Protocol summary

Summary
at first a cross-sectional study was done. The sample consisted of425، 18-15 year-old female student that are studying at The secondary public schools in 2016, selected by stage randomly sampling. After determining the initial sample size,students height and weight will be measured .also The questionnaire containing demographic information, self-efficacy of eating habits and physical activity, and health literacy NVS (Newest vital signe ) , for them is completed. Before the study ,the localization and adaptation of self-efficacy of eating habits and self efficacy of regular physical activity questionnaires with cultural and social characteristics of the community, will be done. After the first stage students who have low levels of health literacy, self-efficacy of eating habits and physical activity behavior and eligible to enter the intervention stage and with no problem and a specific disease, and have a desire to participate in the study, divided into two experimental and control groups. The number of samples in each group in education and intervention phase, on the basis of Ezzati Article at least 40 people were calculated. With regard to the possible lack of random assignment on an individual basis, randomized intervention and control groups at the school level is done. School,taking into consideration social, economical and cultural Conditions assigned to two experimental and control groups. Training methods to groups with role-plays, practical work and lectures are given and before training, immediately after training and three months later followed up and compared to the control group

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016101628863N6
Registration date: 2017-07-10, 1396/04/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-10, 1396/04/19
Registrant information
Name
Nooshin Peyman
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 502 6195
Email address
peymann@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-12-04, 1395/09/14
Expected recruitment end date
2017-01-30, 1395/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on the theory of self-efficacy on health literacy, self efficacy of eating habits and physical activity in the second secondary school students
Public title
The effect of education based on the theory of self-efficacy on health literacy,self efficacy of eating habits and physical activity in the second secondary school students
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1. The second secondary school students who have completed consent and are willing to cooperate 2. The second secondary school students who do not have physical health problems 3. The second secondary school students that do not have a particular disease, disability and mental health problems 4. Having Iranian nationals Exclusion criteria: 1-absence over a meeting attended training courses 2. Do not complete the post-test questionnaire 3-occurrence of certain events during the study in student that lead to diseases that affect the study
Age
From 15 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 425
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

1

Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty

2

Registry name
no
Secondary trial Id
no
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences School of Health
Street address
School of Health, Mashhad University of Medical Science, Mashhad, Iran
City
mashhad
Postal code
Approval date
2017-03-15, 1395/12/25
Ethics committee reference number
IR.MUMS.REC.1395.623

Health conditions studied

1

Description of health condition studied
health literacy,Self-Efficacy to Regulate Eating Habits and Self-Efficacy to Regulate Exercise
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
health literacy
Timepoint
Before the intervention, immediately after the intervention and three months after intervention
Method of measurement
Complete the questionnaire

2

Description
Self-Efficacy to Regulate eating habits
Timepoint
Before the intervention, immediately after the intervention and three months after intervention
Method of measurement
Complete the questionnaire

3

Description
Self-Efficacy to Regulate Exercise
Timepoint
Before the intervention, immediately after the intervention and three months after intervention
Method of measurement
Complete the questionnaire

Secondary outcomes

1

Description
Weight
Timepoint
Before the intervention, immediately after the intervention and three months after intervention
Method of measurement
Digital scales Seca

2

Description
Height
Timepoint
Before the intervention, immediately after the intervention and three months after intervention
Method of measurement
Tape measure

3

Description
Body Mass Index
Timepoint
Before the intervention, immediately after the intervention and three months after intervention
Method of measurement
Weight divided by height squared

4

Description
Regular physical activity per week
Timepoint
Before the intervention, immediately after the intervention and three months after intervention
Method of measurement
Self-report questionnaire

5

Description
Watching TV, using computers and mobile phones during the day
Timepoint
Before the intervention, immediately after the intervention and three months after intervention
Method of measurement
Self-report questionnaire

Intervention groups

1

Description
In the intervention group, six 45-minute sessions based on the theory of self-efficacy will be conducted
Category
Lifestyle

2

Description
In control group we do not give them the instructions in intervention group. But in this group training is given with different topics of the experimental group educational topics.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences School of Health
Full name of responsible person
nooshin peyman
Street address
School of Health, Mashhad University of Medical Science, Mashhad, Iran
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
nooshin peyman
Street address
School of Health, Mashhad University of Medical Science, 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
School of Health, Mashhad University of Medical Science
Full name of responsible person
Nooshin Peyman
Position
Associate Professor Management & Social Determinants of Health Research Center, Department of He
Other areas of specialty/work
Street address
Management & Social Determinants of Health Research Center School of Health, Mashhad University of Medical Science, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51
Fax
Email
peymann@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Health, Mashhad University of Medical Science
Full name of responsible person
nooshin peyman
Position
Associate Professor
Other areas of specialty/work
Street address
School of Health, Mashhad University of Medical Science
City
Mashhad
Postal code
Phone
+98 51 3854 4643
Fax
Email
peymann@mums.ac.ir
Web page address

Person responsible for updating data

Contact

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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