NCT06601348

Brief Summary

The prevalence of obesity in children is increasing rapidly, Among children aged 5-12 years, 18.8% have severe overweight, comprising 10.8% who are obese and 8.8% who are over. The development of effective and sustainable intervention strategies to prevent childhood obesity in Indonesia is becoming increasingly important, particularly given the limited implementation of health-promoting schools in the country. The first Phase using qualitative exploration was a needs assessment will be using of social cognitive theory. The second Phase will be the development model intervention modification of the health promotion school WHO and "Health School". The third Phase is the quantitative stage using a Cluster Randomised Controlled Trial to analyse differences and test the effectiveness of the HPS model. This study will be conducted in 8 primary schools located in Makassar, South Sulawesi. School in Makassar city and schools from outside Makassar city, randomly selected for the trial. Then the selected schools are randomly divided into school for nutrition education and physical activity. Intervention, while school each for comprehensive intervention. The study will be target students in Grades 4 and 5 of primary school. Assessments for the primary objective (BMI Z score), and secondary objectives (change in knowledge, self-efficacy, and health literacy) in thirds study arm. The subsequent phase will assess the efficacy of the intervention in terms of reductions in BMI Z scores, improvements in knowledge, self-efficacy and health literacy. Concurrently, the exploration of parental and teacher knowledge and insights regarding health promotion in schools and its potential in reducing overweight and obesity in children will be conducted.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet 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

First Submitted

Initial submission to the registry

September 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

October 4, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

September 6, 2024

Last Update Submit

September 13, 2024

Conditions

Keywords

Childhood overweight and obesity, health promoting schools, Nutrition Education, Physical activity

Outcome Measures

Primary Outcomes (1)

  • BMI Z-score

    Where weight will be measured using a body composition meter (Seca 804) to 0.1 kg, and height measured with a stadiometer to 0.1 cm. BMI (kg/m2) will be converted to the Weight and height measurements will be taken twice to obtain accuracy and correct averages. Body mass index (BMI) for age Z score, according in 2007 WHO Growth Standards for children, will be used to classify the risk of being overweight with a Z SD score of 1, overweight with a Z SD score 1, and overweight: BMI Z-score ≤ 3, obesity BMI Z- score ≥ 3.

    6 months intervention combining health promoting school

Secondary Outcomes (1)

  • Children knowledge, Self-efficacy, and Health Literacy

    3 months trial, 3 months implementation of health promoting school (HPS) model

Study Arms (1)

Nutrition education, physical activity interventions, and a health promoting school

OTHER

The intervention programme will be implemented for 6 months. Nutrition education is developed through piloting a health promoting school model, the content will combine the government programme "healthy school" and WHO cartoon pamphlets distributed to each school/student in the intervention school. Nutrition and health education was provided 6 times for students, and 2 times for parents and 4 times for teachers and UKS officers. Physical activity intervention School-based physical activity programme for students called "Happy in school children" Other forms of physical activity included games, dance or rhythmic gymnastics, such as jumping rope, and squatting, or by adjusting the curriculum. And piloting the health promoting school (HPS) model, the expected outcome of the health promoting school (HPS) model is health literacy.

Other: Nutrition education, physical activity intervention, and health promoting school model trials

Interventions

A nutrition education and physical activity intervention, combining a pilot health promoting school model that includes health education and recreational enhancement with the curriculum of a government-designated healthy school, was designed to reduce childhood overweight and obesity. The programme was implemented over 6 months. This program has been widely conducted in several countries, but there are still many differences from previous studies, especially in terms of strengthening qualitative studies in the first stage, then in the intervention stage using a Cluster Randomised Controlled Trial design. Another advantage of this study is the combination of intervention and health promoting school. In Indonesia, there are few intervention studies in reducing overweight and obesity in children, some only focus on descriptive studies such as nutritional knowledge, physical activity measures using questionnaires to determine the relationship or measure BMI.

