Cardiovascular DiseasesNCT00005150
Minnesota Heart Health Program
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.
Trial summary
To conduct a large-scale community-based demonstration and education research project designed to evaluate the effectiveness of multiple educational strategies on risk factor reduction and the primary prevention of population-wide cardiovascular diseases in three intervention communities compared with three control… 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, Cerebrovascular Accident
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1980to Jun 1993
- 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 conduct a large-scale community-based demonstration and education research project designed to evaluate the effectiveness of multiple educational strategies on risk factor reduction and the primary prevention of population-wide cardiovascular diseases in three intervention communities compared with three control communities. The program was evaluated by cross-sectional surveys, a longitudinal survey, and morbidity and mortality surveillance.
Read the detailed description
BACKGROUND:
The rationale for prevention derives from the mass nature of adult cardiovascular diseases in affluent societies, the insidious development of the underlying processes, particularly hypertension and atherosclerosis, the high immediate out-of hospital mortality of coronary disease and stroke, and the long-term excessive risk after survival of an initial episode.
The potential for a preventive approach in cardiovascular diseases was based on the large differences in disease rates found between populations and the strong associations between individual risk factor levels and disease rates within high risk cultures. The congruence of these population observations with clinical evidence and with plausible mechanisms of cause, strengthened inference of their causal importance. Further, the safety and feasibility were well established of modifying individuals' cardiovascular risk characteristics and changing personal health behavior through medical and educational strategies. Finally, the dynamic nature of the changes in vital statistics on deaths reported from hypertension, stroke, and coronary heart disease (CHD) in many nations, at the rate of one to two percent a year and greater, both upward and downward, indicated their preventability, though none of these trends was adequately explained when the study began in 1980.
The rationale for a population or community-wide strategy, as in the Minnesota Heart Health Program, contrasted to a high-risk individual, medical approach, was based on all the above considerations, plus the demonstration that entire populations were at excess risk relative to others. Focusing solely on the portion of higher risk people among high risk cultures appeared to be a necessary medical part of a community-wide prevention approach, but it was insufficient and inefficient as a sole or major public health strategy. This was mainly because the bulk of attributable (excess) cases of cardiovascular disease came from the large central part of the population distribution of risk, not the tail. The socially learned behaviors which lead to the precursors of cardiovascular disease were also mass phenomena, requiring a population strategy of prevention and health promotion. Finally, concentration of preventive effort only among the high risk or only on adults tended to ignore the mass emergence of youth into early adulthood bearing the physical characteristics of excess risk and already having well-developed unhealthy behaviors. Therefore, a rational and effective public health strategy would appear to be one directed toward all ages and segments of the community, over a sustained period, with the ultimate objective to prevent elevated risk and risky behaviors in the first place.
DESIGN NARRATIVE:
Three pairs of communities were selected, each pair with one education and one control community. Communities were matched on size and distance from Minneapolis-St. Paul and pairs were similar in median income, education, health care, and media resources. The first pair, Mankato and Winona, were small agricultural communities of approximately 40,000 in population in 1980. The second pair, Fargo, North Dakota and Moorhead, Minnesota paired with Sioux Falls, South Dakota, were medium-sized urban centers of approximately 100,000 in population. Bloomington and Roseville, Minnesota were suburban centers in the Twin Cities metropolitan area with a population of approximately 80,000.
The education program began in Mankato in 1981 after two baseline surveys, in Fargo-Moorhead in 1982 after three baseline surveys, and in Bloomington in 1983 after four baseline surveys. Education activities continued in the three communities for five years concluding in the staged manner in which they began. Targeted risk factors included blood pressure, exercise habits, smoking, and blood cholesterol levels. Health messages were communicated by involvement of community leaders and organizations, media education, population-based risk factor screening and education, adult education classes, youth and parent education disseminated in schools, health professional's educa0tion, and community-wide risk factor education campaigns.
The effectiveness of the program was evaluated by annual population survey samples of cross-sections or cohorts and by morbidity and mortality surveillance. The annual risk factor survey measured community and individual change in risk factors and related behaviors in 25-74 year old persons living in each of the six sites. Annual surveys included between 300-500 persons and were population-based, random, neighborhood cluster samples of each town. Selected households were invited to participate. A home interview was conducted to collect data on health beliefs, attitudes, and behaviors, medical history, health message exposure, and demographic characterization. After the home interview, participants had additional risk factor measurements at a survey center. Data were collected on height, weight, blood pressure, serum total and HDL cholesterol, and serum thiocyanate. In each community, a 50 percent sample of subjects was assessed for dietary habits and the other 50 percent for physical activity.
