The effect of the theory-based educational intervention on improving mental and objective physical activity and loss weight and BMI in women with polycystic ovary syndrome
Design
parallel controlled trial study
Settings and conduct
Mahdieh hospital in Tehran
Participants/Inclusion and exclusion criteria
inclusion:Women aged 18-40 years with polycystic ovary syndrome
exclusion;Pregnancy and lactation,smokers
Intervention groups
Educational intervention and pedometer
Main outcome variables
physical activity - steps-weight-BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161116030923N3
Registration date:2018-01-24, 1396/11/04
Registration timing:retrospective
Last update:2018-01-24, 1396/11/04
Update count:0
Registration date
2018-01-24, 1396/11/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3355 5670
Email address
l.sabzmakan@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
2016-11-20, 1395/08/30
Actual recruitment end date
2017-02-18, 1395/11/30
Trial completion date
empty
Scientific title
The effect of educational intervention based on PRECEDE model on Increasing physical activity among women with polycystic ovarian syndrome
Public title
Increasing physical activity among women with polycystic ovarian syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
women with polycystic ovarian syndrome
age 18-40
Declaration of written and oral consent for participation in the study
Reading and writing at least elementary
Lack of disability and motor limitation
Not having a known mental disorder
Patients under the supervision of the physician should have physical activity, such as cardiovascular disease, advanced diabetes
Exclusion criteria:
Pregnancy and lactation
Taking hormonal medications
Use of infertility treatment methods
smokers
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
random allocation- permoted block randomization- stratified (age)-
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
Ethics committee of Alborz University of Medical Sciences
Street address
45 metri golshahr- saffarian street- school of health-
City
karaj
Province
Alborz
Postal code
3183744439
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
Abzums.Rec.1395.23
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E35.8
ICD-10 code description
Disorders of other endocrine glands in diseases classified elsewhere
Primary outcomes
1
Description
physical activity- steps- weight- BMI
Timepoint
Three months
Method of measurement
IPAC questionnaire- pedometer- scale- meter
Secondary outcomes
1
Description
knowledge- attitude- self efficacy- skill- social support
Timepoint
three months
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group:
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh hospital
Full name of responsible person
leila sabzmakan
Street address
45 metri golshahr- saffarian street- school of health
City
Karaj
Province
Alborz
Postal code
3183744439
Phone
+98 26 3355 5670
Email
sabzmakan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad norisepehr
Street address
45 metri golshahr- saffarian street- school of health
City
Alborz
Province
Alborz
Postal code
3183744439
Phone
+98 26 3355 5670
Email
sabzmakan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
25
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
Karaj University of Medical Sciences
Full name of responsible person
leila sabzmakan
Position
Assisstance professor- Alborz university of medical scinces
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
45 metri golshahr- saffarian street- school of health
City
Karaj
Province
Alborz
Postal code
3183744439
Phone
+98 26 3355 5670
Email
sabzmakan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Lelia sabzmakan
Position
Assisstance professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
45 metri golshahr- saffarian street- scool of health
City
Karaj
Province
Alborz
Postal code
3183744439
Phone
+98 26 3355 5670
Email
sabzmakan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
leila sabzmakan
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
shahid saffarian
City
karaj
Province
Alborz
Postal code
3183744439
Phone
+98 26 3464 3922
Email
sabzmakan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available