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NCT Number: NCT06515288

Nutrition Goes to School: a School-based Nutrition Intervention to Promote Healthy Eating Behaviour Among Adolescents

The goal of this cluster randomized controlled pilot trial is to assess the feasibility and effect of a school-based nutrition intervention program called "Nutrition Goes to School" (NGTS) in improving a healthy diet and physical activities as part of the prevention and management of obesity among adolescents in urban Indonesia. The main questions it aims to answer concern the feasibility of the NGTS multi-component school-based nutrition intervention model in selected secondary schools in an urban setting to inform the design of the future effectiveness study. Additionally, it aims to evaluate the effect of the school-based nutrition intervention in the healthy eating knowledge and behavior (fruit and vegetable consumption, energy-dense nutrient poor food, and sugary beverages consumption, as measured by food frequency questionnaire) and physical activities as well as its effect on nutrition status (body mass index, mid-upper arm circumference [MUAC] and waist circumference). The intervention components consist of nutrition education to school communities (teachers, management, students and parents), healthy school canteen, school garden, hygiene and sanitation promotion of the school environment and obesogenic environment control, and promotion of physical activities among students. Five secondary schools in Jakarta will be randomly assigned to receive the intervention for 6 months, and five other schools will serve as the control group.

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Key information

Age range

15 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seameo Recfon

Jakarta, The Special Capital Region of Jakarta, 13120, Indonesia

Location status: Recruiting

Location contact

Indah S Widyahening, Professor

CONTACT

[email protected]

Ratna Wulanti

CONTACT

[email protected]

About this study

A program which is called "Nutrition Goes to School" (NGTS) has been initiated by the Southeast Asian Ministers of Education Organization Regional Centre for Food and Nutrition (SEAMEO RECFON) in 2016 to improve the health of the children through implementation of nutrition good practices at schools.The program was started by providing training to school teachers about nutrition and continuously improved until it currently includes multiple components consisting of school readiness survey, healthy school canteen, school garden for nutrition literacy, nutrition education, school hygiene and sanitation promotion and promotion of physical activities at school.

Since its initiation in mid-2016, some schools from primary to secondary level in several provinces in Indonesia have been trained in the implementation of some components of the program. However, since the program was developed gradually and schools' participation is on voluntary basis, no schools participated in the training currently implement the whole components, no standard protocol for the activities was implemented and an impact assessment is yet to been conducted. SEAMEO RECFON is one of the regional organizations under the Ministry of Education in Association of South-east Asian Nations (ASEAN) member countries which effort focused on the human resources development through education, research and community development activities in food and nutrition area. Evidence on the effectiveness of the NGTS as the flagship program of the institution is needed to advocate the implementation of the program nationally and even regionally among the ASEAN member countries.

A cluster randomized controlled pilot trial among secondary school in Jakarta, Indonesia. The school-based nutrition intervention which consisted of multi-components could be regarded as a complex health intervention. Therefore, evaluation of its effectiveness follows the steps suggested by the UK Medical Research Council (MRC) whom devised a four-phase framework for developing and evaluating RCT's of complex interventions. This pilot trial is the 2nd phase of the framework, which will be guided by the result of the program evaluation, and aimed to assess the adherence to the whole NGTS package, determine intra-cluster correlation coefficients and effect estimates. This stage is important to inform sample size calculations for future definitive trials designed to assess the effectiveness and cost-effectiveness of a full-scale intervention as currently high-quality controlled trial on school-based health intervention in Indonesia is still lacking.

Study population is adolescents (grade 10-11; 15-17 years old) in Jakarta from ten schools (five intervention and five control);each school consisted of at least 100 students. To accommodate the Indonesian school system in urban areas, we will intentionally select schools from Jakarta Provinces, which cover 5 different municipalities, North Jakarta, East Jakarta, South Jakarta, Central Jakarta, and West Jakarta. First, recruitment will be based on the discussion with the local education office at the provincial level and ask for a list of schools considering eligibility criteria, such as having a school canteen, implementing the School Health Program (Usaha Kesehatan Sekolah/UKS), and having potential land to be utilized as a school garden. Two schools in each municipality with comparable characteristics will be selected, and then each pair will be randomized to become either the intervention or the control group. Second, selected schools will be invited to participate in the study. The intervention group will receive baseline educational intervention (Nutrition Education Capacity Building for Teachers and Management) and all components of the NGTS program. While the control group will receive only the baseline educational intervention. The baseline educational intervention will be conducted in 5 days through face-to-face delivery training mode.

