Protocol summary

Summary
Objectives: The present study investigates the effectiveness of motivational interviewing in treating overweight and obesity among patients with coronary artery disease. Method: Using Quasi experimental, pretest- posttest design with control group, 110 patients who has previously Coronary Artery Bypass Grafting (CABG) are selected and assigned to two groups: experimental (n=60) and control (n=50) groups. These two groups will score on Body Mass Index (BMI) equal or above 25. The experimental group participates in motivational interviewing sessions in addition to regular cardiac rehabilitation programs. BMI, symptomatic depression, anxiety and stress were assessed in pretest and posttest (after three months). Data are analyzed using repeated measures analysis of variance regarding criteria of BMI for overweight and obesity. Results: Motivational Interviewing will be effective in controlling overweight and obesity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112108358N1
Registration date: 2012-02-01, 1390/11/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-01, 1390/11/12
Registrant information
Name
Yadollah Ghasemipour
Name of organization / entity
Malayer University
Country
Iran (Islamic Republic of)
Phone
+98 85 1224 0359
Email address
y.ghasemipour@malayeru.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Heart Center
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-02-19, 1389/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of motivational interviewing in treating overweight and obesity of patients with coronary artery disease
Public title
The effectiveness of motivational interviewing in Coronary Artery Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Incusion criteria: Having BMI equal and over 25; Being under coronary artery bypass grafting; Having ability to participate motivational interveiwing sessions; Having at least primery school degree Exclusion criteria: Disorders of axis I and II in DSM-IV; Diseadse related to obesity such as tyroid malfunctions
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University
Street address
Faculty of psychology and educational science, Opposite of Nasr Avenue Ave, Jalal Aal Ahmad highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2010-01-21, 1388/11/01
Ethics committee reference number
217

Health conditions studied

1

Description of health condition studied
Coronary Heart Disease
ICD-10 code
125.1
ICD-10 code description
Coronary artery disease

Primary outcomes

1

Description
Over weight
Timepoint
pretest- Three months later post-test
Method of measurement
Using standard rule and scale

2

Description
Obesity
Timepoint
pretest- Three months later post-test
Method of measurement
Using standard rule and scale

Secondary outcomes

1

Description
Depression
Timepoint
Depression
Method of measurement
Depression

2

Description
Anxiety
Timepoint
Anxiety
Method of measurement
Anxiety

3

Description
Stress
Timepoint
Stress
Method of measurement
Stress

Intervention groups

1

Description
In intervention group 4 sessions of Motivational Interviewing adminstred in 8-15 participants groups. Each session lasted 2 hours and the sessions adminestered in 2 days interval.
Category
Lifestyle

2

Description
Control group was in regular process of the hospital and just performed pre-test and post- test simoltaniously with Intervention group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Saeed Sadeghian MD
Street address
Next to the Shariati Hospital, North Kargar Cross, Jalal Aal Ahmad Highway, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Yadollah Ghasemipour
Street address
Malayer Uivesity, 4th kiloeter of Arak Road, Malayer, Hamedan, Iran.
City
Malayer
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Heart Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Malayer University
Full name of responsible person
Yadollah Ghasemipour
Position
Lecturer
Other areas of specialty/work
Street address
Malayer university, 4th km of Arak Road, Malayer, Hamedan, Iran
City
Malayer
Postal code
Phone
+98 85 1224 0359
Fax
+98 85 1333 9184
Email
y.ghasemipour@malayeru.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Malayer University
Full name of responsible person
Yadolllah Ghasemipour
Position
Lecturer
Other areas of specialty/work
Street address
Malayer University, 4th km of Arak Road, Malayer, Hamedan, Iran
City
Malayer
Postal code
Phone
+98 85 1224 0359
Fax
Email
y.ghasemipour@malayeru.ac.irghasemipour14@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Malayer Uniersity
Full name of responsible person
Yadollah Ghasemipour
Position
Lecturer
Other areas of specialty/work
Street address
Faculty of litreture and humanity science, Malayer University, 4th km of Arak Road, Malayer, Hamedan, Iran
City
Malayer
Postal code
Iran
Phone
+98 85 1224 0359
Fax
Email
y.ghasemipour@malayer.ac.irghasemipour14@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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