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The effect of educational package of family-centered behavioral modification on the child and family Dietary habits and BMI percentile of school-age obese girls

Protocol summary

Study aim
The effect of educational package of family-centered behavioral modification on the child and family Dietary habits and Body Mass Index(BMI) percentile of school-age obese girls
Design
Clinical trial with control group, with parallel groups, randomized
Settings and conduct
80 obese girls aged 7-12 years old with a BMI percentile of more than 85 will be selected from the 4 schools, which will be the research environment, by the available method. In the intervention group, Researcher-made training package “family-oriented behavioral reform” will be taught in 7 sessions of 45 minutes, then the BMI percentile, child and family behavior and eating habits and anthropometric indicators will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with a BMI percentile greater than 85%(WHO definition of childhood overweight and obesity), Age between 7- 12 years, Mother's attendance at the training sessions, Parent's ability to read and write, Informed consent to participate in the study, Living with both parents. Exclusion criteria: Participating in another weight control program, Having psychiatric disorder, heart disease or shortness of breath during exercise, Medical status or use of medications for weight loss, Reaching puberty
Intervention groups
In the intervention group, the child and mother will be taught the family- centered behavioral modification educational package, and at the end, they will be given the educational package, and the follow-up will continue for 3 months by weekly telephone call. In the control group, information about obesity and its complications will be given and at the end of the research, they will be given an educational package.
Main outcome variables
Child and family eating behaviors and habits , BMI percentile

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191203045584N1
Registration date: 2020-08-29, 1399/06/08
Registration timing: prospective

Last update: 2020-08-29, 1399/06/08
Update count: 0
Registration date
2020-08-29, 1399/06/08
Registrant information
Name
Hadiseh Asadabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 8511
Email address
asadabadih961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational package of family-centered behavioral modification on the child and family Dietary habits and BMI percentile of school-age obese girls
Public title
Effect of Family-centered behavioral Modification training on Dietary habits and BMI of obese children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Children with a BMI percentile greater than 85%(WHO definition of childhood overweight and obesity) Age between 7- 12 years Mother's attendance at the training sessions Parent's ability to read and write Informed consent to participate in the study Living with both parents
Exclusion criteria:
participating in another weight control program Having a psychiatric disorder Exercise heart disease or shortness of breath during exercise Medical status or use of medications for weight loss Reaching puberty
Age
From 7 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The research population will be selected by simple randomization method without alternatives using envelopes, so that out of ten schools in one of the middle areas of Mashhad city, 2 schools will be selected as the intervention group and 2 schools as the control group. It is necessary to explain that the first and third choices will be the intervention group and the second and fourth choices will be the control group.Randomization on samples is not possible due to their inclusion in the study with special features. 80 obese girls aged 7-12 years old with a BMI percentile of more than 85 will be selected from the above 4 schools, which will be the research environment, by the available method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad Nursing And Midwifery Schole, Ebne Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.075

Health conditions studied

1

Description of health condition studied
Dietary counselling and surveillance
ICD-10 code
Z71.3
ICD-10 code description
Dietary counseling and surveillance

Primary outcomes

1

Description
The rate of change in child and family eating behavior and habits
Timepoint
The first training session and at the end of the third month
Method of measurement
Child Eating Behavior Questionnaire and Duch Eating Behavior Questionnaire and Child and Family Dietary Habits Questionnaire

2

Description
BMI percentile percentage
Timepoint
First meeting and at the end of each month for 3 months
Method of measurement
Meters and scales

3

Description
Skin thickness
Timepoint
Before the intervention and at the end of the intervention
Method of measurement
Caliper

4

Description
Arm circumference
Timepoint
Before the intervention and at the end of the intervention
Method of measurement
Non-stretch calibrated tape

5

Description
Height
Timepoint
First meeting and at the end of each month for 3 months
Method of measurement
Meter

6

Description
Weight
Timepoint
First meeting and at the end of each month for 3 months
Method of measurement
Scales

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Family-centered behavioral modification educational package (contains information on obesity, motivation and skills development that is extracted from articles, book and program of Iran Eco and approved by the professors of Mashhad School of Nursing and Midwifery and nutritionist) in 7 sessions of 45 minutes will be taught for child and mother (mother presence is required in half of the sessions), at the end of the educational sessions, the educational package will be given to them and the follow-up will continue for 3 months by weekly phone call.
Category
N/A

2

Description
Control group: information about obesity and its complications will be given and at the end of the research, they will be given an educational package.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected Primary Schools of Nursing Education in Mashhad City
Full name of responsible person
Dr. Tahereh Sadeghi
Street address
Ayatollah Behjat St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3225 5723
Email
Sadeghit@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Robabeh Latifnezhad
Street address
Ebne- Sina Street,School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3852 8511
Fax
+98 51 3852 8511
Email
Sadeghit@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Tahereh Sadeghi
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 56 3254 1036
Email
Sadeghit@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Tahereh Sadeghi
Position
Academic Staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne sina st
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 56 3254 1036
Email
Sadeghit@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hadiseh Asadabadi
Position
Master of Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
mashhad nursing and midwifery schole, ebne sina st
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 56 3254 1036
Email
asadabadih961@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
For researchers working only in academic and scientific institutions
Under which criteria data/document could be used
School Health
From where data/document is obtainable
Mashhad School of Nursing and Midwifery
What processes are involved for a request to access data/document
Immediately by visiting the library of Mashhad School of Nursing and Midwifery
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