Minnesota Heart Health Program

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005150
• Other study ID #: 1021
• Secondary ID: R01HL025523
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: February 24, 2016
• Start date: July 1980
• Est. completion date: June 1993

Study information

• Verified date: February 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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 communities. The program was evaluated by cross-sectional surveys, a longitudinal survey, and morbidity and mortality surveillance.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 1993
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Accident
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypertension
• Myocardial Infarction
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (131)

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Bracht NF. Use of community analysis methods in community-wide intervention programs. Scand J Prim Health Care Suppl. 1988;1:23-30. — View Citation

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Coates TJ, Petersen A, Perry C (Eds): Promoting Adolescent Health: A Dialog on Research and Practice. Academic Press, New York, 1982

Crockett SJ, Mullis R, Perry CL, Luepker RV. Parent education in youth-directed nutrition interventions. Prev Med. 1989 Jul;18(4):475-91. Review. — View Citation

Crockett SJ, Mullis RM, Perry CL. Parent nutrition education: a conceptual model. J Sch Health. 1988 Feb;58(2):53-7. — View Citation

Crow R, Blackburn H, Jacobs D, Hannan P, Pirie P, Mittelmark M, Murray D, Luepker R. Population strategies to enhance physical activity: the Minnesota Heart Health Program. Acta Med Scand Suppl. 1986;711:93-112. — View Citation

DiAngelis N, Luepker RV. The effect of the dental setting on blood pressure measurement. Am J Public Health. 1983 Oct;73(10):1210-2. — View Citation

Ettema JS, Brown JW, Luepker RV. Knowledge gap effects in a health information campaign. Public Opin Q. 1983 Winter;47(4):516-27. — View Citation

Finnegan JR Jr, Murray DM, Kurth C, McCarthy P. Measuring and tracking education program implementation: the Minnesota Heart Health Program experience. Health Educ Q. 1989 Spring;16(1):77-90. — View Citation

Finnegan JR, Loken B, Howard-Pitney B: Using Direct Mail to Bridge 'Knowledge Gaps' in Communication About Health. J Direct Marketing, 1(Summer):3, 1987

Folsom AR, Jacobs DR Jr, Caspersen CJ, Gomez-Marin O, Knudsen J. Test-retest reliability of the Minnesota Leisure Time Physical Activity Questionnaire. J Chronic Dis. 1986;39(7):505-11. — View Citation

Folsom AR, Kuba K, Leupker RV, Jacobs DR, Frantz ID Jr. Lipid concentrations in serum and EDTA-treated plasma from fasting and nonfasting normal persons, with particular regard to high-density lipoprotein cholesterol. Clin Chem. 1983 Mar;29(3):505-8. — View Citation

Folsom AR, Pechacek TF, de Gaudemaris R, Luepker RV, Jacobs DR Jr, Gillum RF. Consumption of 'low-yield' cigarettes: its frequency and relationship to serum thiocyanate. Am J Public Health. 1984 Jun;74(6):564-8. — View Citation

Folsom AR, Prineas RJ, Jacobs DR, Luepker RV, Gillum RF. Measured differences between fourth and fifth phase diastolic blood pressures in 4885 adults: implications for blood pressure surveys. Int J Epidemiol. 1984 Dec;13(4):436-41. — View Citation

Forster JL, Bloom E, Sorensen G, Jeffery RW, Prineas RJ. Reproductive history and body mass index in black and white women. Prev Med. 1986 Nov;15(6):685-91. — View Citation

Forster JL, Jeffery RW, Schmid TL, Kramer FM. Preventing weight gain in adults: a pound of prevention. Health Psychol. 1988;7(6):515-25. — View Citation

Forster JL, Jeffery RW, Snell MK. One-year follow-up study to a worksite weight control program. Prev Med. 1988 Jan;17(1):129-33. — View Citation

Gatewood L: Evaluation of Prognostic Indices After Acute MI. Proceedings of Scientific Meeting on Ischemic Heart Disease, Specialized Centers of Research, NHLBI, Bethesda, MD, May 1982

Gillum RF, Prineas RJ, Jeffery RW, Jacobs DR, Elmer PJ, Gomez O, Blackburn H. Nonpharmacologic therapy of hypertension: the independent effects of weight reduction and sodium restriction in overweight borderline hypertensive patients. Am Heart J. 1983 Jan;105(1):128-33. — View Citation

