The impact of nutrition standards for school meals on the diets of schoolchildren in Cambodia
| ISRCTN | ISRCTN79659112 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79659112 |
- Submission date
- 18/10/2023
- Registration date
- 30/10/2023
- Last edited
- 19/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Developing and implementing robust nutrition standards to ensure that meal composition is adequate for the nutrition requirements of targeted students has been identified as a key need for the school meal programme in Cambodia. The proposed study is embedded within a project that is currently developing a methodology for countries to set context-specific and data-driven nutrition standards for their school meal programmes. The project is implemented by the Food and Agriculture Organization of the United Nations (FAO) and the World Food Programme (WFP). The study aims to assess the effects of school meals that comply with robust nutrition standards on the diet outcomes of schoolchildren when compared to usual school meals.
Who can participate?
Children aged 9-11 years (at the time of baseline) enrolled in selected schools in Cambodia, who do not have any food allergies or intolerances
What does the study involve?
Schools are randomly allocated to an intervention group, where school meals will be prepared according to nutrition standards, or a control group, where students will receive their regular school meals. Dietary assessments are collected from children aged 9-11 years old at the start of the study and at the end of the intervention period of about 3 months.
What are the possible benefits and risks of participating?
There are no foreseen risks for the participating children. Children in the control group will continue to receive their usual school meals, while children in intervention schools will receive school meals that are nutritionally adequate for their context, preferences and needs.
Where is the study run from?
1. Food and Agriculture Organization of the United Nations (Rome and Cambodia)
2. Helen Keller International (Cambodia)
When is the study starting and how long is it expected to run for?
July 2022 to September 2024
Who is funding the study?
Federal Ministry of Food and Agriculture (Germany)
Who is the main contact?
Melissa Vargas, melissa.vargas@fao.org
Contact information
Scientific, Principal Investigator
Viale delle Terme di Caracalla
Rome
00145
Italy
 ORCID ID |
0000-0001-5865-7468 |
|---|---|
| Phone | +39 (0)657056923 |
| melissa.vargas@fao.org |
Public, Scientific, Principal Investigator
Viale delle Terme di Caracalla
Rome
00145
Italy
| ORCID ID |
0000-0003-0071-7266 |
|---|---|
| Phone | +3906570 55735 |
| fatima.hachem@fao.org |
Study information
| Study design | Cluster randomized controlled trial with two parallel group design with a 1:1 allocation ratio and with randomization at school level |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A cluster randomized trial to assess the impact of school meals compliant with nutrition standards on the diet quality of Cambodian schoolchildren |
| Study objectives | School meals that comply with context-specific and evidence-based nutrition standards have better diet quality outcomes than school meal that do not follow nutrition standards |
| Ethics approval(s) |
1. Approved 27/02/2023, Cambodia Ministry of Health's National Ethics Committee for Health Research (80 Samdach Penn Nouth Blvrd (289), Sangkat Boeung Kok 2, Khan Tuol Kork, Phnom Penh, 120408, Cambodia; +855 (0)12 528789; nouthsarida@gmail.com), ref: N 061 NECHR 2. Approved 30/04/2024, Cambodia Ministry of Health's National Ethics Committee for Health Research (80 Samdach Penn Nouth Blvrd (289), Sangkat Boeung Kok 2, Khan Tuol Kork, Phnom Penh, 120408, Cambodia; +855 (0)12 528789; nouthsarida@gmail.com), ref: N 087 NECHR |
| Health condition(s) or problem(s) studied | Diet modification |
| Intervention | Current interventions as of 18/03/2024: All children from 40 selected schools (according to pre-defined criteria) in three regions in Cambodia will be randomly allocated to an intervention arm or to a control arm (1:1 ratio) using covariate constrained randomization. The schools assigned to the intervention will receive school meals prepared according to robust nutrition standards as a substitute for their usual school meals as well as a complementary food education strategy, while control schools will continue to receive their usual school meals. The intervention will last for 3 months and the meals will be prepared by the usual school cooks. Dietary measures have been collected from 20 randomly selected eligible children in each of the 40 schools at baseline (before allocation) and will be repeated at the end of the intervention period. _____ Previous interventions: All children from 40 selected schools (according to pre-defined criteria) in three regions in Cambodia will be stratified and randomly allocated to an intervention arm or to a control arm (1:1 ratio) using pair matching. The schools assigned to the intervention will receive school meals prepared according to robust nutrition standards as a substitute for their usual school meals, while control schools will continue to receive their usual school meals. The intervention will last for 3 months and the meals will be prepared by the usual school cooks. Dietary measures have been collected from 20 randomly selected eligible children in each of the 40 schools at baseline (before allocation) and will be repeated at the end of the intervention period. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 19/08/2024: 1. Differences from baseline between treatment arms at the endline in habitual daily intake (grams) of fruits; vegetables; meat, poultry, fish and eggs; and snack foods rich in salt, sugar and fat (including sugar-sweetened beverages, processed salty foods, grain-based and other sweets) Previous primary outcome measure as of 18/03/2024 to 19/08/2024: 1. Differences between treatment arms at endline in habitual daily intake (grams) of fruits; vegetables; meat, poultry, fish and eggs; and snack foods rich in salt, sugar and fat (including sugar sweetened beverages, processed salty foods, grain-based and other sweets) _____ Previous primary outcome measure: 1. Daily consumed grams of total fruits, total vegetables, animal source foods, and snack foods, measured via 24-hour recall at baseline and the end of the intervention period 2. Contribution of school meals to daily consumed grams of fruits, vegetables, animal source foods and legumes and snack foods, measured via 24-hour recall and weighed food record at baseline and the end of the intervention period 3. Dietary diversity scores, measured via 24-hour recall at baseline and the end of the intervention period |
