Pawtucket Heart Health Program

Obesity Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

N/A

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Cerebrovascular Accident
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypercholesterolemia
• Hypertension
• Obesity
• Stroke

• NCT number: NCT00005151
• Study type: Observational
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Status: Completed
• Phase: N/A
• Start date: August 1980
• Completion date: July 1997