CHDNCT00289237
Lifestyle Intervention in a General Population for Prevention of Ischaemic Heart Disease
A study testing Lifestyle intervention in people with CHD and AMI, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61,301 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 1999to Mar 2011
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All citizens in a predefined area
Who cannot join
- Drug abuse
- Language problem
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Centre for Prevention and Health
Glostrup Municipality, 2600
About this study
Official title: A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99
In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results, most probably due to insufficient interventions and methodology.
Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.
Read more
After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.
The status for the project is that the four waves of intervention have been performed, the last follow-up was in March 2006.
Data collection finalized with 10 years follow-up via Central National Registries and a questionnaire. No further follow-up is scheduled for the main purposes of the study.
Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin off project are on-going.
More than 25 Ph.d. studies and more than 200 peer-review publication have so far been produced.
Summary of results, links to articles and theses at: www.Inter99.dk
Read the detailed description
In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results.
Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.
After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.
- Conditions
- CHD, AMI, CVD, Type 2 Diabetes, COLD
- Being tested
- Lifestyle intervention
- Keywords
- Lifestyle intervention, Behavioural changes, CHD, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| High intensity intervention group | Experimental | Lifestyle intervention consisted of 15-30 minutes of individual lifestyle counselling + offer of participation in group-based lifestyle counselling (½ year). This offer was given at baseline to all participants in the group.
Persons at high risk of IHD: offer additionally given at 1- and 3-year follow-up Receives: Behavioral: Lifestyle intervention |
| Low intensity intervention group | Experimental | Lifestyle intervention consisted of 15-30 minutes of individual lifestyle counselling. This offer was given at baseline to all participants in the group.
Persons at high risk of IHD: offer additionally given at 1- and 3-year follow-up Receives: Behavioral: Lifestyle intervention |
| Control group | No intervention | Questionnaires regarding lifestyle and general health were sent to all participants in this group. The importance of healthy lifestyle was not mentioned, and no intervention was offered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CHD and other lifestyle related diseases after ten years
Ongoing analyses in National Central Registers (Oct 2012)
Measured: 2012
Secondary outcomes (1)
Changes in lifestyle and biological markers after one, three and five years
Analyses completed. Results at: www.Inter99.dk
Measured: 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startMar 1999
- Primary completionMar 2006
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for CHDStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61,301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Responsible party
- Principal investigator, Birgitte Pickering, Glostrup University Hospital, Copenhagen
- Investigators
- Torben Jørgensen, DrMedSci, Principal investigator, Research Centre for Prevention and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289237
- Sponsor's protocol ID
- RCPH - 99-1
- Status last verified
- Oct 2012
- First submitted
- 19 Sep 2005
- Last updated
- 3 Oct 2012
- Results posted
- No
Publications
Glumer C, Jorgensen T, Borch-Johnsen K; Inter99 study. Prevalences of diabetes and impaired glucose regulation in a Danish population: the Inter99 study. Diabetes Care. 2003 Aug;26(8):2335-40. doi: 10.2337/diacare.26.8.2335.
PubMed 12882858Husemoen LL, Thomsen TF, Fenger M, Jorgensen HL, Jorgensen T. Contribution of thermolabile methylenetetrahydrofolate reductase variant to total plasma homocysteine levels in healthy men and women. Inter99 (2). Genet Epidemiol. 2003 May;24(4):322-30. doi: 10.1002/gepi.10239.
PubMed 12687650Jorgensen ME, Glumer C, Bjerregaard P, Gyntelberg F, Jorgensen T, Borch-Johnsen K; Grennland Population Study. Obesity and central fat pattern among Greenland Inuit and a general population of Denmark (Inter99): relationship to metabolic risk factors. Int J Obes Relat Metab Disord. 2003 Dec;27(12):1507-15. doi: 10.1038/sj.ijo.0802434.
PubMed 14634682Jorgensen T, Borch-Johnsen K, Thomsen TF, Ibsen H, Glumer C, Pisinger C. A randomized non-pharmacological intervention study for prevention of ischaemic heart disease: baseline results Inter99. Eur J Cardiovasc Prev Rehabil. 2003 Oct;10(5):377-86. doi: 10.1097/01.hjr.0000096541.30533.82.
