Protocol summary

Summary
Aim: This study aimed to examine the effects of face to face education and use of mobile short messages-Based Intervention on the body mass index and nutritional habits on overweight and obese female students. Method and materials: this is a single blind randomized clinical trial that conducted in Qazvin University of Medical Sciences. The sample were overweight and obese Females students that selected by convenience sampling. Samples were assigned randomly in two groups each group were 25 numbers. Randomization performed by a separate draw for each person by using green balls and blue balls. Inclusion criteria: being overweight (BMI ≥ 25) and obese (BMI ≥ 30) female students, have mobile. Exclusion criteria: not being pregnant or breastfeeding, not taking medications known to cause weight gain. Baseline BMI and nutritional habits were measured in two groups by using stadiometer, and nutritional habits questionnaire. Subjects in group one attended a face to face education session and received recommendations for weight control and nutritional habits, and subjects in group two received short messages about the nutritional habits and weight control twice a day for two months. After one month body mass index and nutritional habits were measured in two groups.This was a single blind study, so the subjects didn’t know they were in which group are there allocated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201601231407N7
Registration date: 2016-05-14, 1395/02/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-14, 1395/02/25
Registrant information
Name
Jalil Azimian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 7267
Email address
jazzimian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and technology. Qazvin University of Medical Sciences. Qazvin. Islamic Republic Of Iran.
Expected recruitment start date
2015-06-21, 1394/03/31
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
َ A clinical trial on comparing the effect of face to face education and training with short messages on the body mass index and nutritional habits in the overweight and obese female students of Qazvin University of Medical Sciences.
Public title
Assessing the effect of face to face education and training with short messages on the body mass index and nutritional habits of students.
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: Being overweight (BMI ≥ 25) or obese (BMI ≥ 30), have their own mobile phone. Exclusion criteria: Not being pregnant or breastfeeding. Not taking medications known to cause weight gain.
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
with two intervention groups

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Vice chancellor for Research and technology. Qazvin University of Medical Sciences. Qazvin. Islamic Republic Of Iran
City
Qazvin
Postal code
59811-34197
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
ir.Qums.rec.1394.226

Health conditions studied

1

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

Primary outcomes

1

Description
body mass index
Timepoint
Before and three months after the study
Method of measurement
Subjects body weights were obtained with a digital adult calibrated scale (model 708,Seca , Germany, 0.01 kg) and their Heights were obtained by wall-mounted stadiometer(model 206,Seca , 0.1 cm), respectively. Body mass index (BMI; in kg/m2) was calculated.

Secondary outcomes

1

Description
nutritional habits.
Timepoint
Before and three months after the study.
Method of measurement
nutritional habits questionnaire.

Intervention groups

1

Description
Intervention group (1): Attending a face to face educational session for weight control and Nutritional habits.
Category
Lifestyle

2

Description
Intervention group (2): Receiving two interactive messages daily about weight control and Modification of nutritional habits for two months.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Fatemeh Mohammadi
Street address
Nursing and midwifery school, Qazvin University of Medical Sciences, Bahonar ”Blvd.”, Qazvin, Iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research and Technology of Qazvin University of Medical Sciences. Qazvin. Iran
Full name of responsible person
Taghi Naserpur Farivar
Street address
vice chancellor for Research and Technology, Qazvin University of Medical Sciences, Bahonar ”Blvd.”, Qazvin, Iran
City
Qazvin.
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 and Technology of Qazvin University of Medical Sciences. Qazvin. Iran
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
Nursing and Midwifery school, Qazvin University of Medical Sciences, Qazvin, Iran
Full name of responsible person
Jalil Azimian
Position
PhD in Nursing, assistant professor
Other areas of specialty/work
Street address
Nursing and Midwifery school, Qazvin University of Medical Sciences, Bahonar ”Blvd.”,Qazvin, Iran
City
Qazvin.
Postal code
3414638588
Phone
+98 28 3336 0001
Fax
+98 283337268
Email
azzimianj@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences.
Full name of responsible person
Jalil Azimian
Position
PhD in Nursing, assistant professor
Other areas of specialty/work
Street address
Nursing and Midwifery school, Qazvin University of Medical Sciences, Bahonar ”Blvd.”, Qazvin, Iran
City
Qazvin.
Postal code
59811-34197
Phone
+98 26 3336 0002
Fax
+98 33 37268
Email
azzimianj@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and midwifery school, Qazvin University of Medical Sciences
Full name of responsible person
Jalil Azimian
Position
PhD in Nursing, assistant professor
Other areas of specialty/work
Street address
Nursing and midwifery faculty, Qazvin University of Medical Sciences, Bahonar ”Blvd.”, Qazvin, Iran
City
Qazvin.
Postal code
59811-34197
Phone
+98 28 3336 0002
Fax
+98 283337268
Email
azzimianj@yahoo.com
Web page address
Info@qums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
empty
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