Measuring the Effectiveness of Group-Based Proper Nutrition-Training Therapy on Tendency to Food Diversity and Anxiety in Preschool Children with Avoidance / Restriction Disorders
evaluation of the effectiveness of group nutrition training based on play therapy on anxiety and tendency to food diversity in preschool children with avoidance disorder / food restriction
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 10 patients. Excel software rand function was used for randomization.
Settings and conduct
The aim of this study was to evaluate the effectiveness of group nutrition training based on play therapy on anxiety and tendency to food diversity in preschool children with avoidance / restriction disorder in Sanandaj. Its design is a quasi-experimental pre-test-post-test with a control group and a follow-up stage. A blind one-way study in which the analyzer was unaware of any of the processes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having diagnostic criteria for DSM5 based on avoidance / restriction disorder; Children who do not have a clear physical illness; They are between 3 and 5 years old
Exclusion criteria: Children undergoing medical treatment and absence of more than two sessions in psychotherapy sessions.
Intervention groups
The intervention begins with 2 group training sessions for the mothers of the experimental group.
The experimental group then receives 120 minutes of intervention for 8 sessions, but the control group does not receive any intervention. At the end of the intervention, for each of the children, the two groups of eating behavior and anxiety questionnaires are completed again by their mothers. One month after the intervention, follow-up is performed.
Main outcome variables
Tendency to food diversity among children with avoidance / restriction of food; Anxiety in children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220128053843N1
Registration date:2022-03-22, 1401/01/02
Registration timing:retrospective
Last update:2022-03-22, 1401/01/02
Update count:0
Registration date
2022-03-22, 1401/01/02
Registrant information
Name
aboubakr karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3373 2001
Email address
aboubakr.karimi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-31, 1400/11/11
Expected recruitment end date
2022-03-02, 1400/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Measuring the Effectiveness of Group-Based Proper Nutrition-Training Therapy on Tendency to Food Diversity and Anxiety in Preschool Children with Avoidance / Restriction Disorders
Public title
educational nutrition package based on group play therapy for preschool children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having DSM5-based criteria for avoiding / avoiding eating disorders (such as being low in weight and energy and having some anxiety)
Children whose scores on each subscale of the Eating or Avoidance Problems Questionnaire are a standard deviation above average
Children who do not have a clear physical illness
They are between 3 and 5 years old
Failure to receive concomitant drug therapy for research purposes
Exclusion criteria:
Children who have been on medication, such as those taking anti-anxiety medications
Absence from more than two sessions in psychotherapy sessions.
Age
From 3 years old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
30 identified children with avoidance disorder / food restriction; They were organized in 2 groups of 15 (experimental and control) by simple randomization method. The following random number table was used for randomization:
First, the researcher's colleague determined to read the numbers in the table, from top to bottom. Next, he considered odd numbers for the experimental group and even numbers for the control group. Then he put his hand on one of the numbers and moved from top to bottom and recorded the numbers and assigned them to the experimental and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In a completely randomized manner, children were divided into two groups, in which the researcher did not know. But after dividing and forming groups because of 10 sessions, education is accepted by the plan of the plan, it is inevitably aware of the type of treatment. Children were notified after the formation of groups, which program is supposed to be implemented. Only an analysis of none of the processes, so the one-blind study will be
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Payame Noor University
Street address
saheli- Farhangian Town - Shayan Alley 10
City
Sanandaj
Province
Kurdistan
Postal code
6616978156
Approval date
2021-11-20, 1400/08/29
Ethics committee reference number
IR.PNU.REC.1400.242
Health conditions studied
1
Description of health condition studied
Avoidant-Restrictive Food Intake Disorder (ARFID)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Trends in children's food diversity based on Wardell, Guthrie, Sanderson and Rapaport (2001) Children Eating Behavior Questionnaire
Timepoint
Before intervention, after intervention, one month after intervention
Method of measurement
The Wardell, Guthrie, Sanderson, and Rapaport (2001) Children Eating Behavior Questionnaire was used.
2
Description
Reducing Child Anxiety Based on the Revised Childhood Anxiety Scale (CMAS) by Reynolds and Richmond (1987)
Timepoint
Before intervention, after intervention, one month after intervention
Method of measurement
The Revised Child Anxiety Scale (CMAS) by Reynolds and Richmond (1987) has been used.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention started with 2 group training sessions for mothers in the experimental group. Therapeutic group of young children with eating disorders; It requires the cooperation and serious participation of their mothers in the treatment process. For this reason, in the intervention, 2 sessions are provided for educating mothers. In the first session, parenting style and child nutrition were taught, and in the next session, a number of package therapy games were introduced and taught to mothers. The experimental group then received 120 minutes of 120 minutes of group nutrition training through play therapy. The titles of the intervention sessions are as follows:Healthy eating, dietary diversity, adding healthy eating concepts to the vocabulary, recognizing anxiety and relaxation education, developing interest in a variety of foods, teaching nutritional skills and eating habits, teaching problem-solving skills, preventing relapse .In each session, 2 games were played with children, and the names of the games are as follows:Knowing the types of food, dream pillows, guests playing and setting the table, breathing journey, what is wrong? I'm a turtle, an agricultural truck, pasta, playing card games, making bubbles, making a healthy meal, breathing gig, storytelling with pictures, running after talking, popcorn and the five senses.
Category
Treatment - Other
2
Description
Control group: The control group did not receive any intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Behzisti Organization
Full name of responsible person
Aref Rahimi
Street address
Bolvar Shebli
City
Sanandaj
Province
Kurdistan
Postal code
6616978156
Phone
+98 87 3373 2001
Email
aboubakr.karimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Research Assistant
Street address
Saheli
City
Sanandaj
Province
Kurdistan
Postal code
6616978156
Phone
+98 87 3182 2070
Email
aboubakr.karimi@yahoo.com
Web page address
https://acecr.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Iranian academic center for education culture and research
Full name of responsible person
Aboubakr Karimi
Position
PhD in Clinical Psychology - Governor Advisor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shayan 10 Ave, Farhangiyan- Saheli
City
Sanandaj
Province
Kurdistan
Postal code
6616978156
Phone
+98 87 3373 2001
Email
aboubakr.karimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan Governorate
Full name of responsible person
Aboubakr Karimi
Position
Adviser to the Governor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Saheli
City
Sanandaj
Province
Kurdistan
Postal code
6616978156
Phone
+98 87 3373 2001
Email
aboubakr.karimi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan Governorate
Full name of responsible person
Aboubakr Karimi
Position
Advisor to the Governor of Kurdistan
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Saheli
City
Sanandaj
Province
Kurdistan
Postal code
6616978156
Phone
+98 87 3373 2001
Email
aboubakr.karimi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the data, such as the main outcome, can be shared
When the data will become available and for how long
Start of access period 1 month after printing the results
To whom data/document is available
Anyone can
Under which criteria data/document could be used
Use of data, citing the source
From where data/document is obtainable
Email me
aboubakr.karimi@yahoo.com
What processes are involved for a request to access data/document
Up to one week after receiving the application, which will be sent to me via email, the files will be sent to the applicant.