1. Home
  2. Approved trials
  3. » فارسی

Comparing the effectiveness of the national guideline on management of overweight and obesity with the routine services in the primary health care system on body mass index of school age children

Protocol summary

Summary
Aim of study: Determine the effectiveness of guideline for management of overweight and obesity in children through primary health care system design: not blinded controlled trial Intervention: training of health workers and then education of mothers by health workers during 2 months in 5 session to modify lifestyle Inclusion criteria: overweight or obese first grade children not using medicine affecting glucose hemoestasis not being diagnosed with hypothyroidism, diabetes, cardiovascular disease, epilepcy Not following a particular diet Exclusion criteria: having fracture during study Sample size: 89 child in each group main outcome measures: children body mass index

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013062213740N1
Registration date: 2014-04-11, 1393/01/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-11, 1393/01/22
Registrant information
Name
Nasrin Omidvar
Name of organization / entity
Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research I
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7484
Email address
n.omidvar@nnftri.ac.ir
Recruitment status
Recruitment complete
Funding source
UNICEF
Expected recruitment start date
2013-10-07, 1392/07/15
Expected recruitment end date
2014-03-06, 1392/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of the national guideline on management of overweight and obesity with the routine services in the primary health care system on body mass index of school age children
Public title
Comparing the effectiveness of the national guideline on management of overweight and obesity with the routine services in the primary health care system on body mass index of school age children
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: overweight or obese first grade children based on 2007 World Health Organization diagram؛ not using medicine affecting glucose and lipid profile hemoestasis and weight; not being diagnosed with hypothyroidism, diabetes, cardiovascular disease, epilepcy؛ not following a particular diet؛ not participate in other trials؛ exclusion criteria: having fracture during study؛ migration
Age
From 6 years old to 7 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 178
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics in research committee of National Nutrition and Food Technology Research Institute (NNFTRI) o
Street address
#7, Shahid Mahmoud Hafezi st, Shahid Farahzadi blvd.
City
Tehran
Postal code
1981619573
Approval date
2013-11-25, 1392/09/04
Ethics committee reference number
050521

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E65, E66,
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Body mass index
Timepoint
At the beginning of study, 3, 6 and 12 months after beginning
Method of measurement
kg/square meters by digital scale and walled stadiometer

Secondary outcomes

1

Description
Children calorie intake
Timepoint
At the beginning, 3, 6 and 12 months later
Method of measurement
1 day food diary

2

Description
Children physical activity
Timepoint
At the beginning of study, 3, 6 and 12 months later
Method of measurement
CASPIAN physical activity questionnaire

3

Description
Biochemical measures
Timepoint
At the beginning, 6 and 12 months after
Method of measurement
laboratory kits

4

Description
Self efficacy of mothers
Timepoint
At the beginning of study, 6 months later
Method of measurement
Questionnaire

5

Description
Providers knowledge, attitude and practice
Timepoint
At the beginning and 6 month later
Method of measurement
Questionnaire

Intervention groups

1

Description
In intervention group, educational intervention during 2 months in 5 sessions for mothers to understanding strategies for lifestyle modification
Category
Lifestyle

2

Description
In control group, routine care will be done. At the end of the study, educational booklet will be tendered to control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahra Homayoun urban health center
Full name of responsible person
Zahra Ghonche
Street address
Khaje Nasire Toosi st, before the Sepah square, Shariati st.
City
Tehran

2

Recruitment center
Name of recruitment center
Khaje Nezam urban health center
Full name of responsible person
Elham Badraghe
Street address
Sayyadi alley, Gouhari alley, at the end of Moallem st.
City
Tehran

3

Recruitment center
Name of recruitment center
Ahmadi urban health center
Full name of responsible person
Mahrokh Setavarz
Street address
At the first of Fatahnaii street, Damavand st.
City
Tehran

4

Recruitment center
Name of recruitment center
Dogmechi urban health center
Full name of responsible person
Elmira Pourmand
Street address
#96, Zarrin Ghobaii alley, Kermane Jonobi street, Resalat st.
City
Tehran

5

Recruitment center
Name of recruitment center
Samangan urban health center
Full name of responsible person
Mehrnaz Mahdipour
Street address
Shahid Baradarane Souri street, Samangan st, Narmak.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
UNICEF
Full name of responsible person
Amir Hossein Yarparvar
Street address
#7, Nezami st, Ghoba st, Shariati st.
City
Tehran
Grant name
sc109902
Grant code / Reference number
For health and nutrition work plan
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
UNICEF
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
Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research I
Full name of responsible person
Nasrin Omidvar
Position
PhD in Nutrition/Associate professor
Other areas of specialty/work
Street address
#7, Shahid Mahmoud Hafezi st, Shahid Farahzadi blvd.
City
Tehran
Postal code
1981619573
Phone
+98 21 2235 7484
Fax
Email
nomidvar@yahoo.com; omidvar.nasrin@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research I
Full name of responsible person
Nasrin Omidvar
Position
PhD in Nutrition/Associate professor
Other areas of specialty/work
Street address
#7, Shahid Mahmoud Hafezi st. Shahid Farahzadi blvd.
City
Tehran
Postal code
1981619573
Phone
+98 21 2235 7484
Fax
+98 21 2236 0660
Email
nomidvar@yahoo.com; omidvar.nasrin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research I
Full name of responsible person
Saba Narmcheshm
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
#7, Shahid Hafezi st, Shahid Farahzadi blvd.
City
Tehran
Postal code
1981619573
Phone
+98 21 2235 7484
Fax
Email
sn3689@yahoo.com
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
empty
Loading...