NCT00738231

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
498

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 19, 2009

Status Verified

August 1, 2008

Enrollment Period

8 months

First QC Date

August 19, 2008

Last Update Submit

June 18, 2009

Conditions

Keywords

risk factors; coronary arterial hearth disease

Outcome Measures

Primary Outcomes (1)

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

    1 month

Secondary Outcomes (1)

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

    1 year

Study Arms (2)

I

ACTIVE COMPARATOR

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

II

ACTIVE COMPARATOR

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

Interventions

TrainingBEHAVIORAL

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.

Also known as: CAHD; TM
I

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Under 40 years of age and immigrants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ESOGU

Eskişehir, 26220, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Selma Metintas, MD,Prof.

    ESOGU

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

September 1, 2007

Primary Completion

May 1, 2008

Study Completion

December 1, 2009

Last Updated

June 19, 2009

Record last verified: 2008-08

Locations