Protocol summary

Summary
This is a quasi-experimental study. The purpose of this study is evaluation of the effectiveness of health education based on BASNEF model on nutritional and weight- control behaviors in middle age women covered by health centers in the south of Tehran. Inclusion criteria: Aged between 30-59. No participation in the same educational classes. Wishing to participate in the study. Exclusion criteria: having missed a single session of training sessions. Unwillingness to continue the study. During the implementation of the study, women participate in another research with the same subject. The sample were All women aged 30 – 59 were covered by health centers in south of Tehran. A total of 100 clients who were eligible for the study and were randomly divided into two groups (control and experimental (.intervention program consisted of four sessions of 60 minutes in this study. Primary outcomes were Awareness, Attitude, Subjective Norms, Enabling Factors and Intent to Act. Data will be collected using self-reported questionnaire before and 4 weeks after education.

General information

Acronym
does not.
IRCT registration information
IRCT registration number: IRCT2016042427566N1
Registration date: 2016-06-26, 1395/04/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-26, 1395/04/06
Registrant information
Name
Fatemeh Khodajoo
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
f_khodajoo@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science - Vice-Chancellor for Research.
Expected recruitment start date
2016-05-10, 1395/02/21
Expected recruitment end date
2016-06-14, 1395/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational based on BASNEF model on nutrition and weight control of middle- age women.
Public title
Effect of education on nutrition and weight control.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: being able to speak in Persian; Aged between 30-59; No participation in the same research or educational classes; Being able to read and write; Availability of telephone to follow up in experimental group and make a contact to do post- test in control group. Wishing to participate in the study. Exclusion criteria: having missed a single session of training sessions; Unwillingness to continue the study; Disease resulted in hospitalization. During the implementation of the study; women participate in another research with the same subject.
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Ethical Review Commitee of Tehran University of Medical Sciences
Street address
6th floor, Central building of Tehran University of Medical Sciences,Ghods St., Keshavarz Blvd. Tehran
City
Tehran
Postal code
Approval date
2016-03-01, 1394/12/11
Ethics committee reference number
IR.TUMS.REC.1394.2109

Health conditions studied

1

Description of health condition studied
nutritional behaviors and weight control
ICD-10 code
Z71.3, Z72
ICD-10 code description
obesity, inappropriate diet or eating habits

Primary outcomes

1

Description
Nutritional behaviors
Timepoint
Preintervention and 4 weeks later
Method of measurement
Component model questionnaire

2

Description
Weight- control behaviors
Timepoint
Preintervention and 4 weeks later
Method of measurement
Component model questionnaire

Secondary outcomes

1

Description
life style (nutritional and weight control)
Timepoint
Preintervention and 4 weeks late
Method of measurement
Component model questionnaire

Intervention groups

1

Description
Pre – test was used in experimental group at baseline. Experimental group gave lifestyle education program in both nutritional and weight-control behavior. Healthy lifestyle education intervention program in this study consisted of four session of 60 minutes. Giving a lecture and questioning – answering and discussion method were used to educate the middle age women. Experimental group was educated about the importance of healthy lifestyle and the role of it in preventing disease and health promotion. Sessions include: two session “the basics of healthy nutrition in the middle age women, with an emphasis on BASNEF model components”. One session “weight-control ”. One session “conclusion”. Intervention took two week in general.
Category
Lifestyle

2

Description
In the control group,adolescents in the initiation of intervention and 4 weeks after intervention fill out the questionnaire. Control group don't receive any intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
South Tehran Health Centers
Full name of responsible person
Fatemehkhodajoo
Street address
Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
6th floor, Tehran University of medical sciences, Ghods Ave., Keshavarz Blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical 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
Faculty of Nursing and Midwifery (Tehran University of Medical Science)
Full name of responsible person
Fatemehkhodajoo
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Number 1, Eastern Nosrat St, Tohid Squier, Tehran
City
Tehran
Postal code
Phone
+98 917 891 5450
Fax
Email
Fatemehkhodajoo@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Hayedeh Noktehdan
Position
Trainer, Faculty
Other areas of specialty/work
Street address
Number1, Eastern Nosrat St, Tohid Squeir, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
noktehdan_h@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Fatemehkhodajoo@yahoo.com
Position
Master Student of Nursing
Other areas of specialty/work
Street address
Number1, Eastern Nosrat St, Tohid Squeir, Tehran
City
Tehran
Postal code
Phone
Fax
Email
Fatemehkhodajoo@yahoo.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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