NCT06515288

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

July 16, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

School-based interventionobesityadolescentpreventionnutrition

Outcome Measures

Primary Outcomes (7)

  • Knowledge on healthy diet among children - clinical outcome

    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

    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

    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

    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

    Body Mass Index (BMI) for Age

    at baseline and 6 months

  • mid-upper arm circumference (MUAC)

    Nutritional status-clinical outcome

    at baseline and 6 months

  • waist circumference

    Nutritional status-clinical outcome

    at baseline and 6 months

Secondary Outcomes (5)

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

    Baseline

  • Attendance of teachers to training sessions-proportion

    at the end of the three days training

  • Activity report completed-proportion

    during the 6-month of intervention

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

    during the 6-month intervention

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

    during the 6-month intervention

Study Arms (2)

Intervention schools

EXPERIMENTAL

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 PackageBehavioral: Nutrition Education Capacity Building for Teachers and Management

Control schools

NO INTERVENTION

The control group receive no specific intervention other than current school health program conducted by the local public health centers (puskesmas).

Interventions

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.

Intervention schools

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.

Intervention schools

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • unwilling and/or unable to complete the questionnaire thoroughly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seameo Recfon

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

RECRUITING

Related Publications (17)

  • National Institute of Health Research and Development. Basic Health Research 2013. Jakarta: Ministry of Health of the Republic of Indonesia, National Institute of Health Research and Development; 2013.

    BACKGROUND
  • National Institute of Health Research and Development. Basic Health Research 2018. Jakarta: Ministry of Health of the Republic of Indonesia, National Institute of Health Research and Development; 2018.

    BACKGROUND
  • Glanz K, Lankenau B, Foerster S, Temple S, Mullis R, Schmid T. Environmental and policy approaches to cardiovascular disease prevention through nutrition: opportunities for state and local action. Health Educ Q. 1995 Nov;22(4):512-27. doi: 10.1177/109019819502200408.

    PMID: 8550374BACKGROUND
  • World Health Organization. School Policy Framework: implementation of the WHO global strategy on diet, physical activity and health. Geneva: World Health Organization; 2008.

    BACKGROUND
  • World Health Organization. Global status report of noncommunicable diseases 2014. Geneva, Switzerland: World Health Organization; 2014.

    BACKGROUND
  • Parcel GS, Simons-Morton B, O'Hara NM, Baranowski T, Wilson B. School promotion of healthful diet and physical activity: impact on learning outcomes and self-reported behavior. Health Educ Q. 1989 Summer;16(2):181-99. doi: 10.1177/109019818901600204.

    PMID: 2732062BACKGROUND
  • Silveira JA, Taddei JA, Guerra PH, Nobre MR. Effectiveness of school-based nutrition education interventions to prevent and reduce excessive weight gain in children and adolescents: a systematic review. J Pediatr (Rio J). 2011 Sep-Oct;87(5):382-92. doi: 10.2223/JPED.2123. English, Portuguese.

    PMID: 22012577BACKGROUND
  • Verrotti A, Penta L, Zenzeri L, Agostinelli S, De Feo P. Childhood obesity: prevention and strategies of intervention. A systematic review of school-based interventions in primary schools. J Endocrinol Invest. 2014 Dec;37(12):1155-64. doi: 10.1007/s40618-014-0153-y. Epub 2014 Sep 9.

    PMID: 25200996BACKGROUND
  • Black AP, D'Onise K, McDermott R, Vally H, O'Dea K. How effective are family-based and institutional nutrition interventions in improving children's diet and health? A systematic review. BMC Public Health. 2017 Oct 17;17(1):818. doi: 10.1186/s12889-017-4795-5.

    PMID: 29041899BACKGROUND
  • Aloia CR, Shockey TA, Nahar VK, Knight KB. Pertinence of the recent school-based nutrition interventions targeting fruit and vegetable consumption in the United States:a systematic review. Health Promot Perspect. 2016 Mar 31;6(1):1-9. doi: 10.15171/hpp.2016.01. eCollection 2016.

    PMID: 27123430BACKGROUND
  • Colley P, Myer B, Seabrook J, Gilliland J. The Impact of Canadian School Food Programs on Children's Nutrition and Health: A Systematic Review. Can J Diet Pract Res. 2019 Jun 1;80(2):79-86. doi: 10.3148/cjdpr-2018-037. Epub 2018 Nov 15.

    PMID: 30430855BACKGROUND
  • Kong K, Liu J, Tao Y. Limitations of studies on school-based nutrition education interventions for obesity in China: a systematic review and meta-analysis. Asia Pac J Clin Nutr. 2016;25(3):589-601. doi: 10.6133/apjcn.092015.19.

    PMID: 27440695BACKGROUND
  • Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000 Sep 16;321(7262):694-6. doi: 10.1136/bmj.321.7262.694. No abstract available.

    PMID: 10987780BACKGROUND
  • Liu Z, Wu Y, Niu WY, Feng X, Lin Y, Gao A, Zhang F, Fang H, Gao P, Li HJ, Wang H; study team for the DECIDE-children study. A school-based, multi-faceted health promotion programme to prevent obesity among children: protocol of a cluster-randomised controlled trial (the DECIDE-Children study). BMJ Open. 2019 Nov 2;9(11):e027902. doi: 10.1136/bmjopen-2018-027902.

    PMID: 31678935BACKGROUND
  • Octaria Y, Apriningsih A, Dwiriani CM, Februhartanty J. School readiness to adopt a school-based adolescent nutrition intervention in urban Indonesia. Public Health Nutr. 2021 Jun;24(S2):s72-s83. doi: 10.1017/S1368980020001299. Epub 2020 May 7.

    PMID: 32375906BACKGROUND
  • Maehara M, Rah JH, Roshita A, Suryantan J, Rachmadewi A, Izwardy D. Patterns and risk factors of double burden of malnutrition among adolescent girls and boys in Indonesia. PLoS One. 2019 Aug 20;14(8):e0221273. doi: 10.1371/journal.pone.0221273. eCollection 2019.

    PMID: 31430324BACKGROUND
  • Topolski TD, LoGerfo J, Patrick DL, Williams B, Walwick J, Patrick MB. The Rapid Assessment of Physical Activity (RAPA) among older adults. Prev Chronic Dis. 2006 Oct;3(4):A118. Epub 2006 Sep 15.

    PMID: 16978493BACKGROUND

Related Links

MeSH Terms

Conditions

Pediatric ObesityObesity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Indah S Widyahening, Professor

    SEAMEO RECFON

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Indah S Widyahening, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Five intervention schools and five control schools will be selected from five different municipalities in Jakarta, with each school having a minimum of 100 students (grade 10-11; 15-17 years old). 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. 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 23, 2024

Study Start

January 9, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations