Lingkar Sehat Banyuwangi (Banyuwangi Healthy Circle): a school, retailer, and government partnership model for healthy consumption among adolescents in Banyuwangi District, Indonesia

ISRCTN ISRCTN14131034
DOI https://doi.org/10.1186/ISRCTN14131034
Secondary identifying numbers PRJ 61/LPDP/2021
Submission date
07/02/2022
Registration date
16/02/2022
Last edited
29/07/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The number of smokers and obese among adolescents in Indonesia continues to increase. Smoking and obesity are linked to unhealthy choices that adolescents make that are affected by what products are available, affordable and advertised around them. This study aims to recruit a total of 500 students and 300 retailers around schools to test whether Banyuwangi Healthy Circle, a Healthy Trading Model Around Schools can reduce unhealthy consumption among adolescents in Banyuwangi Subdistrict.

Who can participate?
Students in grades 4, 5, 7 and 8 of participating schools can participate. Retailers that sell food, drinks or cigarettes within 250 m of the participating schools can participate in this study

What does the study involve?
Students and retailers are distributed into schools that apply the Banyuwangi Healthy Circle Model and schools without the model. Students in the schools with Banyuwangi Healthy Circle Model will be trained to make healthy choices and encouraged to shop at Healthy Vendors as well as to watch whether Healthy Vendors practice healthy trade. Retailers around schools with Banyuwangi Healthy Model will be trained to practice healthy trading with adolescents. Healthy trading includes hiding cigarettes from sight, refusing unhealthy product instore advertisements, refusing to sell cigarette to adolescents, increasing the number of healthy choices, offering healthier alternatives to adolescents and giving health advice to adolescent customers. Healthy vendors will receive a certified label from District Health Office and a banner with a Healthy Vendor sign. Healthy Vendors will also be promoted to students by schools and government offices.
Students and retailers around schools without the model will run as usual.

What are the possible benefits and risks of participating?
Participation in Banyuwangi Health Circle will provide participants with some useful information about healthy consumption and will help them to practice a healthy lifestyle and healthy trading. The study is low risk and there will be no adverse effects associated with participation. Participants will be informed about the study and are able to leave the study at any time

Where is the study run from?
Research Group for Health and Wellbeing of Women and Children of the Faculty of Public Health Universitas Airlangga in Banyuwangi is running the study (Indonesia)

When is the study starting and how long is it expected to run for?
March 2021 to June 2023

Who is funding the study?
Lembaga Pengelola Dana Pendidikan (LPDP) (Indonesia)

Who is the main contact?
Dr Susy K. Sebayang
sksebayang@fkm.unair.ac.id

Contact information

Dr Susy Sebayang
Principal Investigator

Jl. Ikan Wijinongko No 18, Sobo
Banyuwangi
68418
Indonesia

ORCiD logoORCID ID 0000-0003-0470-8308
Phone +62 81288283367
Email sksebayang@fkm.unair.ac.id

Study information

Study designSingle center interventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleThe impact of Lingkar Sehat Banyuwangi (Banyuwangi Healthy Circle) as a healthy trading model around schools to reduce unhealthy consumption among adolescents in Banyuwangi District, Indonesia
Study objectives1. Lingkar Sehat Banyuwangi (Banyuwangi Healthy Circle) reduces unhealthy food intakes among adolescents
2. Lingkar Sehat Banyuwangi (Banyuwangi Healthy Circle) reduces intention to smoke among adolescents
3. Lingkar Sehat Banyuwangi (Banyuwangi Healthy Circle) improves knowledge of healthy consumptions among adolescents
4. Lingkar Sehat Banyuwangi (Banyuwangi Healthy Circle) improves knowledge of healthy trading among retailers
Ethics approval(s)Approved 11/06/2021, Health Research Ethics Committee (Faculty Of Public Health, Universitas Airlangga, Mulyorejo, Surabaya, East Java 60115, Indonesia; +628165402532 ; adm.kepk@fkm.unair.ac.id), ref: 10/EA/KEPK/2021
Health condition(s) or problem(s) studiedPrevention of smoking and unhealthy diets in adolescents
InterventionCurrent intervention as of 21/03/2022:
A total of 10 Adiwiyata schools in Banyuwangi and Giri Subdistrict will be randomly selected to the intervention group and a total of 10 Adiwiyata schools in Genteng and Rogojampi Subdistrict will be randomly selected to the control group. Randomization is done in Stata from a list of eligible students and retailers. Adiwiyata schools are schools that are acknowledged by the local, provincial and or national government as having good management for a healthy school environment.