Glanz K, Mullis RM. Environmental interventions to promote healthy eating: a review of models, programs, and evidence. Health Educ Q. 1988 Winter;15(4):395-415. Review. — View Citation

Glasgow RE, Klesges RC, Mizes JS, Pechacek TF. Quitting smoking: strategies used and variables associated with success in a stop-smoking contest. J Consult Clin Psychol. 1985 Dec;53(6):905-12. — View Citation

Grimm RH Jr, Luepker RV, Taylor H, Blackburn H. Long-term effects of a blood pressure survey on patient treatment in a community. Circulation. 1982 May;65(5):946-50. — View Citation

Jacobs DR Jr, Anderson JT, Hannan P, Keys A, Blackburn H. Variability in individual serum cholesterol response to change in diet. Arteriosclerosis. 1983 Jul-Aug;3(4):349-56. — View Citation

Jacobs DR Jr, Luepker RV, Mittelmark MB, Folsom AR, Pirie PL, Mascioli SR, Hannan PJ, Pechacek TF, Bracht NF, Carlaw RW, et al. Community-wide prevention strategies: evaluation design of the Minnesota Heart Health Program. J Chronic Dis. 1986;39(10):775-88. — View Citation

Jeffery RW, Forster JL, Folsom AR, Luepker RV, Jacobs DR Jr, Blackburn H. The relationship between social status and body mass index in the Minnesota Heart Health Program. Int J Obes. 1989;13(1):59-67. — View Citation

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Jeffery RW, Gillum R, Gerber WM, Jacobs D, Elmer PJ, Prineas RJ. Weight and sodium reduction for the prevention of hypertension: a comparison of group treatment and individual counseling. Am J Public Health. 1983 Jun;73(6):691-3. — View Citation

Jeffery RW, Gray CW, French SA, Hellerstedt WL, Murray D, Luepker RV, Blackburn H. Evaluation of weight reduction in a community intervention for cardiovascular disease risk: changes in body mass index in the Minnesota Heart Health Program. Int J Obes Relat Metab Disord. 1995 Jan;19(1):30-9. — View Citation

Jeffery RW, Pheley AM, Forster JL, Kramer FM, Snell MK. Payroll contracting for smoking cessation: a worksite pilot study. Am J Prev Med. 1988 Mar-Apr;4(2):83-6. — View Citation

Jeffery RW, Pirie PL, Elmer PJ, Bjornson-Benson WM, Mullenbach VA, Kurth CL, Johnson SL. Low-sodium, high-potassium diet: feasibility and acceptability in a normotensive population. Am J Public Health. 1984 May;74(5):492-4. — View Citation

Jeffery RW, Pirie PL, Rosenthal BS, Gerber WM, Murray DM. Nutrition education in supermarkets: an unsuccessful attempt to influence knowledge and product sales. J Behav Med. 1982 Jun;5(2):189-200. — View Citation

Jeffery RW. Dietary risk factors and their modification in cardiovascular disease. J Consult Clin Psychol. 1988 Jun;56(3):350-7. Review. — View Citation

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Kottke TE, Foels JK, Hill C, Choi T, Fenderson DA. Nutrition counseling in private practice: attitudes and activities of family physicians. Prev Med. 1984 Mar;13(2):219-25. — View Citation

Kottke TE, Foels JK, Hill C, Choi T, Fenderson DA. Perceived palatability of the prudent diet: results of a dietary demonstration for physicians. Prev Med. 1983 Jul;12(4):588-94. — View Citation

Lando HA, Loken B, Howard-Pitney B, Pechacek T. Community impact of a localized smoking cessation contest. Am J Public Health. 1990 May;80(5):601-3. — View Citation

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Loken B. Heavy smokers', light smokers', and nonsmokers' beliefs about cigarette smoking. J Appl Psychol. 1982 Oct;67(5):616-22. — View Citation

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Luepker RV, Jacobs DR, Brown JW, Sobel JL, Prineas R. Hypertension control in two rural communities. Minn Med. 1984 Jun;67(6):341-4. — View Citation

Luepker RV, Johnson CA, Murray DM, Pechacek TF. Prevention of cigarette smoking: three-year follow-up of an education program for youth. J Behav Med. 1983 Mar;6(1):53-62. — View Citation

