Clinical trial NCT00005150: Minnesota Heart Health Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Cerebrovascular Accident
Myocardial Infarction
Hypertension
Coronary Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Mullis RM, Lansing D: Using Focus Groups to Plan Worksite Nutrition Programs. J Nutr Educ, Special Supplement, 18(2):32-33, 1986
citation: 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.
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.
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. doi: 10.2105/ajph.76.5.544.
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. doi: 10.1111/j.0954-6820.1986.tb08937.x.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1016/0021-9681(86)90080-9.
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. doi: 10.1016/0091-7435(86)90064-2.
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. doi: 10.1093/ije/15.2.176.
citation: Luepker R, Murray D, Prineas R. [Primary prevention of hypertension in childhood (the population approach)]. Kardiologiia. 1986 Jan;26(1):69-77. Russian.
citation: 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
citation: 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.
citation: 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
citation: 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
citation: Luepker RV, Murray DM, Prineas RJ: Primary Prevention of Hypertension in Youth: A Population Approach. 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 211-226, 1986
citation: Luepker RV: Coronary Heart Disease Risk Factor Reduction in the Elderly. Quality of Life and Cardiovascular Care, 2(4):159-175, 1986
citation: Luepker RV: Prevention of Cigarette Smoking. In: Feldman DA, Stiffman AR (Eds), Advances in Adolescent Mental Health. Greenwich, CT: JAI Press, Inc, 1986
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. doi: 10.1016/0091-7435(86)90073-3.
citation: Perry CL. Community-wide health promotion and drug abuse prevention. J Sch Health. 1986 Nov;56(9):359-63. doi: 10.1111/j.1746-1561.1986.tb05772.x.
citation: Sorensen G, Pechacek T. Occupational and sex differences in smoking and smoking cessation. J Occup Med. 1986 May;28(5):360-4.
citation: Blake SM, Jeffery RW, Finnegan JR, Crow RS, Pirie PL, Ringhofer KR, Fruetel JR, Caspersen CJ, Mittelmark MB: Process Evaluation of a Community-Based Physical Activity Campaign: The Minnesota Heart Health Program Experience. Health Educ Research, 2(2):115-121, 1987
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
citation: Loken B, Pirie PL, Virnig K, Hinkle R, Salmon CT: The Use of 0-10 Scales in Telephone Surveys. J Market Res Society, 29(3):353-362, 1987
citation: 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