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Minnesota Heart Health Program

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 24, 2016
    Sponsor
    University of Minnesota
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005150
    Brief Title
    Minnesota Heart Health Program
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1980 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 1993 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Minnesota
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Myocardial Infarction, Hypertension, Coronary Disease

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

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    Perry CL, Murray DM. Enhancing the transition years: the challenge of adolescent health promotion. J Sch Health. 1982 May;52(5):307-11. doi: 10.1111/j.1746-1561.1982.tb04628.x. No abstract available.
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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. doi: 10.2105/ajph.73.6.691.
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    Kline FG: The Minnesota Heart Health Project: Field Intervention in American Communities. In: Att Forandra Levnadssatt: Rapport fran ett Symposium om Metoder att Forbattra Folkhalsan (In: To Change Lifestyles: Report From a Symposium on Methods to Improve Public Health). Arvidsson O (Ed), Riksbankens Jubileumsfond, Stockholm, 1983
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    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. doi: 10.1016/0091-7435(83)90211-6.
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    Leon A, Blackburn H: Physical Inactivity. In: Prevention of Coronary Heart Disease, Kaplan NM, Stamler J (Ed), W.B. Saunders Co., New York, pp 86-97, 1983
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    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. doi: 10.1007/BF00845276.
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    Pavlik JV: The Effects of Two Health Information Campaigns on the Complexity of Cognitive Structure: An Information Processing Approach. Doctoral Dissertation, School of Journalism, University of Minnesota, Minneapolis, 1983
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    Pechacek TF, Grimm RH: Cigarette Smoking and the Prevention of Coronary Disease: Principles for Effective Smoking Cessation Programs for Health Professionals. In: Physician's Guide to the Prevention of Coronary Heart Disease. Podell RN, Stewart MM (Eds), Addison-Wesley, Palo Alto, pp 34-77, 1983
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    Prineas RJ, Jacobs D. Quality of Korotkoff sounds: bell vs diaphragm, cubital fossa vs brachial artery. Prev Med. 1983 Sep;12(5):715-9. doi: 10.1016/0091-7435(83)90229-3.
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    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. doi: 10.1016/0021-9150(83)90134-x.
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    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. doi: 10.1007/BF01318934.
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    Blackburn H, Luepker R, Kline FG, Bracht N, Carlaw R, Jacobs DR, Mittelmark M, Stauffer L, Taylor HL: The Minnesota Heart Health Program: A Research and Demonstration Project in Cardiovascular Disease Prevention. In: Behavioral Health: A Handbook for Health Enhancement and Disease Prevention, Matarazzo J et al (Eds), John Wiley & Sons, New York, 1984
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    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. doi: 10.2105/ajph.74.5.492.
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    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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    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. doi: 10.2105/ajph.74.6.564.
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    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. doi: 10.1093/ije/13.4.436.
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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. doi: 10.1016/0091-7435(84)90053-7.
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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. No abstract available.
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    Mullis RM, Bowen PE. Process guides for nutrition care in community health. J Am Diet Assoc. 1985 Jan;85(1):73-6.
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    Perry CL. A conceptual approach to school-based health promotion. J Sch Health. 1984;54(6):33-8.
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    Sopko G, Jacobs DR Jr, Taylor HL. Dietary measures of physical activity. Am J Epidemiol. 1984 Dec;120(6):900-11. doi: 10.1093/oxfordjournals.aje.a113961.
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    Carlaw RW, Mittlemark MB, Bracht N, Luepker R. Organization for a community cardiovascular health program: experiences from the Minnesota Heart Health Program. Health Educ Q. 1984 Fall;11(3):243-52. doi: 10.1177/109019818401100303.
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    Blackburn H, Pechacek T: Smoking Cessation and the Minnesota Heart Health Program. In: Proceedings of the 5th World Conference on Smoking and Health, Nosbakken D (Ed), 1984
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    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. doi: 10.1037//0022-006x.53.6.905. No abstract available.
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    Perry CL, Mullis RM, Maile MC. Modifying the eating behavior of young children. J Sch Health. 1985 Dec;55(10):399-402. doi: 10.1111/j.1746-1561.1985.tb01163.x.
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    Perry CL, Griffin G, Murray DM. Assessing needs for youth health promotion. Prev Med. 1985 May;14(3):379-93. doi: 10.1016/0091-7435(85)90064-7.
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    Mittelmark MB, Luepker RV, Jacobs DR, Bracht NF, Carlaw RW, Crow RS, Finnegan J, Grimm RH, Jeffery RW, Kline FG, et al. Community-wide prevention of cardiovascular disease: education strategies of the Minnesota Heart Health Program. Prev Med. 1986 Jan;15(1):1-17. doi: 10.1016/0091-7435(86)90031-9.
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    Mullis RM, Lansing D: Using Focus Groups to Plan Worksite Nutrition Programs. J Nutr Educ, Special Supplement, 18(2):32-33, 1986
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    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. doi: 10.1111/j.1746-1561.1986.tb01176.x.
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    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.
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    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. doi: 10.2105/ajph.76.5.544.
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    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. doi: 10.1111/j.0954-6820.1986.tb08937.x.
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    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. doi: 10.1016/0021-9681(86)90195-5.
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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. doi: 10.1016/0091-7435(86)90071-x.
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    Murray DM. Dissemination of community health promotion programs: the Fargo-Moorhead Heart Health Program. J Sch Health. 1986 Nov;56(9):375-81. doi: 10.1111/j.1746-1561.1986.tb05776.x.
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    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. doi: 10.1016/0021-9681(86)90080-9.
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    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. doi: 10.1016/0091-7435(86)90064-2.
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    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. doi: 10.1093/ije/15.2.176.
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    Luepker R, Murray D, Prineas R. [Primary prevention of hypertension in childhood (the population approach)]. Kardiologiia. 1986 Jan;26(1):69-77. Russian.
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    Mullis RM, Perry CL, Pirie PL: A Model for Levels of Community Health Promotion. In: Coates AY and Frankle RT (Eds), Nutrition in the Community: The Art of Delivering Services, 2nd Edition. St. Louis: Times Mirror/Mosby College Publishing, 1986
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    Murray D, Luepker R, Grimm R, Blackburn H. [Prevention and treatment of hypertension at the population level: the Minnesota Heart Health Program]. Kardiologiia. 1986 Jan;26(1):78-84. Russian.
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    Blackburn H: Atherosclerosis and Coronary Heart Disease. Strategy for Change: A Population Approach to Prevention. In: Fidge NH, Nestel PJ (Eds), Atherosclerosis VII. New York: Elsevier Science Publishers B.V., pp 15-17, 1986
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    Murray DM, Leupker RV, Grimm R, Blackburn H: Prevention and Treatment of Hypertension at a Community Level: The Minnesota Heart Health Program. In: Horan MJ, Shkvatsabaya IK (Eds), Hypertension: Psychophysiological, Biobehavioral, and Epidemiological Aspects. NIH Publication No. 86-2704, Washington, DC: U.S. Government Printing Office, pp 183-191, 1986
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    Luepker RV: Coronary Heart Disease Risk Factor Reduction in the Elderly. Quality of Life and Cardiovascular Care, 2(4):159-175, 1986
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    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
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    Mullis RM, Hunt MK, Foster M, Hachfeld L, Lansing D, Synder P, Pirie P: Environmental Support of Healthful Food Behavior: The Shop Smart For Your Heart Grocery Program. J Nutr Educ, 19(5):225-228, 1987
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