- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00738231
Training Methods for a Doctrine Of Life With Healthy Heart
Two Distinct Training Methods for Healthy Heart in Low Social and Economical Society
This study is an interventional study which was conducted in the field. The investigators intended to develop an efficient and economically valuable method which can decrease the risk factors for prevention of cardiovascular diseases. Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and cheap methods to decrease risk factors.
In this study, the aim of preparing the Group II training material was to enable the individual to see his or her risks as unique, and to proceed with life by adapting personal behaviors. Group II's training material was formatted as a prescription. Because giving a prescription for a doctor is very important in low socioeconomical group person.
This study showed that social programs oriented towards individual behavioral changes assume an important role in decreasing cardiovascular risk factors.
Study Overview
Detailed Description
Background:
Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and economical methods to decrease risk factors.
Methods:
This study was conducted in three stages in a semi-rural region of Eskisehir, Turkey. In the first stage, individuals selected by random sampling were evaluated in terms of social-demographic characteristics and the risk factors present for cardiovascular diseases. A scale comprised of 19 questions was implemented for data assessment. In the second stage, training materials were randomly distributed. Group I's training material consisted of a brochure containing pictures and general information on heart disease; Group II members additionally received a personalized letter that further explained their individual risk factors and suggested measures for increased protection and prevention - in short, Group II's training material was formatted as a prescription. In the third stage, the subjects were screen against the cardiovascular risks factors one year later to assess and determine if there had been any changes in their attitudes towards the dangers of the cardiovascular diseases.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Eskisehir, Turkey, 26220
- ESOGU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over 40 years of age were contacted.
- Individuals who were literate or had at least one literate person in the household were selected through random sampling via the records of local health care units.
Exclusion Criteria:
- Under 40 years of age and immigrants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: I
Group I's training material consisted of a brochure with the information we wanted the public to know about heart disease.
The brochure had such titles as "Cardiovascular Diseases, let us protect our hearts, the importance of cholesterol in preventing heart diseases, watch out for blood pressure, quit smoking for your health, weight watching, nutrition, food to avoid in cardiovascular disease, an easy method: exercise and exercise control, and an appropriate body weight vs. height chart for adults"
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The training materials were randomly distributed to study participant groups.
The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures.
Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure.
Other Names:
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Active Comparator: II
The Group II training material document was a letter in the form of a prescription in which the individual was addressed by name, the risk factors established at the first stage were explained, and the suggested measures for protection from such risk factors were indicated.
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The training materials were randomly distributed to study participant groups.
The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures.
Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Increase of score of the knowledge about the risk factors for cardiovascular diseases
Time Frame: 1 month
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1 month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Stop smoking; to regulate of arterial tension; properly change of feeding behaviour
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Selma Metintas, MD,Prof., ESOGU
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007/37
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