med. 1992 Oct;35(8):1027-35. doi: 10.1016/0277-9536(92)90242-i.
PubMed 1411697Stansfeld SA, Marmot MG. Social class and minor psychiatric disorder in British Civil Servants: a validated screening survey using the General Health Questionnaire. Psychol Med. 1992 Aug;22(3):739-49. doi: 10.1017/s0033291700038186.
PubMed 1410098Pilgrim JA, Stansfeld S, Marmot M. Low blood pressure, low mood? BMJ. 1992 Jan 11;304(6819):75-8. doi: 10.1136/bmj.304.6819.75.
PubMed 1737142Marmot MG, Smith GD, Stansfeld S, Patel C, North F, Head J, White I, Brunner E, Feeney A. Health inequalities among British civil servants: the Whitehall II study. Lancet. 1991 Jun 8;337(8754):1387-93. doi: 10.1016/0140-6736(91)93068-k.
PubMed 1674771Rael EG, Stansfeld SA, Shipley M, Head J, Feeney A, Marmot M. Sickness absence in the Whitehall II study, London: the role of social support and material problems. J Epidemiol Community Health. 1995 Oct;49(5):474-81. doi: 10.1136/jech.49.5.474.
PubMed 7499989Marmot M, Feeney A, Shipley M, North F, Syme SL. Sickness absence as a measure of health status and functioning: from the UK Whitehall II study. J Epidemiol Community Health. 1995 Apr;49(2):124-30. doi: 10.1136/jech.49.2.124.
PubMed 7798038Stansfeld S, Feeney A, Head J, Canner R, North F, Marmot M. Sickness absence for psychiatric illness: the Whitehall II Study. Soc Sci Med. 1995 Jan;40(2):189-97. doi: 10.1016/0277-9536(94)e0064-y.
PubMed 7899931Roberts R, Brunner E, White I, Marmot M. Gender differences in occupational mobility and structure of employment in the British Civil Service. Soc Sci Med. 1993 Dec;37(12):1415-25. doi: 10.1016/0277-9536(93)90175-4.
PubMed 8303325Brunner EJ, Marmot MG, White IR, O'Brien JR, Etherington MD, Slavin BM, Kearney EM, Smith GD. Gender and employment grade differences in blood cholesterol, apolipoproteins and haemostatic factors in the Whitehall II study. Atherosclerosis. 1993 Sep;102(2):195-207. doi: 10.1016/0021-9150(93)90162-n.
PubMed 8251006Stansfeld SA, Smith GD, Marmot M. Association between physical and psychological morbidity in the Whitehall II Study. J Psychosom Res. 1993 Apr;37(3):227-38. doi: 10.1016/0022-3999(93)90031-a.
PubMed 8478817Marmot MG, North F, Feeney A, Head J. Alcohol consumption and sickness absence: from the Whitehall II study. Addiction. 1993 Mar;88(3):369-82. doi: 10.1111/j.1360-0443.1993.tb00824.x.
PubMed 8461854North F, Syme SL, Feeney A, Head J, Shipley MJ, Marmot MG. Explaining socioeconomic differences in sickness absence: the Whitehall II Study. BMJ. 1993 Feb 6;306(6874):361-6. doi: 10.1136/bmj.306.6874.361.
PubMed 8461681Marmot M. Social determinants of health: from observation to policy. Med J Aust. 2000 Apr 17;172(8):379-82. doi: 10.5694/j.1326-5377.2000.tb124011.x.
PubMed 10840490Kumari M, Brunner E, Fuhrer R. Minireview: mechanisms by which the metabolic syndrome and diabetes impair memory. J Gerontol A Biol Sci Med Sci. 2000 May;55(5):B228-32. doi: 10.1093/gerona/55.5.b228.
PubMed 10819309Fuhrer R, Head J, Marmot MG. Social position, age, and memory performance in the Whitehall II Study. Ann N Y Acad Sci. 1999;896:359-62. doi: 10.1111/j.1749-6632.1999.tb08141.x. No abstract available.
PubMed 10681922
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whitehall II - Social and Occupational Influences On Health and Illness
- ClinicalTrials.gov ID
- NCT00005680
- Acronym / sponsor ID
- 1070
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Ischemia, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1993
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (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 the effect on health and disease of the work environment, psychological workload, control over work pacing and content, opportunity for use of skills, social support at work; the moderating effect on these relationships of social supports; and, the interaction between these psychosocial factors and other established risk factors in the etiology of chronic disease.
Detailed description
BACKGROUND:
One of the major health problems facing industrialized countries is the persisting social class differences in the rate of occurrence of the major chronic diseases. It is true in the United States as it is in the United Kingdom, Scandinavia, Japan, and other countries. The advantage of investigating these social differences in the United Kingdom is that they have been most extensively documented, but findings are likely to be generalizable. The Black Report comprehensively reviewed the persisting social inequalities in health and concluded that the reasons were not completely understood. The Whitehall Study of the British civil service confirms the social gradient in mortality.
In the British civil service studies, as in the country as a whole, social class is defined on the basis of occupation. This raises the question as to whether the observed differences in morbidity and mortality are due to factors related to occupation or the general way of life. In many countries there are well documented social class differences in aspects of life-style: smoking, leisure-time physical activity, obesity, diet. Such differences were confirmed in civil servants studies, but these were insufficient to account for differences in mortality. There are thus two types of question: what accounts for the differences in smoking and other aspects of life style among men and women in different occupations? and; to what extent may the unexplained social differences in disease rates be related to factors associated with work as distinct from way of life?