Each school in the intervention group will receive a package of intervention which include the following:
1. Randomly selected students grade 4, 5, 7 and 8 will be selected to receive:
a. a training on healthy consumption choice
b. Information and reminders about Warung Sehat (Healthy Vendors) around schools
c. A training on monitoring and evaluation of Healthy Vendors
2. All school cafeterias and randomly selected retailers within 250 m outside of school will be trained to be Healthy Vendors (Warung Sehat). A Healthy Vendor will be required to:
A. Refuse placement of unhealthy advertisement from cigarette and or food companies
B. Hide unhealthy products especially cigarettes
C. Increase the number of healthy choices
D. Offer healthy products to adolescent customers
E. Offer healthier alternatives if adolescents request for unhealthy products
F. Reject selling cigarettes to adolescents
G. Give health advice including hand washing, no smoking, healthy and nutritious diets)
3. Each participating Healthy Vendor will receive:
a. A label certified by District Health Office and a banner with Healthy Vendor (Warung Sehat) sign
b. Warung Sehat promotion by participating schools and by District Health Office, District Education Office and District Cooperatives, Micro enterprise and Trade Office through their public communication channel and social media

Intervention is followed up until 6 months

Students will be selected from a list of students at grade 4, 5, 7 and 8 in each school. A total of 250 students in each arm will be selected randomly using Proportion to Population size method. A total of 100 of the 250 students in the intervention group will be selected to receive training on monitoring and evaluation of the Healthy Vendors' compliance.

All cafeterias in participating schools will be recruited to participate. Retailers outside of schools will be randomly selected to participate from a list of retailers that sell either food, drinks, or cigarettes within 250 m of schools. Either the owner or a keeper of the vendor will be asked to participate.

_____


Previous intervention as of 04/03/2022:
A total of 10 Adiwiyata schools in Banyuwangi and Giri Subdistrict will be randomly selected to the intervention group and a total of 10 Adiwiyata schools in Genteng and Rogojampi Subdistrict will be randomly selected to the control group. Randomization will be done in excel spreadsheets from a list of eligible students and retailers. Adiwiyata schools are schools that are acknowledged by the local, provincial and or national government as having good management for a healthy school environment.

Each school in the intervention group will receive a package of intervention which include the following:
1. Randomly selected students grade 4, 5, 7 and 8 will be selected to receive:
a. a training on healthy consumption choice
b. Information and reminders about Warung Sehat (Healthy Vendors) around schools
c. A training on monitoring and evaluation of Healthy Vendors
2. All school cafeterias and randomly selected retailers within 250 m outside of school will be trained to be Healthy Vendors (Warung Sehat). A Healthy Vendor will be required to:
A. Refuse placement of unhealthy advertisement from cigarette and or food companies
B. Hide unhealthy products especially cigarettes
C. Increase the number of healthy choices
D. Offer healthy products to adolescent customers
E. Offer healthier alternatives if adolescents request for unhealthy products
F. Reject selling cigarettes to adolescents
G. Give health advice including hand washing, no smoking, healthy and nutritious diets)
3. Each participating Healthy Vendor will receive:
a. A label certified by District Health Office and a banner with Healthy Vendor (Warung Sehat) sign
b. Warung Sehat promotion by participating schools and by District Health Office, District Education Office and District Cooperatives, Micro enterprise and Trade Office through their public communication channel and social media

Intervention is followed up until 6 months

Students will be selected from a list of students at grade 4, 5, 7 and 8 in each school. A total of 250 students in each arm will be selected randomly using Proportion to Population size method. A total of 100 of the 250 students in the intervention group will be selected to receive training on monitoring and evaluation of the Healthy Vendors' compliance.

All cafeterias in participating schools will be recruited to participate. Retailers outside of schools will be randomly selected to participate from a list of retailers that sell either food, drinks, or cigarettes within 250 m of schools. Either the owner or a keeper of the vendor will be asked to participate.

_____

Previous intervention:
A total of 10 Adiwiyata schools in Banyuwangi and Giri Subdistrict will be randomly selected to the intervention group and a total of 10 Adiwiyata schools in Genteng and Rogojampi Subdistrict will be randomly selected to the control group. Randomization will be done in excel spreadsheets from a list of eligible students and retailers. Adiwiyata schools are schools that are acknowledged by the local, provincial and or national government as having good management for a healthy school environment.

