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Comparative effectiveness of theory-based Educational intervention program and common education on anthropometric parameters, biochemical and blood pressure in obese adolescents.

Protocol summary

Summary
This study was carried out to evaluate the effectiveness of a focused nutrition education intervention to reduce the components of metabolic syndrome by using the Health Belief Model (HBM) among obese adolescents in Iran. In this Randomized controlled trial, an educational intervention program was conducted among 90 adolescents, living in Isfahan province of Iran. The inclusion criteria were as follows: age between 12–18 years, being overweight or obese. These participants were selected among obese adolescents who were referred from healthcare centers and schools to the Childhood Obesity Research Clinic of Pediatric Preventive Cardiology Department at Isfahan Cardiovascular Research Center. Participants were randomly assigned into intervention and control groups by simple randomization based on coin toss. The intervention group (n=46) participated in 12 educational sessions (one session/week) including educational lecture, group discussion, question-answer, pamphlet, booklet, power-point slide show on physical activity and its advantages, obesity and its consequences, susceptibility of obese people to cardiovascular disease and diabetes and healthy eating key-points based on the food guide pyramid. The control group (n=44) was assigned a usual program. Anthropometric, biochemical, dietary and blood pressure measurements were collected before the intervention at baseline (T0), at 3 months after the intervention (T1) and 3 months after the end of the intervention (T2) in order to evaluate the effectiveness of the nutrition education intervention program. All persons collecting information were unaware from the placement of adolescents in the case and control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051017639N1
Registration date: 2015-07-13, 1394/04/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-13, 1394/04/22
Registrant information
Name
MOJGAN NOURIAN
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2671
Email address
nourian@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Self-funding
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-02-04, 1388/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effectiveness of theory-based Educational intervention program and common education on anthropometric parameters, biochemical and blood pressure in obese adolescents.
Public title
Nutrition education among obese adolescents
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria • Age between 12–18 years • Overweight or obese (BMI in the 85th–95th percentile or ≥95th percentile for age and sex) • Abdominal obesity (waist circumference ≥90th percentile for age and sex based on waist circumference cut-offs for Iranian children and adolescents) Exclusion criteria • History of diabetes and/or cardiovascular disease • Disease of the liver or any endocrine organ • Use of medication affecting serum lipids and serum glucose level • Following any prescribed diet and/or exercise program in the 6 months prior to the study
Age
From 12 years old to 17 years old
Gender
Both
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
After screening the eligible participants were randomly assigned to the control group or the intervention group by simple randomization. In this case, all of the 100 participants numbered from 1 to 100 and divided in two groups based on odds and even numbers. Then, by coin toss the participants with odds number were considered as intervention group and the participants with even number were considered as control group.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of UPM university in Malaysia
Street address
UPM university in Malaysia
City
Selangor
Postal code
Approval date
2008-08-20, 1387/05/30
Ethics committee reference number
(UPM/FPSK/PADS/T7-MJKEticaPer/F01

Health conditions studied

1

Description of health condition studied
Obesity in adolescents
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Dietary intake-physical activity
Timepoint
Before the intervention, at 3 months after the intervention and 3 months after the end of the intervention
Method of measurement
Food record Questionnaire

Secondary outcomes

1

Description
Biochemical measurements, Blood Pressure, waist circumference
Timepoint
Before of the intervention, at 3 months after the intervention and 3 months after the end of the intervention
Method of measurement
Enzymatic method, kit (Parsazmoon), immunoturbidimetric method using Rondex commercially kit, Sphygmomanometer-Tape

Intervention groups

1

Description
Intervention1: Educational intervention based on education model (HBM) The intervention group (n=46) participated in 12 educational sessions (one session/week) including educational lecture, group discussion, question-answer, pamphlet, booklet, power-point slide show on physical activity and its advantages, obesity and its consequences, susceptibility of obese people to cardiovascular disease and diabetes and healthy eating key-points based on the food guide pyramid.
Category
Behavior

2

Description
Intervention 2: The control group was assigned a usual program which included simple recommendations to reduce the intake of energy-dense foods such as fried foods, fast foods, cream, sugar and soft drinks in their diet and increasing the consumption of vegetables and fruits and doing more physical activity.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center in Isfahan university of medical science
Full name of responsible person
Street address
Hezar Jerib Avenue, Isfahan University of Medical Sciences
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Science
Full name of responsible person
Roya Kelishadi
Street address
Building No. 4, Hezar Jerib Avenue, Isfahan University of Medical Science, Isfahan
City
Isfahan
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, Isfahan University of Medical Science
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
Isfahan University of Medical Science/Nutrition Department
Full name of responsible person
Mojgan Nourian
Position
Ph.D / Lecturer
Other areas of specialty/work
Street address
Nutrition Department, Hezar Jerib Avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2671
Fax
Email
nourian@hlth.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Mojgan Nourian
Position
PhD/lecture
Other areas of specialty/work
Street address
Nutrition Department, Hezar Jerib Avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2671
Fax
Email
nourian@hlth.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Nutrition and Food Sciences
Full name of responsible person
Mojgan Nourian
Position
Ph.D/ Lecture
Other areas of specialty/work
Street address
Nutrition Department, Hezar Jerib Avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2671
Fax
Email
nourian@hlth.mui.ac.ir
Web page address

Sharing plan

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