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Pawtucket Heart Health Program

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
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
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005151
    Brief Title
    Pawtucket Heart Health Program
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    July 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1980 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 1997 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

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

    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

    Citations:
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    8317442
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    8477120
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    Hume AL, Barbour MM, Lapane KL, Assaf AR, Carleton RA. Prevalence and descriptors of aspirin use as an antiplatelet agent in two New England communities. Ann Pharmacother. 1993 Apr;27(4):442-4. doi: 10.1177/106002809302700409.
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    Niknian M, McKinlay SM, Rakowski W, Carleton RA. A comparison of perceived and objective CVD risk in a general population. Am J Public Health. 1989 Dec;79(12):1653-4. doi: 10.2105/ajph.79.12.1653.
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    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.
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    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.
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    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.
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    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.
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    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.
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    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.
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    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.
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    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.
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    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.
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    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.
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    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.
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    PubMed Identifier
    1995799
    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.
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    1990861
    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.
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