Each school in the intervention group will receive a package of intervention which include the following:
1. Randomly selected students grade 4, 5, 7 and 8 will be selected to receive:
a. a training on healthy consumption choice
b. Information and reminders about Warung Sehat (Healthy Vendors) around schools
c. A training on monitoring and evaluation of Healthy Vendors
2. Randomly selected retailers within 250 m of school (including school cafeteria) will be trained to be Healthy Vendors (Warung Sehat). A Healthy vendor will be required to:
A. Refuse placement of unhealthy advertisement from cigarette and or food companies
B. Hide unhealthy products especially cigarettes
C. Increase the number of healthy choices
D. Offer healthy products to adolescent customers
E. Offer healthier alternatives if adolescents request for unhealthy products
F. Reject selling cigarettes to adolescents
G. Give health advice including hand washing, no smoking, healthy and nutritious diets)
3. Each participating Healthy Vendor will receive:
a. A label certified by District Health Office and a banner with Healthy Vendor (Warung Sehat) sign
b. Warung Sehat promotion by participating schools and by District Health Office, District Education Office and District Cooperatives, Micro enterprise and Trade Office through their public communication channel and social media

Intervention is followed up until 6 months

Students will be selected from a list of students at grade 4, 5, 7 and 8 in each school. A total of 250 students in each arm will be selected randomly using Proportion to Population size method. A total of 100 of the 250 students in the intervention group will be selected to be receive a training on monitoring and evaluation of the Healthy Vendors' compliance.

Retailers will be randomly selected to participate from a list of retailers that sell either food, drinks or cigarettes within 250 m of schools (including school cafeteria). Either the owner or a keeper of the vendor will be asked to participate.
Intervention typeBehavioural
Primary outcome measure1. Intention to smoke next year will be measured using a questionnaire to students at baseline, 2 months and after 6 months after intervention
2. Sugar sweetened beverage, salt and fat intake will be measured using food frequency questionnaire to students at baseline, 2 months and 6 months after intervention
3. Student’s knowledge of healthy consumption will be measured using a battery of questions regarding healthy consumption at baseline, after training, 2 months and 6 months after intervention
4. Improvement in retailers’ knowledge of healthy trading will be measured using a battery of questions regarding healthy trading at baseline, after training, 2 months and 6 months after intervention
Secondary outcome measures1. Adolescents’ expenditure on unhealthy food purchased will be measured using a food frequency questionnaire at baseline, 2 months after training, and 6 months of intervention
2. Smoking prevalence will be measured using a questionnaire to students at baseline, 2 months, and after 6 months of intervention
3. BMI (kg/m²) for age will be measured at baseline, 2 months, and 6 months of intervention
Overall study start date01/03/2021
Completion date30/06/2023

Eligibility

Participant type(s)Other
Age groupMixed
SexBoth
Target number of participantsTen schools in each arm will be included in the study. In each school students and owner/keeper of vendors around schools will be randomly selected to participate. A total of 250 students in each arm and 150 retailers in each arm will be recruited.
Total final enrolment729
Key inclusion criteria1. Students: grade 4, 5, 7 and 8 of the randomly selected Adiwiyata schools
2. Retailers: retailers’ owners or keepers who sell either food, drinks or cigarettes within 250 m radius of the selected Adiwiyata schools
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment05/03/2022
Date of final enrolment29/06/2022

Locations

Countries of recruitment

  • Indonesia

Study participating centre

Research Group for Health and Wellbeing of Women and Children, Faculty of Public Health, Universitas Airlangga
Jl. Ikan Wijinongko No 18, Sobo
Banyuwangi
68418
Indonesia

Sponsor information

Universitas Airlangga
University/education

Badan Pengembangan Bisnis Rintisan dan Inkubasi
Jl. Airlangga No 4-6, Gubeng
Surabaya
60115
Indonesia

Phone +62 31 5912546
Email info@bpbrin.unair.ac.id
Website https://bpbrin.unair.ac.id

Funders

Funder type

Government

Lembaga Pengelola Dana Pendidikan (LPDP)

No information available

Results and Publications

Intention to publish date30/06/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planData sharing statement to be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 29/07/2024 Yes No

Additional files

ISRCTN14131034 Basic Summary Results ISRCTN.pdf

Editorial Notes

29/07/2024: The basic results have been uploaded as an additional file.
30/06/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2022 to 29/06/2022.
2. The total final enrolment number has been added.
13/05/2022: The recruitment end date has been changed from 07/05/2022 to 30/06/2022.
21/03/2022: The following changes have been made:
1. The recruitment start date has been changed from 07/03/2022 to 05/03/2022.
2. The intervention has been changed.
04/03/2022: The intervention has been updated.
15/02/2022: Trial's existence confirmed by Lembaga Pengelola Dana Pendidikan (LPDP)