Morbidity and mortality data on myocardial infarction and stroke were collected and analyzed for the Minnesota Heart Health Program areas and mortality data for all of Minnesota, North Dakota, and South Dakota. Computer classification algorithms were developed jointly with the Pawtucket Heart Health Program and the Stanford Five-City Multifactor Risk Reduction Program to allow pooling of data of the three studies. All hospitalized cases of myocardial infarction and stroke were investigated and cause of death was validated for cardiovascular disease deaths occurring out-of-hospital. Deaths occurring throughout Minnesota, North and South Dakota were catalogued. Hospital disease surveillance was carried out with the cooperation of 34 area hospitals. Mortality was ascertained by death certificate counts and from tapes supplied by the three State Health Departments. Morbidity and mortality data were compared between pooled education versus pooled comparison communities and mortality data were compared between these and the remaining areas of the three states.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Myocardial Infarction, Hypertension, Coronary Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Stroke, Myocardial Infarction, Hypertension, Coronary Disease
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 1980
- Study completionJun 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (133)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005150
- Sponsor's protocol ID
- 1021
- Other IDs
- R01HL025523
- Status last verified
- Feb 2016
- First submitted
- 25 May 2000
- Last updated
- 25 Feb 2016
- Results posted
- No
Publications
Murray DM, Perry CL, Davis MA: Cardiovascular Risk Reduction in Children. Education and Treatment of Children, 10(1):48-57, 1987
Perry CL, Crockett SJ, Pirie P: Influencing Parental Health Behavior: Implications of Community Assessments. Health Educ, 18:5, 1987
Perry CL, Klepp KI, Halper A, Dudovitz B, Golden D, Griffin G, Smyth M: Promoting Healthy Eating and Physical Activity Patterns Among Adolescents: A Pilot Study of 'Slice of Life' Health Educ Research, 2(2):93-103, 1987
Perry CL, Silvis GL. Smoking prevention: behavioral prescriptions for the pediatrician. Pediatrics. 1987 May;79(5):790-9.
PubMed 3575039Sorensen G, Pechacek TF. Attitudes toward smoking cessation among men and women. J Behav Med. 1987 Apr;10(2):129-37. doi: 10.1007/BF00846421.
PubMed 3612774Perry CL, Murray DM, Klepp KI; Centers for Disease Control (CDC). Predictors of adolescent smoking and implications for prevention. MMWR Suppl. 1987 Sep 4;36(4):41S-45S. No abstract available.
PubMed 3116396Jeffery RW: Behavioral Treatment of Obesity. Ann Behav Med, 9(1):20-24, 1987
Jeffery RW, Forster JL: Obesity as a Public Health Problem, Chapter 11. In: Johnson WG (Ed), Advances in Eating Disorders, Vol. I: Treating and Preventing Obesity. Greenwich, CT: Jai Press, Inc., pp 253-271, 1987
Silvis GL, Perry CL. Understanding and deterring tobacco use among adolescents. Pediatr Clin North Am. 1987 Apr;34(2):363-79. doi: 10.1016/s0031-3955(16)36221-6.
PubMed 3550658Jeffery RW. Dietary risk factors and their modification in cardiovascular disease. J Consult Clin Psychol. 1988 Jun;56(3):350-7. doi: 10.1037//0022-006x.56.3.350. No abstract available.
PubMed 3294260Perry CL. Results of prevention programs with adolescents. Drug Alcohol Depend. 1987 Sep;20(1):13-9. doi: 10.1016/0376-8716(87)90071-8.
PubMed 3678039Bracht NF. Use of community analysis methods in community-wide intervention programs. Scand J Prim Health Care Suppl. 1988;1:23-30.
PubMed 3227199Rastam L, Luepker RV, Mittelmark MB, Murray DM, Slater JS, Blackburn H. Population screening and referral for hypercholesterolemia. Am J Prev Med. 1988 Sep-Oct;4(5):249-54.