PubMed 14663300Nielsen EM, Hansen L, Echwald SM, Drivsholm T, Borch-Johnsen K, Ekstrom CT, Hansen T, Pedersen O. Evidence for an association between the Leu162Val polymorphism of the PPARalpha gene and decreased fasting serum triglyceride levels in glucose tolerant subjects. Pharmacogenetics. 2003 Jul;13(7):417-23. doi: 10.1097/01.fpc.0000054105.48725.5c.
PubMed 12835617Glumer C, Carstensen B, Sandbaek A, Lauritzen T, Jorgensen T, Borch-Johnsen K; inter99 study. A Danish diabetes risk score for targeted screening: the Inter99 study. Diabetes Care. 2004 Mar;27(3):727-33. doi: 10.2337/diacare.27.3.727.
PubMed 14988293Glumer C, Jorgensen T, Borch-Johnsen K. Targeted screening for undiagnosed diabetes reduces the number of diagnostic tests. Inter99(8). Diabet Med. 2004 Aug;21(8):874-80. doi: 10.1111/j.1464-5491.2004.01260.x.
PubMed 15270791Hansen SK, Gjesing AP, Rasmussen SK, Glumer C, Urhammer SA, Andersen G, Rose CS, Drivsholm T, Torekov SK, Jensen DP, Ekstrom CT, Borch-Johnsen K, Jorgensen T, McCarthy MI, Hansen T, Pedersen O. Large-scale studies of the HphI insulin gene variable-number-of-tandem-repeats polymorphism in relation to Type 2 diabetes mellitus and insulin release. Diabetologia. 2004 Jun;47(6):1079-87. doi: 10.1007/s00125-004-1418-3. Epub 2004 May 29.
PubMed 15170498Johansen A, Nielsen EM, Andersen G, Hamid YH, Jensen DP, Glumer C, Drivsholm T, Borch-Johnsen K, Jorgensen T, Hansen T, Pedersen O. Large-scale studies of the functional K variant of the butyrylcholinesterase gene in relation to Type 2 diabetes and insulin secretion. Diabetologia. 2004 Aug;47(8):1437-41. doi: 10.1007/s00125-004-1459-7. Epub 2004 Jul 17.
PubMed 15258737Andersen KL, Echwald SM, Larsen LH, Hamid YH, Glumer C, Jorgensen T, Borch-Johnsen K, Andersen T, Sorensen TI, Hansen T, Pedersen O. Variation of the McKusick-Kaufman gene and studies of relationships with common forms of obesity. J Clin Endocrinol Metab. 2005 Jan;90(1):225-30. doi: 10.1210/jc.2004-0465. Epub 2004 Oct 13.
PubMed 15483080Husemoen LL, Thomsen TF, Fenger M, Jorgensen T. Effect of lifestyle factors on plasma total homocysteine concentrations in relation to MTHFR(C677T) genotype. Inter99 (7). Eur J Clin Nutr. 2004 Aug;58(8):1142-50. doi: 10.1038/sj.ejcn.1601942.
PubMed 15054427Kessel L, Hougaard JL, Mortensen C, Jorgensen T, Lund-Andersen H, Larsen M. Visual acuity and refractive errors in a suburban Danish population: Inter99 Eye Study. Acta Ophthalmol Scand. 2004 Feb;82(1):19-24. doi: 10.1111/j.1395-3907.2004.0179.x.
PubMed 14738485Andersen G, Wegner L, Yanagisawa K, Rose CS, Lin J, Glumer C, Drivsholm T, Borch-Johnsen K, Jorgensen T, Hansen T, Spiegelman BM, Pedersen O. Evidence of an association between genetic variation of the coactivator PGC-1beta and obesity. J Med Genet. 2005 May;42(5):402-7. doi: 10.1136/jmg.2004.026278.
PubMed 15863669Andersen G, Wegner L, Jensen DP, Glumer C, Tarnow L, Drivsholm T, Poulsen P, Hansen SK, Nielsen EM, Ek J, Mouritzen P, Vaag A, Parving HH, Borch-Johnsen K, Jorgensen T, Hansen T, Pedersen O. PGC-1alpha Gly482Ser polymorphism associates with hypertension among Danish whites. Hypertension. 2005 Apr;45(4):565-70. doi: 10.1161/01.HYP.0000158946.53289.24. Epub 2005 Feb 28.