Luepker RV, Murray DM, Jacobs DR Jr, Mittelmark MB, Bracht N, Carlaw R, Crow R, Elmer P, Finnegan J, Folsom AR, et al. Community education for cardiovascular disease prevention: risk factor changes in the Minnesota Heart Health Program. Am J Public Health. 1994 Sep;84(9):1383-93. — View Citation

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Luepker RV, Pechacek TF, Murray DM, Johnson CA, Hund F, Jacobs DR. Saliva thiocyanate: a chemical indicator of cigarette smoking in adolescents. Am J Public Health. 1981 Dec;71(12):1320-4. — View Citation

Luepker RV, Perry CL, Murray DM, Mullis R. Hypertension prevention through nutrition education in youth: a school-based program involving parents. Health Psychol. 1988;7 Suppl:233-45. — View Citation

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Murray DM, Luepker RV, Pirie PL, Grimm RH Jr, Bloom E, Davis MA, Blackburn H. Systematic risk factor screening and education: a community-wide approach to prevention of coronary heart disease. Prev Med. 1986 Nov;15(6):661-72. — View Citation

Murray DM, Perry CL, Davis MA: Cardiovascular Risk Reduction in Children. Education and Treatment of Children, 10(1):48-57, 1987

Murray DM. Dissemination of community health promotion programs: the Fargo-Moorhead Heart Health Program. J Sch Health. 1986 Nov;56(9):375-81. — View Citation

Pechacek TF, Fox BH, Murray DM, Luepker RV: Review of Techniques for Measurement of Smoking. In: Behavioral Health: A Handbook of Health Enhancement and Disease Prevention. Matarazzo J, et al (Eds) John Wiley & Sons, New York, 1984

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Perry CL, Crockett SJ, Pirie P: Influencing Parental Health Behavior: Implications of Community Assessments. Health Educ, 18:5, 1987

Perry CL, Griffin G, Murray DM. Assessing needs for youth health promotion. Prev Med. 1985 May;14(3):379-93. — View Citation

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, Klepp KI, Halper A, Hawkins KG, Murray DM. A process evaluation study of peer leaders in health education. J Sch Health. 1986 Feb;56(2):62-7. — View Citation

Perry CL, Klepp KI, Shultz JM. Primary prevention of cardiovascular disease: communitywide strategies for youth. J Consult Clin Psychol. 1988 Jun;56(3):358-64. Review. — View Citation

Perry CL, Luepker RV, Murray DM, Hearn MD, Halper A, Dudovitz B, Maile MC, Smyth M. Parent involvement with children's health promotion: a one-year follow-up of the Minnesota home team. Health Educ Q. 1989 Summer;16(2):171-80. — View Citation

Perry CL, Luepker RV, Murray DM, Kurth C, Mullis R, Crockett S, Jacobs DR Jr. Parent involvement with children's health promotion: the Minnesota Home Team. Am J Public Health. 1988 Sep;78(9):1156-60. — View Citation

Perry CL, Mullis RM, Maile MC. Modifying the eating behavior of young children. J Sch Health. 1985 Dec;55(10):399-402. — View Citation

Perry 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. — View Citation

Perry CL, Murray DM. Enhancing the transition years: the challenge of adolescent health promotion. J Sch Health. 1982 May;52(5):307-11. — View Citation

Perry CL, Silvis GL. Smoking prevention: behavioral prescriptions for the pediatrician. Pediatrics. 1987 May;79(5):790-9. — View Citation

Perry CL. A conceptual approach to school-based health promotion. J Sch Health. 1984;54(6):33-8. — View Citation

Perry CL. Community-wide health promotion and drug abuse prevention. J Sch Health. 1986 Nov;56(9):359-63. — View Citation

Perry CL. Results of prevention programs with adolescents. Drug Alcohol Depend. 1987 Sep;20(1):13-9. — View Citation

Pirie P, Jacobs D, Jeffery R, Hannan P. Distortion in self-reported height and weight data. J Am Diet Assoc. 1981 Jun;78(6):601-6. — View Citation

Pirie PL, Elias WS, Wackman DB, Jacobs DR Jr, Murray DM, Mittelmark MB, Luepker RV, Blackburn H. Characteristics of participants and nonparticipants in a community cardiovascular disease risk factor screening: the Minnesota Heart Health Program. Am J Prev Med. 1986 Jan-Feb;2(1):20-5. — View Citation

Pirie PL, Luepker RV, Jacobs DR Jr, Brown JW, Hall N. Development and validation of a self-scoring test for coronary heart disease risk. J Community Health. 1983 Fall;9(1):65-79. — View Citation

