Clinical trial NCT00005151: Pawtucket Heart Health Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypercholesterolemia
Hypertension
Obesity
Cerebrovascular Accident
Coronary Disease
Atherosclerosis
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
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 community-based research and demonstration project in cardiovascular disease prevention in the town of Pawtucket, Rhode Island. Targeted risk factors included high blood pressure, elevated blood cholesterol, obesity, cigarette smoking, and sedentary living. To evaluate the program, risk factor surveys on a cross-sectional and cohort basis were conducted along with mortality and morbidity surveillance both in Pawtucket and in the non-intervention comparison town of New Bedford, Massachusetts.

Detailed description: BACKGROUND:

The Pawtucket Heart Health Program arose from a concern that the needs of society could not be met through palliative treatment of coronary heart disease. In 1977, a program designed to facilitate rehabilitation and, hopefully, to provide possible secondary preventive measures for patients with symptomatic coronary heart disease was begun. Simultaneously, the conviction grew that the national interest would be served by careful research into whether or not coronary heart disease was preventable through modification of those aspects of individual and group behavior which influenced the major cardiovascular risk factors in free living populations.

The Pawtucket Heart Health Program was designed to foster community ownership and active participation in a culture change process. A population-wide atherosclerosis risk factor reduction was anticipated as a result of applying an independent variable based upon Social Learning Theory. Emphases on individual factors, on physical environmental factors, and on sociocultural influences on behavior were designed to produce persisting risk factor change followed by morbidity - mortality rate reduction for the population of the city.

DESIGN NARRATIVE:

Selection of an intervention community and a control community was carried out early in the design of the Pawtucket Heart Health Program. Census data, as updated through 1975, were used to identify two communities with between 40,000 and 100,000 people and with stability of in-migration and out-migration necessary for long-term follow-up. The two communities were carefully matched for socio-demographic variables.

Both communities underwent baseline random-sample surveys which demonstrated similar levels of cardiovascular risk factors in the populations of each city. Effective community intervention began in 1983. Total intervention was 7.5 years. Specific objectives of the intervention included a six percent reduction in total cholesterol, a 6 mm Hg reduction in systolic blood pressure, a 30 percent relative reduction in active smokers, a two percent reduction in body weight and body mass index, a 2 ml/kg/minute increase in estimated maximal oxygen uptake, and a 15 percent reduction in fatal and non-fatal cardiovascular disease event rates. Educational techniques used by the program included: print, radio and televised messages; small group behavior change programs delivered by trained lay volunteers; community and worksite-based blood pressure reduction, cholesterol and multiple-risk factor screening, counseling and referral events; self-help programs; school curricula; smoking prevention programs; risk behavior change competitions; shelf-labeling in grocery stores and menu-labeling in restaurants to indicate low sodium and low fat foods.

The effectiveness of the program was evaluated by biennial random household risk factor surveys, a morbidity and mortality surveillance system and other methods. In the risk factor survey, households were randomly selected. Within each sampled household, a single respondent was selected from eligible adults. A household interview and testing protocol was administered in the home and includes questions about diet, exercise, smoking, behavior and knowledge of cardiovascular disease. Physiological measures included height, weight, blood pressure, total cholesterol, triglycerides, high-density-lipoprotein bound cholesterol and serum cotinine. A subsample was given a step test to estimate maximum oxygen uptake as a measure of fitness. A second subset completed a Willett diet questionnaire. There were five cross-sectional household surveys of approximately 2,800 individuals per survey. The initial cross-sectional survey was converted to a cohort survey for measurement again in 1986-1987 and in 1988-1989. The third cross-sectional survey was also converted to a cohort survey for simultaneous measurement with the 1987-1988 and 1989-1990 cross-sectional samples.

