AnemiaNCT03638557
School Lunch Program (SLP) Towards Nutrition Knowledge, Attitude, Practices and Nutrition Status of Adolescents
A study testing Nutritious Lunch in people with Anemia and Stunting, run by Institut Pertanian Bogor at 1 site in Indonesia.
Trial summary
The main objective of this study is to assess the impact of the school lunch program and nutrition education towards the change in knowledge, attitude, and behavior on balanced nutrition and clean and healthy lifestyle behavior (CHLB) of adolescents living in an Islamic Boarding School. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anemia, Stunting, Underweight
- What is being tested?
- Nutritious Lunch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 Jan 2018to Mar 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- have resided in the boarding school at least one year
- are anemic or underweight or stunted
Who cannot join
- severely anemic with Hb concentration < 7 g/dl
- BMI for age z-score <-3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of School Lunch Program (SLP) Towards Nutrition Knowledge, Attitude, Practices and Nutrition Status of Adolescents in Islamic Boarding School
The main objective of this study is to assess the impact of the school lunch program and nutrition education towards the change in knowledge, attitude, and behavior on balanced nutrition and clean and healthy lifestyle behavior (CHLB) of adolescents living in an Islamic Boarding School. The secondary objective is to assess the program impact on energy and nutrient intake, nutrition status, hemoglobin concentration, physical fitness and concentrating ability of students.
A pre-post quasi experimental design is applied to assess the impact. The intervention includes: 1) provision of nutritious lunch, meeting the nutrient requirements of adolescents for one meal, for 7 days a week, with the total duration of 220 days, 2) provision of nutrition education once a week (3 times delivered by teachers, 1 time delivered by research team) and nutrition education media, 3) capacity building of teachers and food handlers. The duration of the intervention is 1 academic year or 8 active months after the reduction of holidays and examination months.
Read the detailed description
This research will be conducted using pre-post quasi experimental design. Subjects consist of only intervention group, who are measured before and after the intervention or program period. The SLP program (intervention) in Darussalam Islamic Boarding School consists of:
- Balanced Nutrition Education and CHLB for the boarding school students and teachers
- Provision of lunch
- Food processing training, food sanitation hygiene and food safety for food handlers.
The location of this activity is determined purposively at the Islamic boarding school, in the neighborhood of the IPB (Institut Pertanian Bogor) campus with the following basic criteria for the school:
- Has apparent nutritional problems among the students
- It has a kitchen and dining area for its students in need of improvement
- Has a strong commitment to cooperate in running the program. This activity will be held at the Darussalam Islamic Boarding School located in Laladon Bogor area. There are 450 students consisting of both male and female students. This Islamic boarding school has a kitchen that is used to process and cook food for the students. The eating area is divided into two areas, in the form of a shared dining room for the male students and a terrace for the female students. The Islamic boarding school also has a garden area that is used for gardening activities for the students but it has not been managed in a sustainable manner.
The overall project period is 18 months (2017/09-2019/03), which includes design, baseline, midline and endline data collection (3 times), implementation and reporting activities. The implementation of the school lunch program will be for 1 academic year (8 active months after the reduction of holidays and examination months), starting immediately after Institutional Review Board (IRB) approval of both Bogor University and Ajinomoto co. inc.until the end of March 2019. Lunch will be served 7 days per week with the total of 220 days The provision of lunch is designed to meet 30% of the daily nutritional requirements of students and contains 635-776 Kcal of energy with 18-22 grams of protein. The lunch menu is served in the form of a full menu consisting of staple food, animal products, plant products, vegetables and fruit by utilizing local food. The menu cycle used is a set menu cycle of 10+1 day cycle Hemoglobin level and dietary intake data was collected for sub sample of students, meeting the sample size calculation, which was 150 subjects. Data will be collected at baseline (before the intervention), midline, and endline.
- Conditions
- Anemia, Stunting, Underweight
- Being tested
- Nutritious Lunch
- Medical subject headings
- Anemia, Growth Disorders, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritious LunchOther
The intervention package consists of the following;
- Balanced Nutrition and Clean and Healthy Lifestyle Behavior Education for the boarding school students (once a week with the duration of 30-60 minutes. 3 weeks are delivered by trained teachers, and 1 week by research team.