Prineas RJ, Gillum RF, Blackburn H: Possibilities for Primary Prevention of Hypertension. In: Childhood Prevention of Atherosclerosis and Hypertension, Lauer RM, Shekelle RB (Eds), Raven Press, New York, pp 357-366, 1980

Prineas RJ, Jacobs D. Quality of Korotkoff sounds: bell vs diaphragm, cubital fossa vs brachial artery. Prev Med. 1983 Sep;12(5):715-9. — View Citation

Råstam 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. — View Citation

Råstam L, Hannan PJ, Luepker RV, Mittelmark MB, Murray DM, Slater JS. Seasonal variation in plasma cholesterol distributions: implications for screening and referral. Am J Prev Med. 1992 Nov-Dec;8(6):360-6. — View Citation

Råstam 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. — View Citation

Råstam L, Luepker RV, Pirie PL. Effect of screening and referral on follow-up and treatment of high blood cholesterol levels. Am J Prev Med. 1988 Sep-Oct;4(5):244-8. — View Citation

Salonen JT, Kottke TE, Jacobs DR Jr, Hannan PJ. Analysis of community-based cardiovascular disease prevention studies--evaluation issues in the North Karelia Project and the Minnesota Heart Health Program. Int J Epidemiol. 1986 Jun;15(2):176-82. — View Citation

Silvis GL, Perry CL. Understanding and deterring tobacco use among adolescents. Pediatr Clin North Am. 1987 Apr;34(2):363-79. Review. — View Citation

Sopko G, Jacobs DR Jr, Jeffery R, Mittelmark M, Lenz K, Hedding E, Lipchik R, Gerber W. Effects on blood lipids and body weight in high risk men of a practical exercise program. Atherosclerosis. 1983 Dec;49(3):219-29. — View Citation

Sopko G, Jacobs DR Jr, Taylor HL. Dietary measures of physical activity. Am J Epidemiol. 1984 Dec;120(6):900-11. — View Citation

Sorensen G, Pechacek T, Pallonen U. Occupational and worksite norms and attitudes about smoking cessation. Am J Public Health. 1986 May;76(5):544-9. — View Citation

Sorensen G, Pechacek T. Occupational and sex differences in smoking and smoking cessation. J Occup Med. 1986 May;28(5):360-4. — View Citation

Sorensen G, Pechacek TF. Attitudes toward smoking cessation among men and women. J Behav Med. 1987 Apr;10(2):129-37. — View Citation

Sorensen G, Pechacek TF. Implementing nonsmoking policies in the private sector and assessing their effects. N Y State J Med. 1989 Jan;89(1):11-5. — View Citation

Strickland D, Sprafka JM, Luepker RV, Grimm RH Jr. Association of antihypertensive agents and blood lipids in a population-based survey. Epidemiology. 1994 Jan;5(1):96-101. — View Citation

Troein M, Arneson T, Råstam L, Pirie PL, Selander S, Luepker RV. Reported treatment of hypercholesterolemia by family physicians in Sweden and Minnesota. Am J Prev Med. 1995 Sep-Oct;11(5):324-8. — View Citation

Troein M, Arneson T, Råstam L, Pirie PL, Selander S, Luepker RV. Reported treatment of hypertension by family physicians in Sweden and Minnesota: a physician survey of practice habits. J Intern Med. 1995 Sep;238(3):215-21. — View Citation

Venters M, Jacobs DR Jr, Pirie P, Luepker RV, Folsom AR, Gillum RF. Marital status and cardiovascular risk: the Minnesota Heart Survey and the Minnesota Heart Health Program. Prev Med. 1986 Nov;15(6):591-605. — View Citation

Weisbrod RR, Bracht NF, Pirie PL, Veblen-Mortenson S. Current status of health promotion activities in four midwest cities. Public Health Rep. 1991 May-Jun;106(3):310-7. — View Citation

Weisbrod RR, Pirie PL, Bracht NF, Elstun P. Worksite health promotion in four Midwest cities. J Community Health. 1991 Jun;16(3):169-77. — View Citation

Weisbrod RR, Pirie PL, Bracht NF. Impact of a community health promotion program on existing organizations: the Minnesota Heart Health Program. Soc Sci Med. 1992 Mar;34(6):639-48. — View Citation

* Note: There are 131 references in all — Click here to view all references