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Training Methods for a Doctrine Of Life With Healthy Heart

Primary Purpose

Heart Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Training
Training
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Diseases focused on measuring risk factors; coronary arterial hearth disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ESOGU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

I

II

Arm Description

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"

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.

Outcomes

Primary Outcome Measures

Increase of score of the knowledge about the risk factors for cardiovascular diseases

Secondary Outcome Measures

Stop smoking; to regulate of arterial tension; properly change of feeding behaviour

Full Information

First Posted
August 19, 2008
Last Updated
June 18, 2009
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT00738231
Brief Title
Training Methods for a Doctrine Of Life With Healthy Heart
Official Title
Two Distinct Training Methods for Healthy Heart in Low Social and Economical Society
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
Keywords
risk factors; coronary arterial hearth disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
498 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
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"
Arm Title
II
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training
Other Intervention Name(s)
CAHD; TM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training
Other Intervention Name(s)
CAHD; TM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase of score of the knowledge about the risk factors for cardiovascular diseases
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Stop smoking; to regulate of arterial tension; properly change of feeding behaviour
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selma Metintas, MD,Prof.
Organizational Affiliation
ESOGU
Official's Role
Study Chair
Facility Information:
Facility Name
ESOGU
City
Eskisehir
ZIP/Postal Code
26220
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://www.ogu.edu.tr/
Description
Eskisehir Osmangazi University

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Training Methods for a Doctrine Of Life With Healthy Heart

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