- Nutritious lunch, for 7 days a week. With the total of 220 days. The lunch menu is designed to meet 30% of the students RDA, which consists of 635-777 Kcal and 18-22 grams of protein
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention package consists of the following;
1. Balanced Nutrition and Clean and Healthy Lifestyle Behavior Education for the boarding school students (once a week with the duration of 30-60 minutes. 3 weeks are delivered by trained teachers, and 1 week by research team.
2. Nutritious lunch, for 7 days a week. With the total of 220 days. The lunch menu is designed to meet 30% of the students RDA, which consists of 635-777 Kcal and 18-22 grams of protein Receives: Other: Nutritious Lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration using Hemocue
Hemoglobin concentration of subjects measured using Hemocue
Measured: February-November (9 months)
Secondary outcomes (8)
Body Mass Index (BMI) for age z-score
Indicator of nutrition status of adolescents, measured by the assessment of weight and height of the subject. BMI for age z-score was calculated using World Health Organization (WHO) Anthro Plus Software
Measured: February-November (9 months)
Nutrition and health knowledge using validated-structured questionnaire
Knowledge on nutrition and clean and healthy lifestyle behavior
Measured: February-November (9 months)
Nutrition and health practices using validated-structured questionnaire
Practices related to nutrition and clean and healthy lifestyle behavior
Measured: February-November (9 months)
Nutrition and health attitude using validated-structured questionnaire
Attitude on nutrition and clean and healthy lifestyle behavior (values of subjects), measured by questionnaire asking whether they agree or disagree to statements on nutrition and health
Measured: February-November (9 months)
Nutrient intake using Semi Quantitative Food Frequency Questionnaire
Energy, protein, carbohydrate, fat, iron, zinc, and vitamin c intake. Assessed using 24 hour recall
Measured: February-November (9 months)
Food pattern using validated-structured questionnaire
Consumption of protein sources, vegetables, fruits, dairy products and beverages. Assessed using Food Frequency Questionnaire
Measured: February-November (9 months)
Physical Fitness based on the Indonesian Physical Fitness Test
A series of test using the Indonesian Physical Fitness Test, consisting of push up, sit up, high jump, sprint, and running 1000 m
Measured: February-November (9 months)
Concentration/ short term memory using memory cards based on Kustiyani 2005
Assessed using a set of cards to memorize with reduced duration of time
Measured: February-November (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start26 Jan 2018
- Primary completion5 Feb 2018
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre-post quasi experimental design
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pertanian Bogor
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Principal investigator, Reisi Nurdiani, SP, MSi, Institut Pertanian Bogor
- Investigators
- Dr. Rimbawan, Principal investigator, Department of Community Nutrition, Faculty of Human Ecology, Bogor Agricultural University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638557
- Sponsor's protocol ID
- SLP05/2018
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of School Lunch Program (SLP) Towards Nutrition Knowledge, Attitude, Practices and Nutrition Status of Adolescents in Islamic Boarding School
- ClinicalTrials.gov ID
- NCT03638557
- Acronym / sponsor ID
- SLP05/2018
- Conditions
- Anemia, Stunting, Underweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Institut Pertanian BogorUniversity, hospital or other
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- Mar 2019 (estimated)
- First posted
- 20 Aug 2018 (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.
The main objective of this study is to assess the impact of the school lunch program and nutrition education towards the change in knowledge, attitude, and behavior on balanced nutrition and clean and healthy lifestyle behavior (CHLB) of adolescents living in an Islamic Boarding School. The secondary objective is to assess the program impact on energy and nutrient intake, nutrition status, hemoglobin concentration, physical fitness and concentrating ability of students.
A pre-post quasi experimental design is applied to assess the impact. The intervention includes: 1) provision of nutritious lunch, meeting the nutrient requirements of adolescents for one meal, for 7 days a week, with the total duration of 220 days, 2) provision of nutrition education once a week (3 times delivered by teachers, 1 time delivered by research team) and nutrition education media, 3) capacity building of teachers and food handlers. The duration of the intervention is 1 academic year or 8 active months after the reduction of holidays and examination months.
Detailed description
This research will be conducted using pre-post quasi experimental design. Subjects consist of only intervention group, who are measured before and after the intervention or program period. The SLP program (intervention) in Darussalam Islamic Boarding School consists of:
- Balanced Nutrition Education and CHLB for the boarding school students and teachers
- Provision of lunch
- Food processing training, food sanitation hygiene and food safety for food handlers.