Both communities were screened for morbidity and case-fatality rates for coronary heart disease and stroke. Morbidity and mortality data were obtained from seven area hospitals and the State Health Departments of Rhode Island and Massachusetts. Outcome criteria were developed collaboratively by the Pawtucket Heart Health Program, the Stanford Five-City Multifactor Risk Reduction Study, and the Minnesota Heart Health Program, to maximize the scientific value of the conclusions drawn from the three studies and to allow pooling of final data. Surveillance was complete for 1980 to 1983 and continued through 1993.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Derby CA, Lasater TM, Vass K, Gonzalez S, Carleton RA. Characteristics of smokers who attempt to quit and of those who recently succeeded. Am J Prev Med. 1994 Nov-Dec;10(6):327-34.
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citation: Thompson PD, Funk EJ, Carleton RA, Sturner WQ. Incidence of death during jogging in Rhode Island from 1975 through 1980. JAMA. 1982 May 14;247(18):2535-8.
citation: Siconolfi SF, Cullinane EM, Carleton RA, Thompson PD. Assessing VO2max in epidemiologic studies: modification of the Astrand-Rhyming test. Med Sci Sports Exerc. 1982;14(5):335-8.
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citation: Barbour MM, Hume AL, Assaf AR, Carleton RA. The drug data base of the Pawtucket Heart Health Program: development and description. Pharmacotherapy. 1993 May-Jun;13(3):239-43.
citation: Derby CA, Hume AL, Barbour MM, McPhillips JB, Lasater TM, Carleton RA. Correlates of postmenopausal estrogen use and trends through the 1980s in two southeastern New England communities. Am J Epidemiol. 1993 May 15;137(10):1125-35. doi: 10.1093/oxfordjournals.aje.a116616.
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citation: Siconolfi SF, Carleton RA, Lasater TM: Relationship Between Physical Activity Questionnaire and Maximal Oxygen Uptake. Circulation, Supplement, October, 1984
citation: Sennett LL, Peterson G, Elder JP, Lasater TM, Carleton RA: A Community-Based Approach to Weight Loss: The Pawtucket 'Weigh-In.' Chapter in Clinical Sports Medicine, Third Edition, Canto RC (Ed), Collamore Press, Lexington, Mass, in Press, 1985
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citation: Siconolfi SF, Lasater TM, McKinlay S, Boggia P, Carleton RA. Physical fitness and blood pressure: the role of age. Am J Epidemiol. 1985 Sep;122(3):452-7. doi: 10.1093/oxfordjournals.aje.a114126.
citation: Siconolfi SF, Lasater TM, Snow RC, Carleton RA. Self-reported physical activity compared with maximal oxygen uptake. Am J Epidemiol. 1985 Jul;122(1):101-5. doi: 10.1093/oxfordjournals.aje.a114068.
citation: Siconolfi SF, Garber CE, Lasater TM, Carleton RA. A simple, valid step test for estimating maximal oxygen uptake in epidemiologic studies. Am J Epidemiol. 1985 Mar;121(3):382-90. doi: 10.1093/oxfordjournals.aje.a114010.
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citation: Schwertfeger R, Elder JP, Cooper R, Lasater TM, Carleton R. The use of telemarketing in the community-wide prevention of heart disease: the Pawtucket Heart Health Program. J Community Health. 1986 Fall;11(3):172-80. doi: 10.1007/BF01338798.
citation: Siconolfi SF, Lasater TM, Elder JP, Garber CE, Carleton RA: Normal Blood Pressure Reactivity to Mental Stress in Borderline Hypertensive Patients. J Cardiac Rehab, 6:383-398, 1986
citation: Lefebvre RC, Peterson GS, McGraw SA, Lasater TM, Sennett L, Kendall L, Carleton RA. Community intervention to lower blood cholesterol: the "Know Your Cholesterol" campaign in Pawtucket, Rhode Island. Health Educ Q. 1986 Summer;13(2):117-29. doi: 10.1177/109019818601300202.
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citation: Lasater TM, Lefebvre RC, Assaf AR, Saritelli AL, Carleton RA. Rapid measurement of blood cholesterol: evaluation of a new instrument. Am J Prev Med. 1987 Nov-Dec;3(6):311-6.
citation: Lefebvre RC, Harden EA, Rakowski W, Lasater TM, Carleton RA. Characteristics of participants in community health promotion programs: four-year results. Am J Public Health. 1987 Oct;77(10):1342-4. doi: 10.2105/ajph.77.10.1342.
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citation: Carleton RA, Lasater TM, Assaf A, Lefebvre RC, McKinlay SM. The Pawtucket Heart Health Program: I. An experiment in population-based disease prevention. R I Med J (1976). 1987 Dec;70(12):533-8. No abstract available.