The sample size for this study was determined using the formula from Hayes R and Bennett S (1999). Determination of the calculation of the main parameter assessed was based on a prior study in Ecuador of a school-based intervention to improve dietary intake outcomes, the proportion of breakfast intake. Randomization was based on the number of clusters with a total of 10 schools, considering the significant level (α) of 0.05, the coefficient of variation between groups (Intra Class Correlation/ICC) of 0.15, the power of study (β) of 80%, the ratio of cases and controls (k = 1), and the anticipated dropout of 10%. Based on the sample calculation, the number of samples per intervention group and control group was 486 people each, which was increased to 500 people. So that the total sample needed is 1,000 people, with each school consisting of 100 students.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • High school students in grades 10-11
  • Aged 15-17 years
  • Attending school in Jakarta

Exclusion criteria

  • unwilling and/or unable to complete the questionnaire thoroughly

Treatment and study plan

Nutrition Goes To School (NGTS) Program Intervention Package

Behavioral

The NGTS Program intervention package in this project consists of four components:

  • A comprehensive Nutrition Education to improve healthy eating, physical activity, and hygiene-sanitation practices.

This is a weekly interactive and fun nutrition and health promotion with different kinds of activities.

  • Healthy School Canteen to improve the availability of healthy food in school. This is an effort to strengthen the school canteen referring to the 4 Pillars of a Healthy School Canteen, including School Commitment and Management, Human Resources, Facilities and Infrastructure, and Food Quality.
  • School Garden. This is a gardening activity as a form of school garden as a media for nutrition education, character building, and contribute to supply vegetables during cooking class sessions in school.
  • Entrepreneurship nutrition. Entrepreneurship nutrition aims to foster entrepreneurial potential and skills among school members in providing healthy food at school.

Nutrition Education Capacity Building for Teachers and Management

Behavioral

The intervention schools will receive Nutrition Education Capacity Building for Teachers and School Management, before the above four NGTS components is implemented in the respective school. Three representatives from each school will be invited to attend a 5-day training that include knowledge on adolescent nutrition and health issues, as well as skills in implementing the NGTS Program.

Primary outcomes

  1. Knowledge on healthy diet among children - clinical outcome

    Time frame: at baseline and 6 months

    Multiple choices' questionnaire

    Analyzed as Comparison of score (mean difference [MD] and 95% CI):

    • before and after the intervention
    • between the intervention and control schools
  2. Eating attitude-clinical outcome

    Time frame: at baseline and 6 months

    The Eating Attitudes Test (EAT-26)

    Analyzed for a comparison of proportion eating disorder (difference and 95% CI):

    • before and after the intervention
    • between the intervention and control schools
  3. Healthy diet behaviour-clinical outcome

    Time frame: at baseline and 6 months

    Fruits and vegetables, energy-dense nutrient poor food and sugary beverages consumption using semi-quantitative food frequency questionnaire (FFQ)

    Analyzed for a comparison of proportion (difference and 95% CI):

    • before and after the intervention
    • between the intervention and control schools
  4. Physical activity-clinical outcome

    Time frame: at baseline and 6 months

    Rapid Assessment of Physical Activities (RAPA)

    Comparison of proportion (difference and 95% CI):

    • before and after the intervention
    • between the intervention and control schools
  5. Nutritional status-clinical outcome

    Time frame: at baseline and 6 months

    Body Mass Index (BMI) for Age

  6. mid-upper arm circumference (MUAC)

    Time frame: at baseline and 6 months

    Nutritional status-clinical outcome

  7. waist circumference

    Time frame: at baseline and 6 months

    Nutritional status-clinical outcome

Secondary outcomes

  1. School readiness on the implementation of the program - - Descriptive, Quantitative (proportion), Qualitative

    Time frame: Baseline

    Data source : School readiness questionnaire (Likert scale; validated)

  2. Attendance of teachers to training sessions-proportion

    Time frame: at the end of the three days training

    Data source: Training attendance list

  3. Activity report completed-proportion

    Time frame: during the 6-month of intervention

    Data source: NGTS monitoring dashboard

  4. Adherence to NGTS protocol - Descriptive, Quantitative (proportion), Qualitative

    Time frame: during the 6-month intervention

    Data source: NGTS monitoring dashboard, interview, and observation by the field coordinator

  5. Students' and teachers' preference and acceptance on IEC material/modules - Qualitative

    Time frame: during the 6-month intervention

    Data source: FGD's guidelines

Study contacts

Contact information is provided by the study sponsor or research team.

Indah S Widyahening, Professor

CONTACT

[email protected]

+622122116225

Sponsors and collaborators

Lead sponsor

SEAMEO Regional Centre for Food and Nutrition

Other

Collaborators

  • Fakultas Kedokteran Universitas Indonesia

Registry information

Official study title

The Effect of a School-based Nutrition Intervention to Promote Healthy Eating Behaviour Among Adolescents in Indonesia - a Cluster Randomized Pilot Study

Acronym: ESTEEM-NGTS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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