Outcomes of a Game-based Educational Intervention: Healthy Kids

April 24, 2025 updated by: Lacin Aksoy, Marmara University

Effectiveness of a Role-play Based School Intervention in Primary School Students: a Non-randomized Cluster Controlled Trial

235 / 5.000 Investigators aimed to reduce the risk of obesity by trying a new intervention method that is role-play based, interactive and fun with age-appropriate play materials, considering that learning through play is more efficient.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

It was aimed to reduce the risk of obesity by trying a new intervention method based on role-play, interactive and fun with age-appropriate game materials, considering that learning through play is more efficient.

Two schools were determined as control and intervention groups. An 8-week interactive-game-based intervention program will be applied to children in the intervention group who are at risk for obesity. The program was shaped by a physician-dietician-psychologist and a professional theater actor.

Family Nutrition and Physical Activity (FNPA) score, Food index (FI) score and BMI will be grouped for each child and a risk score will be calculated based on the total score they receive. It will be checked whether there is a decrease in this score after the training.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All participants who do not meet the criteria of whether or not they agree to participate in the study will be included in the study.

Exclusion Criteria:

  • neurodevelopmental delays
  • metabolic disorders potentially leading to obesity
  • physical disabilities
  • those whose parents or guardians declined participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
A training was conducted only once, which did not include play and role play and provided information
Experimental: Intervention group
Two schools were determined as control and intervention groups. An 8-week interactive-game-based intervention program will be applied to children in the intervention group who are at risk for obesity. The program was shaped by a physician-dietician-psychologist and a professional theater actor physician.
Behavioral: Healthy Kids Programme
Our intervention was prepared by adopting an interactive curriculum shaped on role-play with visual materials and toy models of foods appropriate for the age of the children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI (body mass index)
Time Frame: All measurements will be collected at 0, 3 and 6 months
We inputted the height and weight measurements into the WHO( World Health Organization) AntroPlus tool and assessed the BMI z-score. We will group the participants as underweight-normal, overweight, obese and morbidly obese.
All measurements will be collected at 0, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FNPA scores
Time Frame: All measurements will be collected at 0, 3 and 6 months
Researchers will distribute the Family Nutrition and Physical Activity (FNPA) scale to parents. Parents will collect the questionnaires after they complete them. Children who score high on the FNPA scales are thought to have protective family behaviors against obesity. There is no cut-off point for the scale.
All measurements will be collected at 0, 3 and 6 months
FI Scores
Time Frame: All measurements will be collected at 0, 3 and 6 months

Researchers will collect data by distributing the Food Index to families and collecting it.

A high score on the Food Index is known to protect against obesity. There is no cut-off point for the index.
All measurements will be collected at 0, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Director: Arzu uzuner, Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-FM-LA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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