Cardiovascular DiseasesNCT00005151
Pawtucket Heart Health Program
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1980to Jul 1997
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia, Hypertension, Obesity, Cerebrovascular Accident
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia, Hypertension, Obesity, Stroke, Coronary Disease, Atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startAug 1980
- Study completionJul 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (95)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005151
- Sponsor's protocol ID
- 1022
- Other IDs
- R01HL023629
- Status last verified
- Jul 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Gans KM, Lapane KL, Lasater TM, Carleton RA. Effects of intervention on compliance to referral and lifestyle recommendations given at cholesterol screening programs. Am J Prev Med. 1994 Sep-Oct;10(5):275-82.
PubMed 7848670Crowley JP, Metzger J, Assaf A, Carleton RC, Merrill E, Valeri CR. Low density lipoprotein cholesterol and whole blood viscosity. Ann Clin Lab Sci. 1994 Nov-Dec;24(6):533-41.
PubMed 7847781Derby CA, Hume AL, McPhillips JB, Barbour MM, Carleton RA. Prior and current health characteristics of postmenopausal estrogen replacement therapy users compared with nonusers. Am J Obstet Gynecol. 1995 Aug;173(2):544-50. doi: 10.1016/0002-9378(95)90280-5.
PubMed 7645633Carleton RA, Lasater TM, Assaf AR, Feldman HA, McKinlay S. The Pawtucket Heart Health Program: community changes in cardiovascular risk factors and projected disease risk. Am J Public Health. 1995 Jun;85(6):777-85. doi: 10.2105/ajph.85.6.777.
PubMed 7762709Carleton RA, Lasater TM, Assaf AR. The Pawtucket Heart Health Program: progress in promoting health. R I Med. 1995 Mar;78(3):74-7. No abstract available.
PubMed 7734757Derby 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.
PubMed 7880551Coronary-prone behavior and coronary heart disease: a critical review. The review panel on coronary-prone behavior and coronary heart disease. Circulation. 1981 Jun;63(6):1199-215. doi: 10.1161/01.cir.63.6.1199.
PubMed 7014026Thompson 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.
PubMed 6978411Siconolfi 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.
PubMed 7154887Carleton RA. Criterion for cholesterol norms--healthy or statistical? Am J Clin Pathol. 1983 Mar;79(3):402. doi: 10.1093/ajcp/79.3.402. No abstract available.
PubMed 6829508Carleton RA, Lasater TM. Coronary heart disease and human behavior. Prev Med. 1983 Sep;12(5):610-8. doi: 10.1016/0091-7435(83)90217-7.
PubMed 6657626Siconolfi SF, Carleton RA, Elder JP, Bouchard PA: Hypotension After Exercise and Relaxation. In: Canto RC (Ed), Clinical Sports Medicine, Collamore Press, Lexington, Mass, Chapter 11, 1983
Hume AL, Barbour MM, Willey CJ, Assaf AR, Lapane KL, Carleton RA. Changing trends in antihypertensive therapy in two New England communities during the 1980s. Pharmacotherapy. 1993 May-Jun;13(3):244-51.
PubMed 8100629McPhillips JB, Eaton CB, Gans KM, Derby CA, Lasater TM, McKenney JL, Carleton RA. Dietary differences in smokers and nonsmokers from two southeastern New England communities. J Am Diet Assoc. 1994 Mar;94(3):287-92. doi: 10.1016/0002-8223(94)90370-0.
PubMed 8120293Reynes JF, Lasater TM, Feldman H, Assaf AR, Carleton RA. Education and risk factors for coronary heart disease: results from a New England community. Am J Prev Med. 1993 Nov-Dec;9(6):365-71.
PubMed 8311986
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pawtucket Heart Health Program
- ClinicalTrials.gov ID
- NCT00005151
- Acronym / sponsor ID
- 1022
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia, Hypertension, Obesity, Cerebrovascular Accident
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1980
- Study completion
- Jul 1997 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 7848670Gans KM, Lapane KL, Lasater TM, Carleton RA. Effects of intervention on compliance to referral and lifestyle recommendations given at cholesterol screening programs. Am J Prev Med. 1994 Sep-Oct;10(5):275-82.
- Background: PubMed 7847781Crowley JP, Metzger J, Assaf A, Carleton RC, Merrill E, Valeri CR. Low density lipoprotein cholesterol and whole blood viscosity. Ann Clin Lab Sci. 1994 Nov-Dec;24(6):533-41.
- Background: PubMed 7645633Derby CA, Hume AL, McPhillips JB, Barbour MM, Carleton RA. Prior and current health characteristics of postmenopausal estrogen replacement therapy users compared with nonusers. Am J Obstet Gynecol. 1995 Aug;173(2):544-50. doi: 10.1016/0002-9378(95)90280-5.
- Background: PubMed 7762709Carleton RA, Lasater TM, Assaf AR, Feldman HA, McKinlay S. The Pawtucket Heart Health Program: community changes in cardiovascular risk factors and projected disease risk. Am J Public Health. 1995 Jun;85(6):777-85. doi: 10.2105/ajph.85.6.777.
- Background: PubMed 7734757Carleton RA, Lasater TM, Assaf AR. The Pawtucket Heart Health Program: progress in promoting health. R I Med. 1995 Mar;78(3):74-7. No abstract available.
- Background: PubMed 7880551Derby 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.
- Background: PubMed 7014026Coronary-prone behavior and coronary heart disease: a critical review. The review panel on coronary-prone behavior and coronary heart disease. Circulation. 1981 Jun;63(6):1199-215. doi: 10.1161/01.cir.63.6.1199.
- Background: PubMed 6978411Thompson 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.
- Background: PubMed 7154887Siconolfi 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.
- Background: PubMed 6829508Carleton RA. Criterion for cholesterol norms--healthy or statistical? Am J Clin Pathol. 1983 Mar;79(3):402. doi: 10.1093/ajcp/79.3.402. No abstract available.
- Background: PubMed 6657626Carleton RA, Lasater TM. Coronary heart disease and human behavior. Prev Med. 1983 Sep;12(5):610-8. doi: 10.1016/0091-7435(83)90217-7.
- BackgroundSiconolfi SF, Carleton RA, Elder JP, Bouchard PA: Hypotension After Exercise and Relaxation. In: Canto RC (Ed), Clinical Sports Medicine, Collamore Press, Lexington, Mass, Chapter 11, 1983
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005151, which also lists 95 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.