Methods of sampling and sample size determination of a comprehensive integrated community-based interventional trial: Isfahan Healthy Heart Program

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Abstract

BACKGROUND

The aim of this study was describing the sampling methods and sample size of the Isfahan Healthy Heart Program (IHHP) and its sub-studies in focus.

METHODS

The IHHP was carried out between 2000 and 2007 in urban and rural areas in 3 districts, namely Isfahan and Najafabad (as the intervention areas), and Arak (as the reference area), Iran. It consisted of the 3 phases of baseline surveys during 2000-2001, interventions between 2002 and 2005, and post-intervention surveys during 2006-2007 on 4 target groups (adults, health professionals, cardiac patients, children, and adolescents). During 2002 to 2005, 4 evaluation studies were conducted to evaluate short-term results. An ongoing cohort study entitled the Isfahan Cohort Study was performed on those aged ≥ 35 years at baseline in 2001 to access the risk of cardiovascular disease (CVD) occurrence.

RESULTS

Using stratified random cluster methods, 12514, 5891, 4793, 6096, 3012, and 9572 adults and 1946, 1999, 1427, 1223, 389, and 1992 adolescents were chosen in the 1st to 3rd phases. Furthermore, simple random sampling was used for selecting 923, 694, 1000, and 2015 health professionals and 814, 452, 420, and 502 cardiac patients. A multistage sampling method was adopted for the collection of samples from parents of preschoolers and primary school children aged 2-10 years, adolescents’ parents, and some teachers. A prospective cohort study was started on 6504 eligible individuals.

CONCLUSION

The IHHP, as a comprehensive community-based interventional trial in Iran, among the few population-based studies around the world, has reasonable sampling methods and sample size.

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Most cited references 39

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Prevention of non-communicable disease in a population in nutrition transition: Tehran Lipid and Glucose Study phase II

Fereidoun Azizi, Arash Ghanbarian, Amir Momenan … (2009)

Background The Tehran Lipid and Glucose Study (TLGS) is a long term integrated community-based program for prevention of non-communicable disorders (NCD) by development of a healthy lifestyle and reduction of NCD risk factors. The study begun in 1999, is ongoing, to be continued for at least 20 years. A primary survey was done to collect baseline data in 15005 individuals, over 3 years of age, selected from cohorts of three medical heath centers. A questionnaire for past medical history and data was completed during interviews; blood pressure, pulse rate, and anthropometrical measurements and a limited physical examination were performed and lipid profiles, fasting blood sugar and 2-hours-postload-glucose challenge were measured. A DNA bank was also collected. For those subjects aged over 30 years, Rose questionnaire was completed and an electrocardiogram was taken. Data collected were directly stored in computers as database software- computer assisted system. The aim of this study is to evaluate the feasibility and effectiveness of lifestyle modification in preventing or postponing the development of NCD risk factors and outcomes in the TLGS population. Design and methods In phase II of the TLGS, lifestyle interventions were implemented in 5630 people and 9375 individuals served as controls. Primary, secondary and tertiary interventions were designed based on specific target groups including schoolchildren, housewives, and high-risk persons. Officials of various sectors such as health, education, municipality, police, media, traders and community leaders were actively engaged as decision makers and collaborators. Interventional strategies were based on lifestyle modifications in diet, smoking and physical activity through face-to-face education, leaflets & brochures, school program alterations, training volunteers as health team and treating patients with NCD risk factors. Collection of demographic, clinical and laboratory data will be repeated every 3 years to assess the effects of different interventions in the intervention group as compared to control group. Conclusion This controlled community intervention will test the possibility of preventing or delaying the onset of non-communicable risk factors and disorders in a population in nutrition transition. Trial registration ISRCTN52588395

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Isfahan Healthy Heart Programme: a comprehensive integrated community-based programme for cardiovascular disease prevention and control. Design, methods and initial experience.

Alireza Yousefie, Tahereh Changiz, Masoud Poormoghaddas … (2003)