PubMed 3224001Rastam L, Admire JB, Frantz ID Jr, Hellerstedt W, Hunninghake DM, Kuba K, Luepker RV. Measurement of blood cholesterol with the Reflotron analyzer evaluated. Clin Chem. 1988 Feb;34(2):426. No abstract available.
PubMed 3342525Mittelmark MB, Leupker RV, Grimm R Jr, Kottke TE, Blackburn H. The role of physicians in a community-wide program for prevention of cardiovascular disease: the Minnesota Heart Health Program. Public Health Rep. 1988 Jul-Aug;103(4):360-5.
PubMed 3136495
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minnesota Heart Health Program
- ClinicalTrials.gov ID
- NCT00005150
- Acronym / sponsor ID
- 1021
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Myocardial Infarction, Hypertension, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1980
- Study completion
- Jun 1993
- 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 conduct a large-scale community-based demonstration and education research project designed to evaluate the effectiveness of multiple educational strategies on risk factor reduction and the primary prevention of population-wide cardiovascular diseases in three intervention communities compared with three control communities. The program was evaluated by cross-sectional surveys, a longitudinal survey, and morbidity and mortality surveillance.
Detailed description
BACKGROUND:
The rationale for prevention derives from the mass nature of adult cardiovascular diseases in affluent societies, the insidious development of the underlying processes, particularly hypertension and atherosclerosis, the high immediate out-of hospital mortality of coronary disease and stroke, and the long-term excessive risk after survival of an initial episode.
The potential for a preventive approach in cardiovascular diseases was based on the large differences in disease rates found between populations and the strong associations between individual risk factor levels and disease rates within high risk cultures. The congruence of these population observations with clinical evidence and with plausible mechanisms of cause, strengthened inference of their causal importance. Further, the safety and feasibility were well established of modifying individuals' cardiovascular risk characteristics and changing personal health behavior through medical and educational strategies. Finally, the dynamic nature of the changes in vital statistics on deaths reported from hypertension, stroke, and coronary heart disease (CHD) in many nations, at the rate of one to two percent a year and greater, both upward and downward, indicated their preventability, though none of these trends was adequately explained when the study began in 1980.
The rationale for a population or community-wide strategy, as in the Minnesota Heart Health Program, contrasted to a high-risk individual, medical approach, was based on all the above considerations, plus the demonstration that entire populations were at excess risk relative to others. Focusing solely on the portion of higher risk people among high risk cultures appeared to be a necessary medical part of a community-wide prevention approach, but it was insufficient and inefficient as a sole or major public health strategy. This was mainly because the bulk of attributable (excess) cases of cardiovascular disease came from the large central part of the population distribution of risk, not the tail. The socially learned behaviors which lead to the precursors of cardiovascular disease were also mass phenomena, requiring a population strategy of prevention and health promotion. Finally, concentration of preventive effort only among the high risk or only on adults tended to ignore the mass emergence of youth into early adulthood bearing the physical characteristics of excess risk and already having well-developed unhealthy behaviors. Therefore, a rational and effective public health strategy would appear to be one directed toward all ages and segments of the community, over a sustained period, with the ultimate objective to prevent elevated risk and risky behaviors in the first place.
DESIGN NARRATIVE:
Three pairs of communities were selected, each pair with one education and one control community. Communities were matched on size and distance from Minneapolis-St. Paul and pairs were similar in median income, education, health care, and media resources. The first pair, Mankato and Winona, were small agricultural communities of approximately 40,000 in population in 1980. The second pair, Fargo, North Dakota and Moorhead, Minnesota paired with Sioux Falls, South Dakota, were medium-sized urban centers of approximately 100,000 in population. Bloomington and Roseville, Minnesota were suburban centers in the Twin Cities metropolitan area with a population of approximately 80,000.
The education program began in Mankato in 1981 after two baseline surveys, in Fargo-Moorhead in 1982 after three baseline surveys, and in Bloomington in 1983 after four baseline surveys. Education activities continued in the three communities for five years concluding in the staged manner in which they began. Targeted risk factors included blood pressure, exercise habits, smoking, and blood cholesterol levels. Health messages were communicated by involvement of community leaders and organizations, media education, population-based risk factor screening and education, adult education classes, youth and parent education disseminated in schools, health professional's educa0tion, and community-wide risk factor education campaigns.
