Protocol summary

Study aim
Determining and comparing the effects of a social media intervention on the average volume of water consumption in the students of the intervention group compared to the control group before, immediately and three months after the intervention
Design
A before and after field trial with a comparison group, randomized, blinded on 388 participants.
Settings and conduct
Setting: Girls' Secondary schools in Yasuj, Kohgiloyeh and Boyerahmad province Method: The intervention is done virtually using a social media Blinding: Both intervention and comparison groups receive training through a social media, but participants are unaware of the content and structure of the tailored education (based on a selective framework) or general. In other words, they do not know which group they belong to
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Residence in Yasuj f Lack of diet and history of regular medication No cardiovascular, renal, hepatic diseases, diabetes, and hypertension Exclusion criteria No tendency to participation in the study
Intervention groups
Intervention group: Grade 7 to 9 Female Students of Yasuj in the school selected as the intervention group. Students in the experimental group receive a social media intervention to improve water consumption by the STARS in each class. Comparison group: Grade 7 to 9 Female Students of Yasuj in the school selected as the Comparison group. Students in the Comparison group will receive some general information about water consumption through the researcher.
Main outcome variables
Volume of water consumed daily by students Habit of drinking water during the day

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201229049874N1
Registration date: 2021-09-23, 1400/07/01
Registration timing: prospective

Last update: 2021-09-23, 1400/07/01
Update count: 0
Registration date
2021-09-23, 1400/07/01
Registrant information
Name
Sedigheh Shariatinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
shariati@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and Assessing Effects of a Social Media Intervention for Improve Water Drinking Behaviour Among Grade 7 to 9 Female Students of Yasuj, Iran
Public title
Social Media Intervention for Improve Water Drinking Behaviour among students in Yasuj, Iran
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Residence in Yasuj Lack of diet and history of regular medication No cardiovascular, renal, hepatic diseases, diabetes, and hypertension
Exclusion criteria:
No tendency to participation in the study
Age
From 13 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 388
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a field trial (Before and after study with a randomized comparison group) with 194 people in each group (water intervention and comparison group). Using simple randomization method, two school will be selected out from the list of secondary schools in Yasuj, where the number of seventh to ninth grade students is calculated equal to the sample size. Out of two schools, one is randomly assigned to experimental group and the other to the comparison group. All seventh to ninth grade students from these two schools enter the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both intervention and comparison groups receive training through a social media, but participants are unaware of the content and structure of the tailored education (based on a selective framework) or general. In other words, they do not know which group they belong to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar-Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-12-27, 1399/10/07
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399625

Health conditions studied

1

Description of health condition studied
Water consumption
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mean Volume of daily water consumption
Timepoint
At the beginning of the study (before the intervention), during the intervention, immediately after the intervention, one month and three months after the intervention
Method of measurement
Recording the volume of daily water consumption as a self-report by Liq in 7

Secondary outcomes

1

Description
Habit to regular water consumption during day
Timepoint
Before the intervention, one month and three months after the intervention
Method of measurement
Self-reported by The Self-Report Habit Index

Intervention groups

1

Description
Intervention group: 7th to 9th grade female students in the secondary school of Yasuj, which has been selected as the intervention school. The selection of intervention components, behavioral change strategies, and educational methods and materials is mainly based on social cognitive theory. Students in the intervention group receive one of the interventions each week for three months through one of the social networks and online. Interventions in this group include providing the desired content through text messages, videos, audio and short text files, providing individual advice and feedback, publishing successful and unsuccessful experiences in the group, starring students who drank more water during the last week, help students to set short-term and long-term goals, verbally encourage students, encourage students to self-reward, use reminders to record the volume of water consumed, and develop a water drinking commitment letter and approval by students. The required content and media will be compiled by the researcher. Forming a group and presenting all the interventions is done by Stars in each class who has been trained to do this, and in this way the influence of peers is used to improve the drinking behavior of students. The researcher supervises the leadership of the group and the implementation of interventions by the stars, the discussions and the participation of all members of each group. Coordination and planning will be done with the school principal before the intervention.
Category
Lifestyle

2

Description
Control group: 7th to 9th grade female students in the secondary school of Yasuj, which has been selected as the control school. The comparison school will only receive a series of general and background information on the subject through the researcher, and peers will have no role in this group. Educational content will be provided to them after the end of the study.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Female secondary school of Yasuj
Full name of responsible person
Ahmad Ali Eslami
Street address
Golestan15 St., , Pasdaran Blvd.,
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875114
Phone
+98 74 3322 6850
Email
shariati@hlth.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Shaghayegh Hagh Joo Javanmard
Street address
Hezar-Jarib St.,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
shariati@hlth.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfarayen University of Medical Sciences
Proportion provided by this source
100
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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ali Eslami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezar-jarib St.,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
eslamiaa@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ali Eslami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezar-Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
eslamiaa@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ali Eslami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezar-jarib St.,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
eslamiaa@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data related to the main outputs of the study
When the data will become available and for how long
One year after the publication of the study results
To whom data/document is available
Researchers working in universities and scientific institutes
Under which criteria data/document could be used
Conducting meta analysis
From where data/document is obtainable
Refer to the site of Isfahan University of Medical Sciences Vice Chancellor for Research Call Dr. Ahmad Ali Eslami or send a request email to him
What processes are involved for a request to access data/document
Send the request email and respond to it by the responsible person
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