Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000863235
Ethics application status
Approved
Date submitted
3/04/2018
Date registered
22/05/2018
Date last updated
22/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of Metabolic Syndrome Among teachers in Makassar, Indonesia : School based
Scientific title
Impact of Balanced Nutrition Education on Prevention Metabolic Syndrome Among teachers in Makassar, Indonesia : School based
Secondary ID [1] 294483 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 307245 0
Obesity 307247 0
Condition category
Condition code
Public Health 306364 306364 0 0
Health promotion/education
Diet and Nutrition 306365 306365 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an intervention related to the knowledge, attitudes and practice of balanced nutrition guidelines done to teachers in schools for 4 months. Intervention is done by using modules and educational tools that have been developed using the concept of Self determination theory and based on preliminary study results that have been done previously. Balanced nutrition guidelines are guidelines issued by health ministries to prevent the increasing prevalence of non-communicable diseases, including the metabolic syndrome. The guidelines for balanced nutrition consist of 10 basic messages: eating a variety of foods; eating lots of vegetables and enough fruits; eat food high in protein; getting used to a variety of staple foods; limiting consumption of sweet, salty and fatty foods; getting breakfast; get used to drink enough water and safe; get used to read labels on the packaging; wash hands with clean water; and do physical activity and maintain ideal body weight.
Activities are conducted in the school each month with a related theme
1. Know the health problems and consumption of vegetables and fruits
2. Physical activity, sedentary behavior and maintaining ideal body weight
3. Eat high protein side dishes, limit the consumption of sweet, salty and fatty foods, and get used to reading the label on the packaging
4. Breakfast and drink enough water.

Instruments provided are balanced nutrition module, balance sheet (calendar) balanced nutrition, Poster physical activity.

The meeting will be conducted by 4 facilitators, The facilitator has been trained before, and has experience in providing education to several population groups such as students, teachers, and company employees.

Face-to-face meetings are conducted in each school by collecting all the teachers each month

Each meeting will end with an evaluation that each respondent should fill in on the behavior performed within 1 month, related to the material that has been given previously.

Frequency of meeting 1 x 45 minutes per month for 4 month (Timing based FGD conducted before in other school in Makassar)
Modules and educational tools have been developed by using our preliminary study and FGD from teacher. Modules adapt from some modules, including:
• Perth Active Living for Seniors (PALS) Program “Improving quality of life through physical activity and nutrition” a project of the western Australian centre for health promotion research, curtin university, the national heart foundation of Australia (WA Division) in collaboration with the Australian Technology Network Universities Centre for Metabolic Fitness (Burke et al., 2008).
• Balance nutrition module for elementary children. Module of Cooperation from Center for nutrition and health studies And Center For Health Research. Public Health Faculty. Universitas Indonesia 2011. (Puska, FKM, & UI, 2011).
• Food chemistry learning module for healthy eating behavior (Based on Cognitive Social theory (Husain, 2016).


In school we conducted a group discussion

For the control group we use pamphlet balance nutrition guidelines reprint with permission from the Ministry of Health Indonesia

We have also conducted FGDs on teachers at other schools in Makassar city with the following objectives:

a. Explores the obstacles of teachers in practicing balanced nutrition guidelines
b. Assess the modules and educational tools that have been prepared
c. Determine the length of time that can be used, when meeting with the teacher.