PubMed 15738346Hansen SK, Nielsen EM, Ek J, Andersen G, Glumer C, Carstensen B, Mouritzen P, Drivsholm T, Borch-Johnsen K, Jorgensen T, Hansen T, Pedersen O. Analysis of separate and combined effects of common variation in KCNJ11 and PPARG on risk of type 2 diabetes. J Clin Endocrinol Metab. 2005 Jun;90(6):3629-37. doi: 10.1210/jc.2004-1942. Epub 2005 Mar 29.
PubMed 15797964
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99
- ClinicalTrials.gov ID
- NCT00289237
- Acronym / sponsor ID
- RCPH - 99-1
- Conditions
- CHD, AMI, CVD, Type 2 Diabetes, COLD
- Keywords
- Lifestyle intervention, Behavioural changes, CHD, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61,301 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Study start
- Mar 1999
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Feb 2006 (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.
In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results, most probably due to insufficient interventions and methodology.
Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.
After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.
The status for the project is that the four waves of intervention have been performed, the last follow-up was in March 2006.
Data collection finalized with 10 years follow-up via Central National Registries and a questionnaire. No further follow-up is scheduled for the main purposes of the study.
Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin off project are on-going.
More than 25 Ph.d. studies and more than 200 peer-review publication have so far been produced.
Summary of results, links to articles and theses at: www.Inter99.dk
Detailed description
In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results.
Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.
After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity intervention group | Experimental | Behavioral: Lifestyle interventionLifestyle intervention consisted of 15-30 minutes of individual lifestyle counselling + offer of participation in group-based lifestyle counselling (½ year). This offer was given at baseline to all participants in the group. Persons at high risk of IHD: offer additionally given at 1- and 3-year follow-up |
| Low intensity intervention group | Experimental | Behavioral: Lifestyle interventionLifestyle intervention consisted of 15-30 minutes of individual lifestyle counselling. This offer was given at baseline to all participants in the group. Persons at high risk of IHD: offer additionally given at 1- and 3-year follow-up |
| Control group | No intervention | –Questionnaires regarding lifestyle and general health were sent to all participants in this group. The importance of healthy lifestyle was not mentioned, and no intervention was offered. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All citizens in a predefined area
Key exclusion criteria (2 listed)
- Drug abuse
- Language problem
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 |
|---|---|---|
| Lifestyle intervention | Behavioural | High intensity intervention group, Low intensity intervention group |
Primary outcome
Incidence of CHD and other lifestyle related diseases after ten years
Time frame: 2012
Ongoing analyses in National Central Registers (Oct 2012)
1 secondary outcome
Changes in lifestyle and biological markers after one, three and five years
Time frame: 2006
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 3 Oct 2012.
- Background: PubMed 12882858Glumer C, Jorgensen T, Borch-Johnsen K; Inter99 study. Prevalences of diabetes and impaired glucose regulation in a Danish population: the Inter99 study. Diabetes Care. 2003 Aug;26(8):2335-40. doi: 10.2337/diacare.26.8.2335.
- Background: PubMed 12687650Husemoen LL, Thomsen TF, Fenger M, Jorgensen HL, Jorgensen T. Contribution of thermolabile methylenetetrahydrofolate reductase variant to total plasma homocysteine levels in healthy men and women. Inter99 (2). Genet Epidemiol. 2003 May;24(4):322-30. doi: 10.1002/gepi.10239.
- Background: PubMed 14634682Jorgensen ME, Glumer C, Bjerregaard P, Gyntelberg F, Jorgensen T, Borch-Johnsen K; Grennland Population Study. Obesity and central fat pattern among Greenland Inuit and a general population of Denmark (Inter99): relationship to metabolic risk factors. Int J Obes Relat Metab Disord. 2003 Dec;27(12):1507-15. doi: 10.1038/sj.ijo.0802434.