The Isfahan Healthy Heart Programme (IHHP) is a five to six year comprehensive integrated community-based programme for cardiovascular diseases (CVD) prevention and control via reducing CVD risk factors and improvement of cardiovascular healthy behaviour in a target population. IHHP started late in 1999 and will be finished in 2005-2006. A primary survey was done to collect baseline data from interventional (Isfahan and Najaf-Abad) and reference (Arak) communities. In a two-stage sampling method, we randomly selected 5 to 10 percent of households from randomly selected clusters. Then individuals aged > or = 19 years were selected for the survey. This way, data from 12,600 individuals (6300 in interventional counties and 6300 in the reference county) was collected and stratified according to living area (urban vs. rural) and different age and sex groups. The samples underwent a 30-minute interview to complete validated questionnaires containing questions on demography, socioeconomic status, smoking behaviour, physical activity, nutritional habits and other behaviour regarding CVD. Blood pressure and body mass index (BMI) measurements were done and fasting blood samples were taken for two hours post load plasma glucose (2 hpp), serum (total, HDL and LDL) cholesterol and triglyceride levels. A twelve-lead electrocardiogram was recorded in all persons above 35 years of age. Community-wide surveillance of deaths, hospital discharges, myocardial infarction and stroke registry was carried out in the intervention and control areas. Four to five years of interventions based on different categories such as mass media, community partnerships, health system involvement and policy and legislation have started in the intervention area while Arak will be followed without intervention. Considering the results of the baseline surveys, (assessments needed, the objectives, existing resources and the possibility of national implementation) the interventions were planned. They were set based on specific target groups like school children, women, work-site, health personnel, high-risk persons, and community leaders were actively engaged as decision makers. A series of teams was arranged for planning and implementation of the intervention strategies. Monitoring will be done on small samples to assess the effect of different interventions in the intervention area. While four periodic surveys will be conducted on independent samples to assess health behaviours related to CVD risk factors in the intervention and reference areas, the original pre-intervention subjects aged more than 35 years will be followed in both areas to assess the individual effect of interventions and outcomes like sudden death, fatal and nonfatal MI and stroke. The whole baseline survey will be repeated on the original and an independent sample in both communities at the end of the study.

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Incidence of cardiovascular diseases in an Iranian population: the Isfahan Cohort Study.

Nizal Sarrafzadegan, Masoumeh Sadeghi, Shahram Oveisgharan … (2013)

Accurate estimates of the incidence of cardiovascular diseases (CVD) comprising of acute myocardial infarction (AMI), unstable angina pectoris (UAP), sudden cardiac death (SCD), and stroke are very important for public health. However, such information is scarce, especially for middle- and low-income countries. The Isfahan Cohort Study (ICS) prospectively followed up 6504 individuals, 51.8% women, aged 35 years and over, 6323 initially free of CVD, from urban and rural areas in three districts in central Iran including Isfahan, Najafabad, and Arak. A panel of specialists in cardiology and neurology decided on the diagnosis of the occurred events based on patients' hospital records, verbal autopsy, and death certificates. After 32893 person-years of follow-up, 427 new cases of CVD events (229 in men) were registered. Confirmed cases of AMI, stroke, UAP, and SCD were 57, 43, 93, and 36 in men and 32, 48, 100, and 18 in women, respectively. The corresponding crude incidence rates were 352, 265, 352, and 220 per 100000 person-years in men and 186, 279, 584, and 104 in women, respectively. No significant differences were found in age at the time of events occurrence between men and women and between different event types except for SCD and stroke in women that in average the former occurred nine years later. CVD mortality rate was 331 per 100000 person-years in men and 203 in women. We found substantially high incidence rates for almost all CVDs and mortality. These findings need urgent consideration by health policy makers specifically for women.

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Author and article information

Journal

Journal ID (nlm-ta): ARYA Atheroscler

Journal ID (iso-abbrev): ARYA Atheroscler

Journal ID (publisher-id): ARYA

Title: ARYA Atherosclerosis

Publisher: Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences

ISSN (Print): 1735-3955

ISSN (Electronic): 2251-6638

Publication date (Print): March 2018

Volume: 14

Issue: 2

Pages: 58-70

Affiliations

[1 ]PhD Candidate, Isfahan Cardiovascular Research Center AND Interventional Cardiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran

[2 ]Professor, Cardiac Rehabilitation Research Center, Cardiovascular Research Institute AND Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran

[3 ]Heart Failure Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran

[4 ]Professor, Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran

Author notes

Correspondence to: Awat Feizi , Email: awat_feiz@ 123456hlth.mui.ac.ir AND Nizal Sarrafzadegan, Email: nsarrafzadegan@ 123456gmail.com

Article

Publisher ID: ARYA-14-058

DOI: 10.22122/arya.v14i2.1488

PMC ID: 6087631

SO-VID: 7bde4ed2-7ffc-412f-9c1c-87b4fa7c2546

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This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License which allows users to read, copy, distribute and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited properly.

Methods of sampling and sample size determination of a comprehensive integrated community-based interventional trial: Isfahan Healthy Heart Program

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Abstract

BACKGROUND

METHODS

RESULTS

CONCLUSION

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Most cited references 39

Prevention of non-communicable disease in a population in nutrition transition: Tehran Lipid and Glucose Study phase II

Isfahan Healthy Heart Programme: a comprehensive integrated community-based programme for cardiovascular disease prevention and control. Design, methods and initial experience.

Incidence of cardiovascular diseases in an Iranian population: the Isfahan Cohort Study.

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