Children Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and TeacherNCT03910257
Nutrition Education Module for Preschooler Children
A study testing nutrition education module in people with Children Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and Teacher, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.
Trial summary
This study evaluates the knowledge of preschooler children before and after intervention of nutrition education using nutrition education module for preschooler children. The teachers will be given training regarding the module and deliver it in the class during the intervention. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Children Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and Teacher
- What is being tested?
- nutrition education module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2019to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children registered in selected public kindergarten
- grade/class B kindergarten
- willing to follow the study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effectiveness of Nutrition Education Module to Knowledge of Preschooler Children in Public Kindergarten at 3 Districts of Riau Province
This study evaluates the knowledge of preschooler children before and after intervention of nutrition education using nutrition education module for preschooler children. The teachers will be given training regarding the module and deliver it in the class during the intervention.
Read the detailed description
A nutrition education module for preschooler children had been developed in the previous study. The module consists of 3 topics of nutrition (my meal plate, fruits and vegetables, healthy snacks). Each topic consists of 4 activities engaging children and teachers. A total of 12 activities will be delivered on 4 consecutive school day every week.
The teacher will deliver the nutrition education which trained prior to the study.
- Being tested
- nutrition education module
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition education moduleBehavioural
12 activities of nutrition education module will deliver by the teacher. The activities consists of coloring my meal plate, playing pictures, story telling: Zizi and Ziko, pictures station, fruits and vegetables card, cooking class, planting bean sprouts, field visit to fruits and vegetables garden, making collages, dot to dot, watching video, making healthy snacks
| Study group | Role | What they receive |
|---|---|---|
| nutrition education module | Experimental | 12 activities of the nutrition education module pre and post test Receives: Behavioral: nutrition education module |
| control group | No intervention | no intervention pre and post test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on nutrition related knowledge before and after intevention
a self administered structured questionnaire regarding nutrition related knowledge (my meal plate, fruits and vegetables, healthy snacks) using pictures yielding a total score between 0-100
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 May 2019
- Primary completion10 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and TeacherStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- a quasi-experimental research design with pre-and post-test control group design
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEAMEO Regional Centre for Food and Nutrition
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muharni Harahap, SEAMEO Regional Centre for Food and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910257
- Sponsor's protocol ID
- modul gizi
- Status last verified
- Sep 2019
- First submitted
- 4 Apr 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effectiveness of Nutrition Education Module to Knowledge of Preschooler Children in Public Kindergarten at 3 Districts of Riau Province
- ClinicalTrials.gov ID
- NCT03910257
- Acronym / sponsor ID
- modul gizi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- SEAMEO Regional Centre for Food and NutritionUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 10 Apr 2019 (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.
This study evaluates the knowledge of preschooler children before and after intervention of nutrition education using nutrition education module for preschooler children. The teachers will be given training regarding the module and deliver it in the class during the intervention.
Detailed description
A nutrition education module for preschooler children had been developed in the previous study. The module consists of 3 topics of nutrition (my meal plate, fruits and vegetables, healthy snacks). Each topic consists of 4 activities engaging children and teachers. A total of 12 activities will be delivered on 4 consecutive school day every week.
The teacher will deliver the nutrition education which trained prior to the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a quasi-experimental research design with pre-and post-test control group design
| Arm | Type | Receives |
|---|---|---|
| nutrition education module | Experimental | Behavioral: nutrition education module12 activities of the nutrition education module pre and post test |
| control group | No intervention | –no intervention pre and post test |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children registered in selected public kindergarten
- grade/class B kindergarten
- willing to follow the study
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| nutrition education module12 activities of nutrition education module will deliver by the teacher. The activities consists of coloring my meal plate, playing pictures, story telling: Zizi and Ziko, pictures station, fruits and vegetables card, cooking class, planting bean sprouts, field visit to fruits and vegetables garden, making collages, dot to dot, watching video, making healthy snacks | Behavioural | nutrition education module |
Primary outcome
Changes on nutrition related knowledge before and after intevention
Time frame: 3 weeks
a self administered structured questionnaire regarding nutrition related knowledge (my meal plate, fruits and vegetables, healthy snacks) using pictures yielding a total score between 0-100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: Yes
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition education module in people with Children Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and Teacher, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2019. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on nutrition related knowledge before and after intevention (time frame: 3 weeks). 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 19 Sep 2019.