Nutrition education, physical activity interventions, and a health promoting school

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female gender
  • Children aged 9-12 years old (at the time of baseline data collection)
  • All fourth and fifth grade students/children
  • Children who are willing as respondents and ready to follow the intervention until completion and willing to fill in the informed consent.
  • Withdrawal: Children experiencing physical and mental health conditions during the intervention (arising due to the child\'s own health conditions, not due to the effects of the intervention)
  • Full day children

You may not qualify if:

  • Children with clinical conditions / health disorders such as heart disease etc.)
  • Children who did not take the pretest
  • Children who left or moved schools
  • Children who did not complete the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elementary School Al-Azhar

Makassar, South Sulawesi, 90222, Indonesia

Location

Elementary School Tete Batu and Sudirman

Makassar, South Sulawesi, 90222, Indonesia

Location

Related Publications (6)

  • Wang Z, Xu F, Ye Q, Tse LA, Xue H, Tan Z, Leslie E, Owen N, Wang Y. Childhood obesity prevention through a community-based cluster randomized controlled physical activity intervention among schools in china: the health legacy project of the 2nd world summer youth olympic Games (YOG-Obesity study). Int J Obes (Lond). 2018 Apr;42(4):625-633. doi: 10.1038/ijo.2017.243. Epub 2017 Oct 5.

    PMID: 28978975BACKGROUND
  • Pluimakers VG, van Atteveld JE, de Winter DTC, Bolier M, Fiocco M, Nievelstein RJAJ, Janssens GOR, Bresters D, van der Heiden-van der Loo M, de Vries ACH, Louwerens M, van der Pal HJ, Pluijm SMF, Ronckers CM, Versluijs AB, Kremer LCM, Loonen JJ, van Dulmen-den Broeder E, Tissing WJE, van Santen HM, van den Heuvel-Eibrink MM, Neggers SJCMM. Prevalence, risk factors, and optimal way to determine overweight, obesity, and morbid obesity in the first Dutch cohort of 2338 long-term survivors of childhood cancer: a DCCSS-LATER study. Eur J Endocrinol. 2023 Nov 8;189(5):495-507. doi: 10.1093/ejendo/lvad139.

    PMID: 37837608BACKGROUND
  • Lee J, Hoornbeek J, Oh N. Social Cognitive Orientations, Social Support, and Physical Activity among at-Risk Urban Children: Insights from a Structural Equation Model. Int J Environ Res Public Health. 2020 Sep 16;17(18):6745. doi: 10.3390/ijerph17186745.

    PMID: 32947944BACKGROUND
  • Caballero B, Clay T, Davis SM, Ethelbah B, Rock BH, Lohman T, Norman J, Story M, Stone EJ, Stephenson L, Stevens J; Pathways Study Research Group. Pathways: a school-based, randomized controlled trial for the prevention of obesity in American Indian schoolchildren. Am J Clin Nutr. 2003 Nov;78(5):1030-8. doi: 10.1093/ajcn/78.5.1030.

    PMID: 14594792BACKGROUND
  • Almutairi N, Burns S, Portsmouth L. Barriers and enablers to the implementation of school-based obesity prevention strategies in Jeddah, KSA. Int J Qual Stud Health Well-being. 2022 Dec;17(1):2135197. doi: 10.1080/17482631.2022.2135197.

    PMID: 36263729BACKGROUND
  • Bartelink NHM, van Assema P, Kremers SPJ, Savelberg HHCM, Oosterhoff M, Willeboordse M, van Schayck OCP, Winkens B, Jansen MWJ. Can the Healthy Primary School of the Future offer perspective in the ongoing obesity epidemic in young children? A Dutch quasi-experimental study. BMJ Open. 2019 Oct 31;9(10):e030676. doi: 10.1136/bmjopen-2019-030676.

    PMID: 31676651BACKGROUND

Related Links

MeSH Terms

Conditions

OverweightPediatric ObesityObesityMotor Activity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Toto Sudargo, Ph.D

    Gadjah Mada University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effectiveness Of A School-Based Nutrition Education And Physical Activity Intervention For Overweight And Obese Children: The Health Promoting School (Hps) Model

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

October 4, 2024

Primary Completion

May 18, 2025

Study Completion

June 28, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations