NCT05894174

Brief Summary

The purpose of this study to design a board game that will enable primary school children to recognize foods by enabling them to distinguish between healthy and unhealthy foods by going beyond the traditional education patterns and to compare the effects of this board game-based nutrition education intervention on children's behaviors, self-efficacy, and attitudes with the control group in which no intervention was made.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 19, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

14 days

First QC Date

May 18, 2023

Last Update Submit

June 16, 2023

Conditions

Keywords

Dietary IntakeBehaviorSelf EfficacyAttitude

Outcome Measures

Primary Outcomes (3)

  • Change in Food Behavior Scale (FBS)

    It was developed to measure children's habit of consuming low-fat/salt foods in contrast to high-fat/salt food options. A validity and reliability study was conducted (Cronbach's alpha coefficient 0.68). The items of the scale consisting of 14 questions with 2 options take a value of -1 for unhealthy food and +1 for healthy food and the total score varies between -14 and +14. A high total score on the scale indicates healthy eating habits.

    Baseline and four weeks

  • Change in Children's Dietary Self- Efficacy Scale (CDSS)

    It was developed to measure children's self-confidence to choose low-fat and low-salt foods despite the fatty and salty food options. A reliability and validity study was conducted (Cronbach's alpha coefficient 0.79). It is a 3-point Likert-type scale consisting of 15 items. Scale items can be scored between -1 and +1 (-1: not sure, 0: somewhat sure, +1: very sure) and the total score varies between -15 and +15. A high total score on the scale indicates a high self-efficacy value.

    Baseline and four weeks

  • Change in Nutrition Attitude Subscale (NAS)

    It's the nutrition-related subscale of the Child Heart Health Promotion Attitude Scale, which normally consists of 4 subscales with 16 questions. The aim of the scale is to assess the heart health promotion attitudes of school-age children. The validity and reliability of this Likert-type scale has been studied (Cronbach's alpha coefficient 0.68). In the study, the scale consists of 4 questions and the scale items are scored as 1 "strongly disagree" and 4 "strongly agree" and the total score that can be obtained varies between a minimum of 4 and a maximum of 16 points. A high total score indicates a positive attitude.

    Baseline and four weeks

Secondary Outcomes (1)

  • Change in The Food Frequency Questionnaire (FFQ)

    Baseline and four weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group refers to the group that will the "Food Hunter" board game intervention developed by the researchers to enable children to recognize healthy and unhealthy foods; to learn what vitamins and minerals are necessary for children in the growth and development period, their effects on our health and in which foods they are found.

Behavioral: Board Game

Control Group

NO INTERVENTION

The control group refers to the group that will not receive any nutrition education intervention.

Interventions

Board GameBEHAVIORAL

Food Hunter board game intervention, which includes various nutrient cards and question cards and is played with pawns and dice, will be played with children for approximately 4 weeks, one day a week and one session (40 minutes) with the researcher dietitian. By talking about the nutrients in the game on the game cards, children will be able to recognize the nutrients and important points will be emphasized for the participants with the answers to the cards containing various questions about healthy nutrition.

Intervention Group

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • In the 3 schools where the study will be carried out
  • th grade student
  • Does not have any physical disability related to vision, hearing and speech
  • Without any chronic or metabolic disease

You may not qualify if:

  • Having any chronic or metabolic disease
  • Can't read and write

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beyzanur Çamlıbel

Istanbul, Gaziosmanpaşa, 34240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Child BehaviorBehavior

Study Officials

  • Beyzanur Çamlıbel

    Istanbul Kent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by a investigator who was blinded to group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups with the intervention group in which the game was applied and the control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 18, 2023

First Posted

June 8, 2023

Study Start

May 19, 2023

Primary Completion

June 2, 2023

Study Completion

June 15, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations