Training Methods for a Doctrine Of Life With Healthy Heart

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT00738231
First received: August 19, 2008
Last updated: June 18, 2009
Last verified: August 2008
  Purpose

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.


Condition Intervention
Heart Diseases
Behavioral: Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Two Distinct Training Methods for Healthy Heart in Low Social and Economical Society

Resource links provided by NLM:


Further study details as provided by Eskisehir Osmangazi University:

Primary Outcome Measures:
  • Increase of score of the knowledge about the risk factors for cardiovascular diseases [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stop smoking; to regulate of arterial tension; properly change of feeding behaviour [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 498
Study Start Date: September 2007
Estimated Study Completion Date: December 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"
Behavioral: Training
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 Name: CAHD; TM
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.
Behavioral: Training
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 Name: CAHD; TM

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738231

Locations
Turkey
ESOGU
Eskisehir, Turkey, 26220
Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
Study Chair: Selma Metintas, MD,Prof. ESOGU
  More Information

Additional Information:
No publications provided

Responsible Party: Selma Metintas, MD, PhD, ESOGU
ClinicalTrials.gov Identifier: NCT00738231     History of Changes
Other Study ID Numbers: 2007/37
Study First Received: August 19, 2008
Last Updated: June 18, 2009
Health Authority: Turkey: Ministry of Health

Keywords provided by Eskisehir Osmangazi University:
risk factors; coronary arterial hearth disease

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014