| Secondary outcome measures | Current secondary outcome measures as of 19/08/2024: 1. Differences from baseline between the two treatment arms at the endline in usual energy (kcal) intake and estimated habitual daily intake and prevalence of inadequacy of protein (grams), fibre (grams), vitamin A (micrograms), vitamin C (milligrams), calcium (milligrams), iron (milligrams) and zinc (milligrams). 2. Differences from baseline between the two treatment arms at the endline in usual intake (grams) of fruits, vegetables; meat, poultry, fish and eggs; and snack foods rich in salt, sugar and fat, obtained from the home diet (i.e. excluding the school meal). Other outcomes 3. Difference between the two treatment arms at the endline in weighed total mean plate waste from school meals 4. Difference between the two treatment arms at the endline in mean proportion of weighed plate waste relative to total served meal weight 5. Differences between the two treatment arms at three intervention points (once every month of the intervention) in mean hedonic ratings of meal liking. 6. School-level adherence to the prescribed menus, calculated as the average number of compliance days in each intervention school during the three-month period 7. Dose received of the intervention, calculated as the average number of days in which children in each intervention school received the meals during the three-month period 8. Main implementation barriers and enablers in intervention schools identified at post-intervention _____ Previous secondary outcome measures as of 18/03/2024 to 19/08/2024: 1. Differences between the two treatment arms at endline in mean energy (kcal) and estimated habitual daily intake of protein (grams), fibre (grams), vitamin A (micrograms), vitamin C (milligrams), calcium (milligrams), iron (milligrams) and zinc (milligrams). 2. Differences between the two treatment arms at endline in mean intake (grams) of fruits, vegetables; meat, poultry, fish and eggs; and snack foods rich in salt, sugar and fat, obtained from the home diet (i.e. excluding the school meal). Other outcomes 3. Difference between the two treatment arms at endline in weighed total mean plate waste from school meals 4. Difference between the two treatment arms at endline in mean proportion of weighed plate waste relative to total served meal weight 5. Differences between the two treatment arms at three intervention points (once every month of the intervention) in mean hedonic ratings of meal liking. 6. School-level adherence to the prescribed menus, calculated as the average number of compliance days in each intervention school during the three-month period 7. Dose received of the intervention, calculated as the average number of days in which children in each intervention school received the meals during the three-month period 8. Main implementation barriers and enablers in intervention schools identified at post-intervention _____ Previous secondary outcome measures: 1. Estimated mean daily intake of energy, protein, saturated fat, sugar, fibre, vitamin A, iron and zinc, measured via 24-hour recall (repeated in a subsample) at baseline and the end of the intervention period 2. Contribution of school meals to daily estimated intake of energy, protein, saturated fat, sugar, fibre, vitamin A, iron and zinc, measured via 24-hour recall (repeated in a subsample) and weighed food records at baseline and the end of the intervention period |
| Overall study start date | 06/07/2022 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 9 Years |
| Upper age limit | 11 Years |
| Sex | Both |
| Target number of participants | 800 students (20 students in 40 schools/clusters) |
| Total final enrolment | 800 |
| Key inclusion criteria | 1. Students aged 9 to 11 years old from the selected schools 2. Students receiving school meals |
| Key exclusion criteria | 1. Students with grave intolerances or food allergies 2. Students with health conditions that may affect their food consumption |
| Date of first enrolment | 15/03/2023 |
| Date of final enrolment | 10/06/2023 |
Locations
Countries of recruitment
- Cambodia
Study participating centres
Kampong Chhnang
040201
Cambodia
Pursat
150301 and 150201
Cambodia
Oddar Meanchey
240501
Cambodia
Sponsor information
Other
Viale delle Terme di Caracalla
Rome
00145
Italy
| Phone | +39 (0)6 57051 |
|---|---|
| FAO-HQ@fao.org | |
| Website | http://www.fao.org/home/en/ |
"ROR" |
https://ror.org/00pe0tf51 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Food and Agriculture, Federal Ministry of Food and Agriculture (Germany), BMEL
- Location
- Germany
Results and Publications
| Intention to publish date | 30/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication of protocol in BMC Public Health, and results of the cluster trial in a high-impact peer-reviewed journal. Results from the trial will also be presented to Cambodian authorities in multistakeholder workshops. Results will also be disseminated in major nutrition conferences in 2025-2026 |
| IPD sharing plan | Data obtained will be coded to avoid any potential loss of confidentiality. All potentially sensitive findings will be reported in a way that they cannot be traced to any individual. All raw and processed datasets will be stored in a non-publicly available FAO repository. Some of the dietary datasets generated during and/or analyzed during the current study will be made available in the FAO/WHO GIFT platform (which collects data sets on individual food consumption). |
Editorial Notes
19/08/2024: The primary and secondary outcome measures were changed.
14/08/2024: The following changes were made:
1. Ethics approval added.
2. The overall study end date was changed from 30/07/2024 to 30/09/2024.
18/03/2024: The following changes were made to the trial record:
1. The study design was changed from "Cluster randomized trial with two parallel group design with a 1:1 allocation ratio" to "Cluster randomized controlled trial with two parallel group design with a 1:1 allocation ratio and with randomization at school level".
2. The overall end date was changed from 30/06/2024 to 30/07/2024.
3. The interventions were changed.
4. The primary outcome measure was changed.
5. The secondary outcome measures were changed.
6. The plain English summary was updated to reflect these changes.
23/10/2023: Study's existence confirmed by the Cambodia Ministry of Health's National Ethics Committee for Health Research.
