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The effect of education based on extended parallel process model on weight and knowledge of women about overweight before pregnancy

Protocol summary

Summary
The purpose of this study is evaluating the effect of education based on extended parallel process model on weight and knowledge of women about overweight before pregnancy. Sample size is sixty women with BMI more than Twenty-five, referred to counseling pre-pregnancy to health centers in Mashhad. For Sampling, at first one center selected from the five main health centers and then two sub-centers selected by tables of random numbers, one center as intervention and other as control group. The intervention group received two sessions of group training (by Interval is two days) based on concepts of extended parallel process model. At the beginning of the study, individuals in both groups received a nutritional check list based on the instructions in the Ministry of Health's maternal and child nutrition booklet. They would have to complete it at home and were delivered to researcher two and four weeks after intervention. instruments for collecting Data were questionnaires included: demographic, knowledge, concepts of model including susceptibility, severity, self-efficacy and perceived response, anxiety, physical activity, body image, eating disorders, Social protection questionnaires, as well as meters and scales for measuring body mass index. Before, two and four weeks after the intervention, instruments used.

General information

Acronym
Extended parallel process model: EPPM
IRCT registration information
IRCT registration number: IRCT2015122325668N1
Registration date: 2016-12-15, 1395/09/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-15, 1395/09/25
Registrant information
Name
Seyede Zahra Mostajabi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
mostajabiz921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on extended parallel process model on weight and knowledge of women about overweight before pregnancy
Public title
Effect of theory-based training on weight and knowledge of women about overweight before pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women aged 18 to 49 years, consent to participate in the study, body mass index over than 25 and less than 40. Exclusion criteria: age under 18, not wanting to attend, absent in training sessions or complete checklist incompletely, chronic disease
Age
From 18 years old to 49 years old
Gender
Female
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done by Tables of random numbers

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Flat 2 , Qoreishi Bldg. Daneshgah St. Mashhad, Iran
City
Mashhad
Postal code
vcresearch[at]mums.a
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.mums.REC.1394.543

Health conditions studied

1

Description of health condition studied
overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
knowledge
Timepoint
before training, after 2 weeks, 4 weeks after training
Method of measurement
Assessment by a questionnaire designed by researcher

2

Description
weight
Timepoint
before training, after 2 weeks, 4 weeks after training
Method of measurement
By weight scale

Secondary outcomes

1

Description
enxiety
Timepoint
before training, after 2 weeks, 4 weeks after training
Method of measurement
Spielberger Anxiety Inventory

2

Description
physical activity
Timepoint
before training, after 2 weeks, 4 weeks after training
Method of measurement
Baec phisical activity questionnaire

3

Description
Concepts of modell (sensitivity and Severity Perceived, Response Efficacy Perceived, Self Efficacy Perceived)
Timepoint
before training, after 2 weeks, 4 weeks after training
Method of measurement
Assessment by a questionnaire designed by researcher

4

Description
Social protection
Timepoint
before training
Method of measurement
Perceived Social Support – Family Scale (PSSFa)

5

Description
Eating disorders
Timepoint
before training
Method of measurement
Eating Disorder Examination Questionnaire (EDE-Q)

6

Description
Body image
Timepoint
before training
Method of measurement
Body figure rating scale questionnaire

Intervention groups

1

Description
In addition to standard care in health centers and use a check List for nutrition, two training sessions based on Extended Parallel Process Model
Category
Lifestyle

2

Description
In addition to standard care in health centers, use a check List for nutrition
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Siloo health center in mashhad city
Full name of responsible person
Street address
City
Mashhad

2

Recruitment center
Name of recruitment center
Sahrayi health center in mashhad city
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr.mahyar mirheidari
Street address
Flat2 , Qoreishi Bldg. Daneshgah St. Mashhad, Iran
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyede Zahra Mostajabi
Position
Master student of midwifery counseling
Other areas of specialty/work
Street address
Unit 1, Ghaem guesthouse, in front of Ghaem Hospitall, Ahmadabad St.Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3841 1538
Fax
Email
mostajabiz921@mums.ac.ir; mama1387@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyede Zahra Mostajabi
Position
Master student of midwifery counseling
Other areas of specialty/work
Street address
Unit 1, Ghaem guesthouse, in front of Ghaem Hospitall, Ahmadabad St.Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3841 1538
Fax
Email
mostajabiz921@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyede Zahra Mostajabi
Position
Master student of midwifery counseling
Other areas of specialty/work
Street address
Unit 1, Ghaem guesthouse, in front of Ghaem Hospitall, Ahmadabad St.Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 935 598 2856
Fax
Email
mostajabiz921@mums.ac.ir
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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