Protocol summary

Summary
The purpose of this study was to investigate the effects of a participatory training program on overweight control and obesity in female adolescents. Design: The study was conducted on high school girl students with overweight and obesity. Four schools were selected randomly among a list of all the schools. Two out of the four schools were selected randomly as control and the two others as intervention groups. Setting and conduct: The sample size for each group was determined in a pilot study equal to 47 people. Participants: Height and weight for all students were measured and BMI was calculated and overweight or obese individuals were selected for the study. Inclusion criteria included: Female students with overweight and obesity. Exclusion criteria included: Absence more than one session in educational sessions. Interventions: Training program for intervention group was designed by the researcher on proper nutritional behaviors, balanced physical activity and nutritional counseling. The program was reinforced by educational aid tools and lecture and group discussion procedures. This program was performed in weekly one-hour session for six weeks. Expected outcomes were modifying anthropometric characteristics in female.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016070228747N1
Registration date: 2017-01-02, 1395/10/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Marjan Mirzania
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
mirzania.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a Participatory Training Program on the Control of Overweight and Obesity in Female Adolescents.
Public title
Effects of a Training Program on the Control of Overweight and Obesity.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Being girl; 12 to 14 years old; Being obese or overweight based on WHO references; Willing to participate by the side of each participant and her family; Without any disability. Exclusion criteria: Absence in more than one session of education.
Age
From 12 years old to 14 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
After screening the eligible (with inclusion criteria) participants were randomly assigned to the control and the intervention group. For this purpose four schools were selected randomly among of all the schools and then randomly two in control group and the two others in intervention group.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad university of medical sciences
Street address
Gonabad university of medical sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
9691793718
Approval date
2014-10-15, 1393/07/23
Ethics committee reference number
47/93

Health conditions studied

1

Description of health condition studied
Obesity and Overweight
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS

Primary outcomes

1

Description
Overewight
Timepoint
Immediately before intervention and two month after intervention
Method of measurement
Weight was measured (with participant in socks with no shoes and wearing a light gown) to the nearest 0.5 kg using a medical weight scale, zeroed and calibrated before each weight. A stadiometer calibrated in 0.5 cm intervals, was used to measure the height in bare foot, while the feet sticking together and the knees, hip, shoulder, and back were aligned with a vertical line. Their BMI was also calculated (weight in kilograms divided by the square of the height in meters).

Secondary outcomes

1

Description
Obesity
Timepoint
Immediately before intervention and two month after intervention
Method of measurement
Weight was measured (with participant in socks with no shoes and wearing a light gown) to the nearest 0.5 kg using a medical weight scale, zeroed and calibrated before each weight. A stadiometer calibrated in 0.5 cm intervals, was used to measure the height in bare foot, while the feet sticking together and the knees, hip, shoulder, and back were aligned with a vertical line. Their BMI was also calculated (weight in kilograms divided by the square of the height in meters).

Intervention groups

1

Description
Interventions group: Training program was designed by the researcher on proper nutritional behaviors, balanced physical activity and nutritional counseling. The program was reinforced by educational aid tools and lecture and group discussion procedures. This program was performed in weekly one-hour session for six weeks.
Category
Lifestyle

2

Description
Control group: In the control group no intervention was conducted.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Girls' high schools of Gonabad
Full name of responsible person
Marjan Mirzania
Street address
Gonabad university of medical sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad university of medical sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Gonabad University of Medical Sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonadad
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, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Marjan Mirzania
Position
Master of Science Student in Health Education & Promotion
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
+98 51 5722 9025
Email
m.mirzania2025@gmail.com; m.mirzania4910@gmail.com; mirzania.m@gmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Marjan Mirzania
Position
Master of Science Student in Health Education & Promotion
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
+98 51 5722 9025
Email
m.mirzania2025@gmail.com; m.mirzania4910@gmail.com; mirzania.m@gmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Marjan Mirzania
Position
Master of Science Student in Health Education & Promotion
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
+98 51 5722 9025
Email
m.mirzania2025@gmail.com; m.mirzania4910@gmail.com; mirzania.m@gmu.ac.ir
Web page address

Sharing plan

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