The purpose of this study is to evaluate the impact ofa model based intervention on lifestyle among adolescents with beta-thalassemia.
Study population: adolescents 17 to 20 years of hospital records in thalassemia center in Ahvaz city.
Inclusion criteria: Adolescent lives in Ahvaz.
Adolescent agreed to participate in the study
Exclusion criteria:Adolescent doesn’t participate in a training session.
This study is a randomized controlled clinical trial for assessing the effect of training intervention on 60 adolescents with beta-thalassemia was designed.Health-promoting lifestyle profile II (HPLP II), a self-administered questionnaire base on the PRECEDE-PROCEED mode land a demographic scale will be used for data collection. Intervention is done in six 60 minute sessions. Data will be collected before and after intervention and one month after the intervention.
Expected outcomes of this study is improving the lifestyle of adolescents with beta-thalassemia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011125954N3
Registration date:2016-02-05, 1394/11/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-05, 1394/11/16
Registrant information
Name
Malihe Bazpoor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3477
Email address
bazpoor.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-02-03, 1394/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of a training program based on the PRECEDE -PROCEED Model onlifestyle of adolescents with beta thalassemia.
Public title
Assessing the effect of a training program based on the PRECEDE -PROCEED Model on lifestyle of adolescents with beta thalassemia.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Adolescent lives in Ahvaz.
Adolescent agreed to participate in the study
Exclusion criteria:Adolescent doesn’t participate in a training session.
Age
From 17 years old to 20 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences.
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
City
Ahwaz
Postal code
6135715794
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.AJUMS.RES.1394.507
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D63.8
ICD-10 code description
Anaemia in chronic diseases classified elsewhere
Primary outcomes
1
Description
life style
Timepoint
before intervention, after intervention, one month after the intervention.
Method of measurement
Health Promotion Lifestyle Profile
Secondary outcomes
1
Description
predisponsing, reinforsing and enabling factor
Timepoint
before intervention, after intervention and one month after the intervention.
Method of measurement
a self-administered questionnaire base on the PRECEDE-PROCEED model
Intervention groups
1
Description
case group: Intervention is training about dimension of lifestyle. Intervention training is a lecture and group discussion. Training sessions is done at 6 sessions . Each session is 60 minutes. Sessions to be held once a week.
Category
Lifestyle
2
Description
control group:no intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University ofMedical Sciences
Full name of responsible person
Bazpoor Malihe
Street address
Thalassemia Center hospital in Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University ofMedical Sciences
Full name of responsible person
Ghadiri Ataolah
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University ofMedical Sciences
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
Ahvaz university of medical sciences
Full name of responsible person
Malihe Bazpoor
Position
Masters student nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapur University ofMedical Sciences, Ahvaz, Iran.
City
Ahvaz
Postal code
Phone
+98 61 3333 3477
Fax
Email
bazpoor.m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences.
Full name of responsible person
Gheibizadeh Mahin
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 3477
Fax
Email
geibizadeh-m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Bazpoor Malihe
Position
Masters student nursing
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)