DESIGN NARRATIVE:
There was a cross-sectional study and a short-term longitudinal study linking baseline data with morbidity based on sickness-absence records collected over an eighteen month period. Each subject was screened in an on-site work clinic. Questions were included on birthdate, civil service grade, marital status, family history of cardiovascular disease, occupation, car and house ownership, ethnicity, medical history of cardiovascular and respiratory problems, smoking, coffee and alcohol use, dietary intake, physical activity, work characteristics, social support, life satisfaction, life events, and mental illness. Type A behavior was assessed by the Framingham Type A Scale. A separately funded physical exam was conducted and included data on blood pressure, height, weight, pulse, ECG, blood clotting factors, and serum cholesterol. Initial analysis included calculation of prevalence rates of ischemic heart disease by age, sex, and social class as measured by employment grade. Dependent variables were crosstabulated for various categories of independent variables. The independent variables consisted of measures of psychosocial stress arising from work and personal situations.
The study was renewed in 1993 and again in 1997 to continue the follow-up of the cohort and collect further outcome data. This was achieved by 1) continued collection of sickness absence data; 2) obtaining information from GP's regarding long spells of absence; 3) obtaining death certificates and cancer registrations; and 4) a repeat questionnaire to all 10,314 participants to ensure completeness of outcome data. With additional outcome data the investigators used their extensive exposure database to explain the socio-economic gradient in health, encompassing both external influences and biomedical mechanisms. The main focus of the analysis was the role of work stress and social supports and networks both in explaining differences in health between socio-economic groups and individual differences in health. The analysis of these individual differences in health paid particular attention to women and ethnic minorities.
The study was renewed in 2002 to :(1) determine the extent to which socio-economic position and psychosocial factors influence pathophysiological responses and sub-clinical vascular disease directly and via health related behaviors, (2) examine psychosocial explanations for socio-economic differences in coronary health in an occupational cohort moving out of work, (3) determine, in our aging population, the relationships between socio-economic position, coronary disease and health functioning and disability.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- 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 29 Jul 2016.
- Background: PubMed 1411697Stansfeld S, Marmot M. Deriving a survey measure of social support: the reliability and validity of the Close Persons Questionnaire. Soc Sci Med. 1992 Oct;35(8):1027-35. doi: 10.1016/0277-9536(92)90242-i.
- Background: PubMed 1410098Stansfeld SA, Marmot MG. Social class and minor psychiatric disorder in British Civil Servants: a validated screening survey using the General Health Questionnaire. Psychol Med. 1992 Aug;22(3):739-49. doi: 10.1017/s0033291700038186.
- Background: PubMed 1737142Pilgrim JA, Stansfeld S, Marmot M. Low blood pressure, low mood? BMJ. 1992 Jan 11;304(6819):75-8. doi: 10.1136/bmj.304.6819.75.
- Background: PubMed 1674771Marmot MG, Smith GD, Stansfeld S, Patel C, North F, Head J, White I, Brunner E, Feeney A. Health inequalities among British civil servants: the Whitehall II study. Lancet. 1991 Jun 8;337(8754):1387-93. doi: 10.1016/0140-6736(91)93068-k.
- Background: PubMed 7499989Rael EG, Stansfeld SA, Shipley M, Head J, Feeney A, Marmot M. Sickness absence in the Whitehall II study, London: the role of social support and material problems. J Epidemiol Community Health. 1995 Oct;49(5):474-81. doi: 10.1136/jech.49.5.474.
- Background: PubMed 7798038Marmot M, Feeney A, Shipley M, North F, Syme SL. Sickness absence as a measure of health status and functioning: from the UK Whitehall II study. J Epidemiol Community Health. 1995 Apr;49(2):124-30. doi: 10.1136/jech.49.2.124.
- Background: PubMed 7899931Stansfeld S, Feeney A, Head J, Canner R, North F, Marmot M. Sickness absence for psychiatric illness: the Whitehall II Study. Soc Sci Med. 1995 Jan;40(2):189-97. doi: 10.1016/0277-9536(94)e0064-y.
- Background: PubMed 8303325Roberts R, Brunner E, White I, Marmot M. Gender differences in occupational mobility and structure of employment in the British Civil Service. Soc Sci Med. 1993 Dec;37(12):1415-25. doi: 10.1016/0277-9536(93)90175-4.
- Background: PubMed 8251006Brunner EJ, Marmot MG, White IR, O'Brien JR, Etherington MD, Slavin BM, Kearney EM, Smith GD. Gender and employment grade differences in blood cholesterol, apolipoproteins and haemostatic factors in the Whitehall II study. Atherosclerosis. 1993 Sep;102(2):195-207. doi: 10.1016/0021-9150(93)90162-n.
- Background: PubMed 8478817Stansfeld SA, Smith GD, Marmot M. Association between physical and psychological morbidity in the Whitehall II Study. J Psychosom Res. 1993 Apr;37(3):227-38. doi: 10.1016/0022-3999(93)90031-a.
- Background: PubMed 8461854Marmot MG, North F, Feeney A, Head J. Alcohol consumption and sickness absence: from the Whitehall II study. Addiction. 1993 Mar;88(3):369-82. doi: 10.1111/j.1360-0443.1993.tb00824.x.
- Background: PubMed 8461681North F, Syme SL, Feeney A, Head J, Shipley MJ, Marmot MG. Explaining socioeconomic differences in sickness absence: the Whitehall II Study. BMJ. 1993 Feb 6;306(6874):361-6. doi: 10.1136/bmj.306.6874.361.
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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.
Michael Marmot
University of London
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 29 Jul 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 NCT00005680, which also lists 113 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 29 Jul 2016.