- Background: PubMed 14663300Jorgensen T, Borch-Johnsen K, Thomsen TF, Ibsen H, Glumer C, Pisinger C. A randomized non-pharmacological intervention study for prevention of ischaemic heart disease: baseline results Inter99. Eur J Cardiovasc Prev Rehabil. 2003 Oct;10(5):377-86. doi: 10.1097/01.hjr.0000096541.30533.82.
- Background: PubMed 12835617Nielsen EM, Hansen L, Echwald SM, Drivsholm T, Borch-Johnsen K, Ekstrom CT, Hansen T, Pedersen O. Evidence for an association between the Leu162Val polymorphism of the PPARalpha gene and decreased fasting serum triglyceride levels in glucose tolerant subjects. Pharmacogenetics. 2003 Jul;13(7):417-23. doi: 10.1097/01.fpc.0000054105.48725.5c.
- Background: PubMed 14988293Glumer C, Carstensen B, Sandbaek A, Lauritzen T, Jorgensen T, Borch-Johnsen K; inter99 study. A Danish diabetes risk score for targeted screening: the Inter99 study. Diabetes Care. 2004 Mar;27(3):727-33. doi: 10.2337/diacare.27.3.727.
- Background: PubMed 15270791Glumer C, Jorgensen T, Borch-Johnsen K. Targeted screening for undiagnosed diabetes reduces the number of diagnostic tests. Inter99(8). Diabet Med. 2004 Aug;21(8):874-80. doi: 10.1111/j.1464-5491.2004.01260.x.
- Background: PubMed 15170498Hansen SK, Gjesing AP, Rasmussen SK, Glumer C, Urhammer SA, Andersen G, Rose CS, Drivsholm T, Torekov SK, Jensen DP, Ekstrom CT, Borch-Johnsen K, Jorgensen T, McCarthy MI, Hansen T, Pedersen O. Large-scale studies of the HphI insulin gene variable-number-of-tandem-repeats polymorphism in relation to Type 2 diabetes mellitus and insulin release. Diabetologia. 2004 Jun;47(6):1079-87. doi: 10.1007/s00125-004-1418-3. Epub 2004 May 29.
- Background: PubMed 15258737Johansen A, Nielsen EM, Andersen G, Hamid YH, Jensen DP, Glumer C, Drivsholm T, Borch-Johnsen K, Jorgensen T, Hansen T, Pedersen O. Large-scale studies of the functional K variant of the butyrylcholinesterase gene in relation to Type 2 diabetes and insulin secretion. Diabetologia. 2004 Aug;47(8):1437-41. doi: 10.1007/s00125-004-1459-7. Epub 2004 Jul 17.
- Background: PubMed 15483080Andersen KL, Echwald SM, Larsen LH, Hamid YH, Glumer C, Jorgensen T, Borch-Johnsen K, Andersen T, Sorensen TI, Hansen T, Pedersen O. Variation of the McKusick-Kaufman gene and studies of relationships with common forms of obesity. J Clin Endocrinol Metab. 2005 Jan;90(1):225-30. doi: 10.1210/jc.2004-0465. Epub 2004 Oct 13.
- Background: PubMed 15054427Husemoen LL, Thomsen TF, Fenger M, Jorgensen T. Effect of lifestyle factors on plasma total homocysteine concentrations in relation to MTHFR(C677T) genotype. Inter99 (7). Eur J Clin Nutr. 2004 Aug;58(8):1142-50. doi: 10.1038/sj.ejcn.1601942.
- Background: PubMed 14738485Kessel L, Hougaard JL, Mortensen C, Jorgensen T, Lund-Andersen H, Larsen M. Visual acuity and refractive errors in a suburban Danish population: Inter99 Eye Study. Acta Ophthalmol Scand. 2004 Feb;82(1):19-24. doi: 10.1111/j.1395-3907.2004.0179.x.
- Study description and results. All publications available. Also in English.Link provided by the sponsor.
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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.
Torben Jørgensen, DrMedSci principal investigator
Research Centre for Prevention and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with CHD and AMI, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 1 inclusion and 2 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 3 Oct 2012. 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 Denmark. 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?
Incidence of CHD and other lifestyle related diseases after ten years (time frame: 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00289237, which also lists 54 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 3 Oct 2012.