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CompletedNCT06160063Updated Dec 7, 2023

Diabetes Acute Complications and Health Literacy in Children

An interventional study of Education intervention in Childhood, Diabetes and Health Literacy, sponsored by University of Yalova. Completed at 1 site in Turkey. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by University of Yalova · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study summary

In this study, in which education on acute complications of type 1 diabetes is planned with board games based on Bandura's social learning theory, children can indirectly learn common points that they may hear about acute complications of diabetes by watching board games of other group members. In line with this theory, children's knowledge needs regarding acute complications of diabetes can be determined, and interventions can be planned to meet the determined needs of children. Thus, the level of knowledge of diabetes health literacy for acute complications of diabetes can be increased.

This study will be carried out in a randomized controlled manner to evaluate the effect of educational play in children on acute complications of diabetes and health literacy.

Read the detailed description

This study was conducted to determine the Turkish validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" and to provide a diabetes health literacy box game to 8-12 school age children diagnosed with Type 1 diabetes. It will be carried out in two stages in order to evaluate the effect of educational games on acute complications of diabetes and health literacy in children.

In the first stage of the research, a general screening methodological method will be carried out to determine the current situation by quantitative analysis of the data obtained with the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 years)".

In the second stage; Randomly determined intervention and control groups will be applied to the intervention and control groups in a quasi-experimental type at the pre-test and the 1st and 3rd months after the training.

02

Conditions studied

  • Childhood
  • Diabetes
  • Health Literacy

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Keywords

  • Childhood
  • Diabetes
  • Health Literacy
  • Social Learning Theory
  • Board Game
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 75 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Yalova is the lead sponsor of 56 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diabetes age is at least one year
  2. Regular attendance to the three-month routine outpatient clinics
  3. Not having any other disease accompanying diabetes
  4. The child is between 8-12 years old

Exclusion criteria

Exclusion Criteria:

  1. Children not coming to the given appointment
  2. Children who do not play the diabetes health literacy (DISOY) board game at home
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Experimental group

    It is planned to meet with the experimental group 3 times in total. In the first interview, first of all, "Diabetes Child Diagnosis Form" and "Diabetes Health Literacy Scale for Acute Complications in Children" will be applied. Then the diabetes health literacy board game will be played. For this, groups of 4 will be formed and care will be taken to ensure that children of similar age groups are together while forming groups. In the clinic, they will be asked to play a diabetes health literacy (DISOY) board game in a quiet, bright room, a room with a table and 4 chairs. DISOY board game averages 45-60 minutes. and the first meeting will end here. Each child will be given one game to play with their parents at least twice at home. The second interview will be provided 1 month after the first interview. The third interview will be held in the third month. Data collection forms will be filled out again at each interview.

    Behavioral: Education intervention

  • No intervention
    control

    control group; It is planned to meet with the control group 3 times in total. In the first, second and third interviews, only the data collection forms will be filled by the children. After collecting all the data of the experimental group, a board game will be given to the parents and children in the control group.

Interventions

  • BehavioralEducation intervention

    Board game was created in line with current literature. In each interview, it is expected that the child's negative behaviors will be transformed into positive behaviors.

06

What researchers measure

Primary outcomes

  1. Validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" in Turkish

    The Turkish validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" was carried out. Scale items will be created by the researcher. The scale items will be presented to expert opinion and experts will be asked to evaluate the scale according to the Davis (1992) technique. Items that need to be revised will be reviewed and the final version of the scale will be created. Children who score higher on the scale will indicate a higher level of diabetes health literacy. The scale developed within the scope of the research will be filled in by children with diabetes themselves.

    Time frame: 6 month

  2. Evaluation of Literacy Scale for Acute Complications of Diabetesfor Children with Type 1 Diabetes (8-12 years)

    The diabetes health literacy of children with type 1 diabetes aged 8-12 years who participated in our research was evaluated with the "Literacy Scale for Acute Complications of Diabetes for Children with Type 1 Diabetes (8-12 years)" scale. The scale was applied to the participants at the first meeting. Then, diabetes education was given to the participants through games. The scale was re-administered to the participants 1 and 3 months after the training. Participants were advised to play the game at least twice between follow-ups.

    Time frame: Baseline, 4 weeks ve 12 weeks after randomization

07

Study locations

1 site
  • İstanbul İl Sağlık Müdürlüğü
    Istanbul, 34000, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06160063
Lead sponsor
University of Yalova
Responsible party
Fatma Yeşil (llecturer, University of Yalova) — Principal investigator
First posted
Dec 7, 2023
Start date
Jan 16, 2023
Primary completion
Mar 1, 2023
Completion
Jun 1, 2023
Last update
Dec 7, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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