The location of this activity is determined purposively at the Islamic boarding school, in the neighborhood of the IPB (Institut Pertanian Bogor) campus with the following basic criteria for the school:
- Has apparent nutritional problems among the students
- It has a kitchen and dining area for its students in need of improvement
- Has a strong commitment to cooperate in running the program. This activity will be held at the Darussalam Islamic Boarding School located in Laladon Bogor area. There are 450 students consisting of both male and female students. This Islamic boarding school has a kitchen that is used to process and cook food for the students. The eating area is divided into two areas, in the form of a shared dining room for the male students and a terrace for the female students. The Islamic boarding school also has a garden area that is used for gardening activities for the students but it has not been managed in a sustainable manner.
The overall project period is 18 months (2017/09-2019/03), which includes design, baseline, midline and endline data collection (3 times), implementation and reporting activities. The implementation of the school lunch program will be for 1 academic year (8 active months after the reduction of holidays and examination months), starting immediately after Institutional Review Board (IRB) approval of both Bogor University and Ajinomoto co. inc.until the end of March 2019. Lunch will be served 7 days per week with the total of 220 days The provision of lunch is designed to meet 30% of the daily nutritional requirements of students and contains 635-776 Kcal of energy with 18-22 grams of protein. The lunch menu is served in the form of a full menu consisting of staple food, animal products, plant products, vegetables and fruit by utilizing local food. The menu cycle used is a set menu cycle of 10+1 day cycle Hemoglobin level and dietary intake data was collected for sub sample of students, meeting the sample size calculation, which was 150 subjects. Data will be collected at baseline (before the intervention), midline, and endline.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-post quasi experimental design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Nutritious LunchThe intervention package consists of the following; 1. Balanced Nutrition and Clean and Healthy Lifestyle Behavior Education for the boarding school students (once a week with the duration of 30-60 minutes. 3 weeks are delivered by trained teachers, and 1 week by research team. 2. Nutritious lunch, for 7 days a week. With the total of 220 days. The lunch menu is designed to meet 30% of the students RDA, which consists of 635-777 Kcal and 18-22 grams of protein |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- have resided in the boarding school at least one year
- are anemic or underweight or stunted
Key exclusion criteria (2 listed)
- severely anemic with Hb concentration < 7 g/dl
- BMI for age z-score <-3
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 |
|---|---|---|
| Nutritious LunchThe intervention package consists of the following; 1. Balanced Nutrition and Clean and Healthy Lifestyle Behavior Education for the boarding school students (once a week with the duration of 30-60 minutes. 3 weeks are delivered by trained teachers, and 1 week by research team. 2. Nutritious lunch, for 7 days a week. With the total of 220 days. The lunch menu is designed to meet 30% of the students RDA, which consists of 635-777 Kcal and 18-22 grams of protein | Other | Intervention |
Primary outcome
Hemoglobin concentration using Hemocue
Time frame: February-November (9 months)
Hemoglobin concentration of subjects measured using Hemocue
8 secondary outcomes
Body Mass Index (BMI) for age z-score
Time frame: February-November (9 months)
Nutrition and health knowledge using validated-structured questionnaire
Time frame: February-November (9 months)
Nutrition and health practices using validated-structured questionnaire
Time frame: February-November (9 months)
Nutrition and health attitude using validated-structured questionnaire
Time frame: February-November (9 months)
Nutrient intake using Semi Quantitative Food Frequency Questionnaire
Time frame: February-November (9 months)
Food pattern using validated-structured questionnaire
Time frame: February-November (9 months)
Physical Fitness based on the Indonesian Physical Fitness Test
Time frame: February-November (9 months)
Concentration/ short term memory using memory cards based on Kustiyani 2005
Time frame: February-November (9 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Related trials for Anemia
Active, not recruitingPhase 1/2
ALS20-101 Lentiviral Gene Therapy for Beta Thalassemia
Beta-Thalassemia
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Natural History of Acquired and Inherited Bone Marrow Failure Syndromes
Severe Aplastic Anemia, Telomere Biology Disorders
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.
Dr. Rimbawan principal investigator
Department of Community Nutrition, Faculty of Human Ecology, Bogor Agricultural 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 Nutritious Lunch in people with Anemia and Stunting, run by Institut Pertanian Bogor 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Aug 2018. 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?
Results are not available in the source record.
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?
Hemoglobin concentration using Hemocue (time frame: February-November (9 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 20 Aug 2018.