The effectiveness of the program was evaluated by annual population survey samples of cross-sections or cohorts and by morbidity and mortality surveillance. The annual risk factor survey measured community and individual change in risk factors and related behaviors in 25-74 year old persons living in each of the six sites. Annual surveys included between 300-500 persons and were population-based, random, neighborhood cluster samples of each town. Selected households were invited to participate. A home interview was conducted to collect data on health beliefs, attitudes, and behaviors, medical history, health message exposure, and demographic characterization. After the home interview, participants had additional risk factor measurements at a survey center. Data were collected on height, weight, blood pressure, serum total and HDL cholesterol, and serum thiocyanate. In each community, a 50 percent sample of subjects was assessed for dietary habits and the other 50 percent for physical activity.
Morbidity and mortality data on myocardial infarction and stroke were collected and analyzed for the Minnesota Heart Health Program areas and mortality data for all of Minnesota, North Dakota, and South Dakota. Computer classification algorithms were developed jointly with the Pawtucket Heart Health Program and the Stanford Five-City Multifactor Risk Reduction Program to allow pooling of data of the three studies. All hospitalized cases of myocardial infarction and stroke were investigated and cause of death was validated for cardiovascular disease deaths occurring out-of-hospital. Deaths occurring throughout Minnesota, North and South Dakota were catalogued. Hospital disease surveillance was carried out with the cooperation of 34 area hospitals. Mortality was ascertained by death certificate counts and from tapes supplied by the three State Health Departments. Morbidity and mortality data were compared between pooled education versus pooled comparison communities and mortality data were compared between these and the remaining areas of the three states.
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 25 Feb 2016.
- BackgroundMurray DM, Perry CL, Davis MA: Cardiovascular Risk Reduction in Children. Education and Treatment of Children, 10(1):48-57, 1987
- BackgroundPerry CL, Crockett SJ, Pirie P: Influencing Parental Health Behavior: Implications of Community Assessments. Health Educ, 18:5, 1987
- BackgroundPerry CL, Klepp KI, Halper A, Dudovitz B, Golden D, Griffin G, Smyth M: Promoting Healthy Eating and Physical Activity Patterns Among Adolescents: A Pilot Study of 'Slice of Life' Health Educ Research, 2(2):93-103, 1987
- Background: PubMed 3575039Perry CL, Silvis GL. Smoking prevention: behavioral prescriptions for the pediatrician. Pediatrics. 1987 May;79(5):790-9.
- Background: PubMed 3612774Sorensen G, Pechacek TF. Attitudes toward smoking cessation among men and women. J Behav Med. 1987 Apr;10(2):129-37. doi: 10.1007/BF00846421.
- Background: PubMed 3116396Perry CL, Murray DM, Klepp KI; Centers for Disease Control (CDC). Predictors of adolescent smoking and implications for prevention. MMWR Suppl. 1987 Sep 4;36(4):41S-45S. No abstract available.
- BackgroundJeffery RW: Behavioral Treatment of Obesity. Ann Behav Med, 9(1):20-24, 1987
- BackgroundJeffery RW, Forster JL: Obesity as a Public Health Problem, Chapter 11. In: Johnson WG (Ed), Advances in Eating Disorders, Vol. I: Treating and Preventing Obesity. Greenwich, CT: Jai Press, Inc., pp 253-271, 1987
- Background: PubMed 3550658Silvis GL, Perry CL. Understanding and deterring tobacco use among adolescents. Pediatr Clin North Am. 1987 Apr;34(2):363-79. doi: 10.1016/s0031-3955(16)36221-6.
- Background: PubMed 3294260Jeffery RW. Dietary risk factors and their modification in cardiovascular disease. J Consult Clin Psychol. 1988 Jun;56(3):350-7. doi: 10.1037//0022-006x.56.3.350. No abstract available.
- Background: PubMed 3678039Perry CL. Results of prevention programs with adolescents. Drug Alcohol Depend. 1987 Sep;20(1):13-9. doi: 10.1016/0376-8716(87)90071-8.
- Background: PubMed 3227199Bracht NF. Use of community analysis methods in community-wide intervention programs. Scand J Prim Health Care Suppl. 1988;1:23-30.
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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 University of Minnesota.
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 25 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 NCT00005150, which also lists 133 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 25 Feb 2016.