citation: Colby JJ, Elder JP, Peterson G, Knisley PM, Carleton RA. Promoting the selection of healthy food through menu item description in a family-style restaurant. Am J Prev Med. 1987 May-Jun;3(3):171-7.
citation: Lefebvre RC, Lasater TM, Assaf AR, Carleton RA. Pawtucket Heart Health Program: the process of stimulating community change. Scand J Prim Health Care Suppl. 1988;1:31-7.
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citation: Lefebvre RC, Hursey KG, Carleton RA. Labeling of participants in high blood pressure screening programs. Implications for blood cholesterol screenings. Arch Intern Med. 1988 Sep;148(9):1993-7.
citation: Lefebvre RC, Lasater TH, McKinlay SM, Gans KM, Walker N, Carleton RA. Performance characteristics of a blood cholesterol measuring instrument used in screening programs. Public Health Rep. 1989 May-Jun;104(3):266-70.
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citation: Gans KM, Levin S, Lasater TM, Sennett LL, Maroni A, Ronan A, Carleton RA. Heart healthy cook-offs in home economics classes: an evaluation with junior high school students. J Sch Health. 1990 Mar;60(3):99-102. doi: 10.1111/j.1746-1561.1990.tb05409.x.
citation: Lefebvre RC, Gubata P, Ronan A, Carleton RA. Variation in the Reflotron method of cholesterol measurement. Am J Cardiol. 1990 Apr 1;65(13):916-7. doi: 10.1016/0002-9149(90)91437-b. No abstract available.
citation: Hunt MK, Lefebvre RC, Hixson ML, Banspach SW, Assaf AR, Carleton RA. Pawtucket Heart Health Program point-of-purchase nutrition education program in supermarkets. Am J Public Health. 1990 Jun;80(6):730-2. doi: 10.2105/ajph.80.6.730.
citation: Linnan LA, Harden EA, Bucknam L, Carleton RA. Marketing cardiovascular disease risk reduction programs at the workplace. The Pawtucket Heart Health Program experience. AAOHN J. 1990 Sep;38(9):409-18.
citation: Rakowski W, Lefebvre RC, Assaf AR, Lasater TM, Carleton RA. Health practice correlates in three adult age groups: results from two community surveys. Public Health Rep. 1990 Sep-Oct;105(5):481-91.
citation: Lefebvre RC, Cobb GD, Goreczny AJ, Carleton RA. Efficacy of an incentive-based community smoking cessation program. Addict Behav. 1990;15(5):403-11. doi: 10.1016/0306-4603(90)90026-t.
citation: Linnan LA, Gans KM, Hixson ML, Mendes E, Longpre H, Carleton RA. Training health professionals and lay volunteers to deliver cholesterol screening and education programs. Public Health Rep. 1990 Nov-Dec;105(6):589-98.
citation: Rakowski W, Assaf AR, Lefebvre RC, Lasater TM, Niknian M, Carleton RA. Information-seeking about health in a community sample of adults: correlates and associations with other health-related practices. Health Educ Q. 1990 Winter;17(4):379-93. doi: 10.1177/109019819001700403.
citation: Assaf AR, Banspach SW, Lasater TM, Ramsey J, Tidwell RJ, Carleton RA. The FPbase microcomputer system for managing community health screening and intervention data bases. Public Health Rep. 1992 Nov-Dec;107(6):695-700.
citation: DelPrete LR, Caldwell M, English C, Banspach SW, Lefebvre C. Self-reported and measured weights and heights of participants in community-based weight loss programs. J Am Diet Assoc. 1992 Dec;92(12):1483-6.
citation: Jack BW, Gans KM, McQuade W, Culpepper L, Lasswell A, Hume AL, Dowling PT, Carleton RA. A successful physician training program in cholesterol screening and management. Prev Med. 1991 May;20(3):364-77. doi: 10.1016/0091-7435(91)90035-3.
citation: Lasater TM, Sennett LL, Lefebvre RC, DeHart KL, Peterson G, Carleton RA. Community-based approach to weight loss: the Pawtucket "weigh-in". Addict Behav. 1991;16(3-4):175-81. doi: 10.1016/0306-4603(91)90010-f.
citation: Carleton RA, Sennett L, Gans KM, Levin S, Lefebvre C, Lasater TM. The Pawtucket Heart Health Program. Influencing adolescent eating patterns. Ann N Y Acad Sci. 1991;623:322-6. doi: 10.1111/j.1749-6632.1991.tb43741.x.
citation: Niknian M, Linnan LA, Lasater TM, Carleton RA. Use of population-based data to assess risk factor profiles of blue and white collar workers. J Occup Med. 1991 Jan;33(1):29-36. doi: 10.1097/00043764-199101000-00010.
citation: Niknian M, Lefebvre RC, Carleton RA. Are people more health conscious? A longitudinal study of one community. Am J Public Health. 1991 Feb;81(2):205-7. doi: 10.2105/ajph.81.2.205.
citation: Eaton CB, Lapane KL, Garber CA, Assaf AR, Lasater TM, Carleton RA. Sedentary lifestyle and risk of coronary heart disease in women. Med Sci Sports Exerc. 1995 Nov;27(11):1535-9.
citation: McKenney JL, Lapane KL, Assaf AR, Carleton RA. The association between perceived risk and actual cardiovascular disease. Epidemiology. 1995 Nov;6(6):612-6. doi: 10.1097/00001648-199511000-00009.
