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The effect of educational intervention on body mass index and thyroid function tests in children and adolescents with obesity or overweight

Protocol summary

Summary
Objectives: In the present study, the effect of healthy lifestyle intervention on body mass index and thyroid function tests in children and adolescents with obesity and overweight have been investigated. Design: The current interventional research included 126 overweight or obese children and adolescents with an age range of 7 to 18, from Birjand, who were divided into two groups of 63. Assignment of samples to the two groups (control and intervention) was non random. In the intervention group, education was conducted for 6 months. TSH, FT3, FT4 and BMI in both groups were measured and compared before and after the intervention. Participants including major eligibility criteria: Entry requirements include: the children and adolescents with non-syndromic overweight and obesity, with an age range of 7 to 18 years. Withdrawal conditions including: history of radioactive iodine treatment, thyroid hormone therapy, antithyroid drugs, and children with a known type of metabolic or endocrine disorders, and lack of the parental consent. Setting, conduct and interventions: In the intervention group, education was conducted to improve lifestyle and healthy nutrition for 6 months. In the control group, intervention was not performed. Main outcome measures (primary and secondary outcome variables): Changes in BMI and TSH, FT3, and FT4 hormones were the primary and secondary consequences of the present study.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2017081935772N1
Registration date: 2017-11-12, 1396/08/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Neda Ebrahimi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3223 2895
Email address
neda.ebrahimi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Birjand University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention on body mass index and thyroid function tests in children and adolescents with obesity or overweight
Public title
The effect of educational intervention on BMI and thyroid function test
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The children and adolescents with overweight and obesity (BMI above 85% percentile); Non-syndromic children and adolescents with an age range of 7 to 18 years; The parental informed consent. Exclusion criteria: The children who had a medical history using radioactive iodine (radioiodine), thyroid hormones, and antithyroid drugs or any medication, that may affect thyroid; The children with a known type of endocrine or metabolic abnormalities; Students with lack of the parental consent.
Age
From 7 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the areas in Birjand were initially arranged based on school distribution, later, the elementary levels, middle schools, and high schools in each area were classified and divided into clusters, then, the random samples of each cluster were systematically selected from obese children and adolescents who had health records in Atherosclerosis and Coronary Artery Research Center. Assignment of samples to the two groups (control and intervention) is non-random.

Secondary Ids

1

Registry name
Birjand University of Medical Sciences
Secondary trial Id
884
Registration date
1394-02-01, 773/01/-46

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Department of pediatrics, Faculty of Medicine, Birjand University of Medical Sciences (BUMS), Ghaffari avenue
City
Birjand
Postal code
9719113944
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
Ir.BUMS.1394.298

Health conditions studied

1

Description of health condition studied
Thyroid disorders
ICD-10 code
E00, E01,
ICD-10 code description
Disorders of thyroid gland

2

Description of health condition studied
Obesity and overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Body mass Index (BMI)
Timepoint
6 months before and 6 months after of intervention
Method of measurement
Measuring of weight and height and calculate BMI according to a formula

Secondary outcomes

1

Description
Thyroid function tests
Timepoint
6 months before and 6 months after of intervention
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group: In the intervention group, the training was lectured with PowerPoint for parents, children, and adolescents in six meetings (every month, one meeting) which included the following subjects: obesity definition and its disadvantage in childhood and adulthood; the importance and benefits of weight control; recommendations and necessary actions for weight control, lifestyle modification, healthy diet, physical activity, and parental attitudes towards children. This intervention was 6 months.
Category
Lifestyle

2

Description
Control group: In the control group, educational intervention is not performed.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Dr.Neda Ebrahimi
Street address
Valiasr Hospital, Ghaffari Avenue, Birjand, Iran.
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Birjand University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Taheri
Street address
Department of Pediatrics, Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari Ave., Birjand, South khorassan, Iran
City
Birjand
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 of Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Neda Ebrahimi
Position
Student Research Committee, Resident of pediatrics
Other areas of specialty/work
Street address
Department of Pediatrics, Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari Ave., Birjand, Iran
City
Birjand
Postal code
9717853577
Phone
+98 56 3223 2895
Fax
+98 56 3243 0076
Email
neda.ebrahimi@bums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr.Neda Ebrahimi
Position
Student Research Committee, Resident of pediatrics
Other areas of specialty/work
Street address
Department of Pediatrics, Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari Ave., Birjand, Iran
City
Birjand
Postal code
9717853577
Phone
+98 56 3223 2895
Fax
Email
neda.ebrahimi@bums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Neda Ebrahimi
Position
Student Research Committee, Resident of pediatrics
Other areas of specialty/work
Street address
Department of Pediatrics, Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari Ave., Birjand, Iran
City
Birjand
Postal code
9717853577
Phone
+98 56 3223 2895
Fax
Email
neda.ebrahimi@bums.ac.ir
Web page address

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
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