NCT06954545

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 14, 2025

Last Update Submit

April 24, 2025

Conditions

Keywords

educational interventionprevention of obesity

Outcome Measures

Primary Outcomes (1)

  • BMI (body mass index)

    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 Outcomes (2)

  • FNPA scores

    All measurements will be collected at 0, 3 and 6 months

  • FI Scores

    All measurements will be collected at 0, 3 and 6 months

Study Arms (2)

control group

NO INTERVENTION

A training was conducted only once, which did not include play and role play and provided information

Intervention group

EXPERIMENTAL

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

Interventions

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

Intervention group

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Pendik, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Arzu uzuner

    Marmara University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: intervention group with healthy kids programme, control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 14, 2025

First Posted

May 1, 2025

Study Start

May 1, 2025

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations