Nutrition Goes to School: a School-based Nutrition Intervention to Promote Healthy Eating Behaviour Among Adolescents (ESTEEM-NGTS)

July 22, 2024 updated by: Indah Widyahening, SEAMEO Regional Centre for Food and Nutrition

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention schools
The intervention group will receive baseline educational intervention (Nutrition Education Capacity Building for Teachers and Management) and all components of the Nutrition Goes to School (NGTS) program.
Behavioral: Nutrition Goes To School (NGTS) Program Intervention Package

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

  1. 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.

  2. 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.
  3. 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.
  4. Entrepreneurship nutrition. Entrepreneurship nutrition aims to foster entrepreneurial potential and skills among school members in providing healthy food at school.
Behavioral: Nutrition Education Capacity Building for Teachers and Management
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.
No Intervention: Control schools
The control group receive no specific intervention other than current school health program conducted by the local public health centers (puskesmas).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline and 6 months
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
at baseline and 6 months
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
at baseline and 6 months
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
at baseline and 6 months
Nutritional status-clinical outcome
Time Frame: at baseline and 6 months
Body Mass Index (BMI) for Age
at baseline and 6 months
mid-upper arm circumference (MUAC)
Time Frame: at baseline and 6 months
Nutritional status-clinical outcome
at baseline and 6 months
waist circumference
Time Frame: at baseline and 6 months
Nutritional status-clinical outcome
at baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
School readiness on the implementation of the program - - Descriptive, Quantitative (proportion), Qualitative
Time Frame: Baseline
Data source : School readiness questionnaire (Likert scale; validated)
Baseline
Attendance of teachers to training sessions-proportion
Time Frame: at the end of the three days training
Data source: Training attendance list
at the end of the three days training
Activity report completed-proportion
Time Frame: during the 6-month of intervention
Data source: NGTS monitoring dashboard
during the 6-month of intervention
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
during the 6-month intervention
Students' and teachers' preference and acceptance on IEC material/modules - Qualitative
Time Frame: during the 6-month intervention
Data source: FGD's guidelines
during the 6-month intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SEAMEO Regional Centre for Food and Nutrition

Collaborators

Fakultas Kedokteran Universitas Indonesia

Investigators

  • Principal Investigator: Indah S Widyahening, Professor, Seameo Recfon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESTEEM NGTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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