Obesity and OverweightNCT06954545
Outcomes of a Game-based Educational Intervention: Healthy Kids
A study testing Healthy Kids Programme in people with Obesity and Overweight and Child Health, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight, Child Health, Physical Activity
- What is being tested?
- Healthy Kids Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- neurodevelopmental delays
- metabolic disorders potentially leading to obesity
- physical disabilities
- those whose parents or guardians declined participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University
Istanbul, Pendik, 34890
lacin aksoy, drlacinaksoy@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity and Overweight, Child Health, Physical Activity
- Being tested
- Healthy Kids Programme
- Keywords
- educational intervention, prevention of obesity
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Kids ProgrammeBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Healthy Kids Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All measurements will be collected at 0, 3 and 6 months
Secondary outcomes (2)
FNPA scores
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.
Measured: All measurements will be collected at 0, 3 and 6 months
FI Scores
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.
Measured: All measurements will be collected at 0, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- intervention group with healthy kids programme, control group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lacin Aksoy, Marmara University
- Investigators
- Arzu uzuner, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954545
- Sponsor's protocol ID
- MU-FM-LA-01
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Role-play Based School Intervention in Primary School Students: a Non-randomized Cluster Controlled Trial
- ClinicalTrials.gov ID
- NCT06954545
- Acronym / sponsor ID
- MU-FM-LA-01
- Conditions
- Obesity and Overweight, Child Health, Physical Activity
- Keywords
- educational intervention, prevention of obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention group with healthy kids programme, control group
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –A training was conducted only once, which did not include play and role play and provided information |
| Intervention group | Experimental | Behavioral: Healthy Kids ProgrammeTwo 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. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- neurodevelopmental delays
- metabolic disorders potentially leading to obesity
- physical disabilities
- those whose parents or guardians declined participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Kids ProgrammeOur 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 | Behavioural | Intervention group |
Primary outcome
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.
2 secondary outcomes
FNPA scores
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arzu uzuner study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Kids Programme in people with Obesity and Overweight and Child Health, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lacin Aksoy (+905543969627, drlacinaksoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (body mass index) (time frame: All measurements will be collected at 0, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.