This study aimed to design and evaluation based intervention aimed at enabling mothers to prevent obesity in 6-4 years old children will be conducted in kindergartens in Behbahan city. This study is a randomized trial. Before random assignment to intervention and control groups, mothers of children complate the questionnaires (pre -test). After division, the intervention group (mothers) will receive educational intervention. Educational intervention based on social cognitive theory and the theory of family system (skills and parenting practices). control group will not receive any intervention. (Control group after completion of the study, held training sessions on healthy life style.) mothers (intervention and control groups), 3 and 6 months post-intervention respond to questionnaires again . (after the test). Then the data is analyzed and the results will be extracted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012626078N2
Registration date:2016-02-12, 1394/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-12, 1394/11/23
Registrant information
Name
Elham Nejadsadeghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 46 1293 3210
Email address
nejadsadeghi_e@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Education of Tehran University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and evaluation of intervention based on enabling mothers for prevention of obesity in 4 to 6 years old children
Public title
Prevention of obesity in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Lack of consent to participate in the study; Mother with at least one child 4-6 years old.
Exclusion criteria:Unwillingness to continue to participate in the study; Pregnant women; Mothers of child out age 6-4 years old; Children who are 6-4 years old but suffered a physical disability that are activities Physical moderate to severe disorder imported;A child with a weight-related medical problem; Child who has participated in other weight management programs.
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, 16 Azar Street
City
Tehran
Postal code
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
IR.TUMS.REC.1394.1557
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Preventive behaviors of obesity in children (daily: 2 hours of physical activity, eating five portions of fruit and vegetables, eating sugar-free drinks and watching less than two hours of TV)
Timepoint
Before the intervention, 3 and 6 months after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Child eating behavior (response to the food, the answer to satiety , low dining emotional, emotional overeating, an interest in wine, enjoy a meal, eat slowly and excuses food)
Timepoint
Before, 3 and 6 months after the intervention.
Method of measurement
Questionnaire
2
Description
Skills ( communication skills , monitoring, problem solving, encourage good behavior, bad behavior management)
Timepoint
Before, 3 and 6 months after the intervention.
Method of measurement
Questionnaire
3
Description
H ow to feed the baby by the mother (the child's freedom of action, the regulation of emotions Children with food, encourage children to respect the balance and diversity in eating, control of food available to children, using food as a reward, the participation of children in meal planning, food consumption modeling, monitoring snack, Forced to eat, with the aim of limiting the child's health, weight control and nutrition training with the aim of limiting the child-to-child)
Timepoint
Before, 3 and 6 months after the intervention.
Method of measurement
Questionnaire
4
Description
Constructs of social cognitive theory (environmental factors, expected outcomes, emotional adjustment, self-control and self-efficacy)
(Weight in kilograms) divided by (height in meters squared 2)
Intervention groups
1
Description
The intervention group (mothers), educational intervention (training classes) will be received. Educational intervention will be based on social cognitive theory and the theory of family systems (parenting skills and practices). Content, methods and number of training sessions will be according to the analysis of the results of pre - test.
Category
Prevention
2
Description
Control group will not receive any intervention . (For control group after completion of study, training sessions are held based on a healthy lifestyle)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kindergarten dependent on the well-being organization of Behbahan city
Full name of responsible person
Mohammad Rezaei Asl
Street address
Well-being organization of Behbahan city, next to the park Sharifnia, Shahid Nikpour avenue, Edalat Blvd.
City
Behbahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Education of Tehran University of Medical Sciences
Full name of responsible person
Doctor Mohammad Jalili
Street address
Tehran University of Medical Sciences, 16 Azar Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Education of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Elham Nejadsadeghi
Position
PhD student health education and health promotion
Other areas of specialty/work
Street address
School of Public Health, Poursina Street, Tehran University of Medical Sciences
City
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Fax
Email
nejadsadeghi_e@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Nejadsadeghi
Position
PhD student health education and health promotion
Other areas of specialty/work
Street address
School of Public Health, Street Poursina, Tehran university of medical science
City
Tehran
Postal code
141556466
Phone
+98 21 4293 3210
Fax
Email
nejadsadeghi_e@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Nejadsadeghi
Position
PhD student health education and health promotion
Other areas of specialty/work
Street address
School of Public Health,t Poursina Stree, Tehran University of Medical Sciences
City
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Fax
Email
nejadsadeghi_e@ razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)