citation: Assaf AR, Helmert U, Lasater TL, Carleton RA, Greiser E. Measuring cardiovascular disease risk factor levels: international comparisons between Bremen-north/west (Germany) and two southeastern New England (USA) cities. Soz Praventivmed. 1995;40(4):218-29. doi: 10.1007/BF01354476.
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citation: Lapane KL, Zierler S, Lasater TM, Barbour MM, Carleton R, Hume AL. Is the use of psychotropic drugs associated with increased risk of ischemic heart disease? Epidemiology. 1995 Jul;6(4):376-81. doi: 10.1097/00001648-199507000-00008.
citation: Derby CA, Feldman HA, Bausserman LL, Parker DR, Gans KM, Carleton RA. HDL cholesterol: trends in two southeastern New England communities, 1981-1993. Ann Epidemiol. 1998 Feb;8(2):84-91. doi: 10.1016/s1047-2797(97)00130-0.
citation: Winkleby MA, Feldman HA, Murray DM. Joint analysis of three U.S. community intervention trials for reduction of cardiovascular disease risk. J Clin Epidemiol. 1997 Jun;50(6):645-58. doi: 10.1016/s0895-4356(97)00020-6.
citation: Parker DR, Gonzalez S, Derby CA, Gans KM, Lasater TM, Carleton RA. Dietary factors in relation to weight change among men and women from two southeastern New England communities. Int J Obes Relat Metab Disord. 1997 Feb;21(2):103-9. doi: 10.1038/sj.ijo.0800373.
citation: Derby CA, Lapane KL, Hume AL, Babour MM, Carleton RA. Is cigarette smoking an effect modifier of the relation between antihypertensive therapy and blood lipids? Epidemiology. 1997 Jan;8(1):48-54. doi: 10.1097/00001648-199701000-00008.
citation: Hume AL, Barbour MM, Lapane KL, Flint PM, Carleton RA. Correlates of oral contraceptive use in two New England communities: 1981-1993. Pharmacotherapy. 1996 Nov-Dec;16(6):1173-8.
citation: Parker DR, Derby CA, Usner DW, Gonzalez S, Lapane KL, Carleton RA. Self-reported alcohol intake using two different question formats in southeastern New England. Int J Epidemiol. 1996 Aug;25(4):770-4. doi: 10.1093/ije/25.4.770.
citation: Parker DR, McPhillips JB, Lapane KL, Lasater TM, Carleton RA. Nutrition and health practices of diabetic and nondiabetic men and women from two southeastern New England communities. Nutr Health. 1995;10(3):255-68. doi: 10.1177/026010609501000309.
citation: Parker DR, McPhillips JB, Derby CA, Gans KM, Lasater TM, Carleton RA. High-density-lipoprotein cholesterol and types of alcoholic beverages consumed among men and women. Am J Public Health. 1996 Jul;86(7):1022-7. doi: 10.2105/ajph.86.7.1022.
citation: Flint PM, Lapane KL, Barbour MM, Derby CA, Carleton RA, Hume AL. Cardiovascular risk profiles of oral contraceptive users and nonusers: a population-based study. Prev Med. 1995 Nov;24(6):586-90. doi: 10.1006/pmed.1995.1093.
citation: Lapane KL, Zierler S, Lasater TM, Stein M, Barbour MM, Hume AL. Is a history of depressive symptoms associated with an increased risk of infertility in women? Psychosom Med. 1995 Nov-Dec;57(6):509-13; discussion 514-6. doi: 10.1097/00006842-199511000-00001.
citation: Assaf AR, Lapane KL, McKenney JL, McKinlay S, Carleton RA. Coronary heart disease surveillance: field application of an epidemiologic algorithm. J Clin Epidemiol. 2000 Apr;53(4):419-26. doi: 10.1016/s0895-4356(99)00183-3.
citation: Derby CA, Lapane KL, Feldman HA, Carleton RA. Trends in validated cases of fatal and nonfatal stroke, stroke classification, and risk factors in southeastern New England, 1980 to 1991 : data from the Pawtucket Heart Health Program. Stroke. 2000 Apr;31(4):875-81. doi: 10.1161/01.str.31.4.875.
citation: Derby CA, Lapane KL, Feldman HA, Carleton RA. Sex-specific trends in validated coronary heart disease rates in southeastern New England, 1980-1991. Am J Epidemiol. 2000 Feb 15;151(4):417-29. doi: 10.1093/oxfordjournals.aje.a010222.
citation: Eaton CB, Lapane KL, Garber CE, Gans KM, Lasater TM, Carleton RA. Effects of a community-based intervention on physical activity: the Pawtucket Heart Health Program. Am J Public Health. 1999 Nov;89(11):1741-4. doi: 10.2105/ajph.89.11.1741.
citation: Gans KM, Assmann SF, Sallar A, Lasater TM. Knowledge of cardiovascular disease prevention: an analysis from two New England communities. Prev Med. 1999 Oct;29(4):229-37. doi: 10.1006/pmed.1999.0532.
citation: Parker DR, Lapane KL, Lasater TM, Carleton RA. Short stature and cardiovascular disease among men and women from two southeastern New England communities. Int J Epidemiol. 1998 Dec;27(6):970-5. doi: 10.1093/ije/27.6.970.