Protocol summary

Study aim
the effect of life style education based on pender model on promotion of health behaviors in patients with HIV
Design
In this research, 70 eligible patients referring to center of behavioral diseases were chosen purposefully and a cod was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
The setting of research was center of behavioral diseases in the south of Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age above than 18, minimum literacy, at least 6 months after diagnosis Exclusion criteria: having physical or mental disorders
Intervention groups
First, patients in both groups were invited separately to explanatory session. Then the experimental group received a weekly educational course of six one-hour sessions consisting Pender lifestyle contents (nutrition, physical activity, stress management, moral growth, interpersonal relationship, responsibility health) which has been based on the most recent sources. The material used in this study was the questioner HPLP2 which was completed by the patients before the intervention had started and then again eight weeks after it finished. Control group has a routine care in center.
Main outcome variables
Education based on the Pender model promotes the adoption of health promoting behaviors from HIV patients, which is suggested as an effective program for managers and healthcare providers.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170121032095N1
Registration date: 2017-12-25, 1396/10/04
Registration timing: retrospective

Last update: 2017-12-25, 1396/10/04
Update count: 0
Registration date
2017-12-25, 1396/10/04
Registrant information
Name
Shahzad Pashaeipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4208
Email address
sh-pashaeipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-04-25, 1396/02/05
Expected recruitment end date
2017-08-28, 1396/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of lifestyle education based on Pender’s model on health promoting behaviors in people living with HIV
Public title
effects of lifestyle education on health promoting behaviors in people living with HIV
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
over than 18 years old minimum literacy at least 6 months after diagnosis
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
colored pocket: red and blue
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IR.TUMS.FNM.REC.1395.1296

Health conditions studied

1

Description of health condition studied
HIV
ICD-10 code
B20
ICD-10 code description
Human Immunodeficiency Virus

Primary outcomes

1

Description
Health promotion behavior
Timepoint
before and 8 weeks after intervention
Method of measurement
scale

Secondary outcomes

empty

Intervention groups

1

Description
lifestyle education based on Pender’s model
Category
Lifestyle

2

Description
Control group: Traditional education in health center
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
behavioral control center
Full name of responsible person
shahzad pashaeypoor
Street address
school of nursing and midwifery, TUMS, Nosrat St
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8105 4208
Email
sh-pashaeipour@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
TUMS
Full name of responsible person
Kardan
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3605
Email
sh-pashaeipour@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
TUMS
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaeipour
Position
Assisstant prof
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4208
Fax
Email
sh-pashaeipour@sina.tuma.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaeipour
Position
Assisstant prof
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4208
Fax
Email
sh-pashaeipour@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaeipour
Position
Assisstant Prof
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
Iran
Phone
+98 21 6105 4208
Fax
Email
sh-pashaeipour@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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