For evaluation, we make a checklist of balanced nutrition practices that have been done by the respondent at the end of each module. This checklist is filled out every week and will be collected at the next meeting. Cheklist will be moved to another sheet, so the module remains complete.
Intervention code [1] 300778 0
Behaviour
Intervention code [2] 300779 0
Prevention
Comparator / control treatment
The control group will be given a balanced nutrition guidelines pamphlet that has been issued by the health ministry. Pamphlet will be given 1 time in a meeting with all teachers who become control in one school.
Control group
Active

Outcomes
Primary outcome [1] 305377 0
Fasting blood glucose was analysis by hexokinase.
Timepoint [1] 305377 0
Baseline

4 month post completion of the intervention program (primary endpoint)

9 month after intervention
Primary outcome [2] 305904 0
Waist Circumference was measured by using OneMed Tape measure. Waist circumference will be measured standing up at the level midway between the lowest rib margin and the iliac crest to the nearest 0.5 cm
Timepoint [2] 305904 0
Baseline
4 month post completion of the intervention program (primary endpoint)
9 month after intervention
Primary outcome [3] 305905 0
Lipid profile (HDL was analysis by using homogeneous enzymatic colorimetric assay method and triglycerides was analysis by using enzymatic colorimetric method)
Timepoint [3] 305905 0
Baseline

4 month post completion of the intervention program (primary endpoint)

9 month after intervention
Secondary outcome [1] 344995 0
Changes in physical activity assed by IPAQ
Timepoint [1] 344995 0
Baseline, 4 month post completion of the intervention program, 9 month after intervention
Secondary outcome [2] 344996 0
Changes in sitting time assed by IPAQ
Timepoint [2] 344996 0
Baseline, 4 month post completion of the intervention program, 9 month after intervention
Secondary outcome [3] 346499 0
Changes in Knowledge assed by Knowledge, attitude and practice (KAP) questionnaire have been validated before with R =0,790
Timepoint [3] 346499 0
Baseline,
4 month post completion of the intervention program
9 month after intervention
Secondary outcome [4] 346500 0
Changes in attitudes assed by Knowledge, attitude and practice (KAP) questionnaire have been validated before with R =0,737
Timepoint [4] 346500 0
Baseline,
4 month post completion of the intervention program
9 month after intervention
Secondary outcome [5] 346501 0
Changes in Practice assed by Knowledge, attitude and practice (KAP) questionnaire have been validated before with R =0,769
Timepoint [5] 346501 0
Baseline,
4 month post completion of the intervention program
9 month after intervention
Secondary outcome [6] 346502 0
Changes in Autonomous, competence and relatedness measured by TSRQ (treatment self regulation questionnaire)
Timepoint [6] 346502 0
Baseline,
4 month post completion of the intervention program
9 month after intervention
Secondary outcome [7] 346974 0
Blood Pressure was measured by using Riester mercury sphygmomanometer
Timepoint [7] 346974 0
Baseline,
4 month post completion of the intervention program
9 month after intervention

Eligibility
Key inclusion criteria
civil servant
Willing to participate for 3 years
Minimum age
25 Years
Maximum age
57 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Has been diagnosed diabetes, heart disease, stroke and cancer by doctors
Will retire in 3 years
Pregnant women

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We hypothesise effect of our intervention 10% increase compared with controls. Power of beta 90%, significance level of 0.05 and standard deviation from other study 16, we calculate 54 respondent to each group. Total minimal sample for this study 108 respondent.

Comparisons between the changes (metabolic syndrome paramaters; knowledge, attitude and practice about balance nutrition guidelines; physical activity; sitting time; dietary pattern; stress level; sleep pattern; spiritual level for moslem respondent) in intervention group and the control group will be performed using univariate and multivariable statistical methods. Outcome variables at baseline and post-intervention will be used to test the hypotheses in association with the covariates and confounding demographic and lifestyle variables. Continuous and categorical outcomes will be analysed using 2-part generalised linear mixed regression models, accounting for the correlations between repeated measures and clustering of the data.

SEM Analysis will use to describe relation between Self determination concept (Autonomous, competence and relatedness) using Treatment self regulation questionnaire (TSRQ) and change of practice balance nutrition guidelines.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
30/10/2017
Date of last participant enrolment
Anticipated
Actual
25/11/2017
Date of last data collection
Anticipated
12/04/2019
Actual
Sample size
Target
108
Accrual to date
Final
108
Recruitment outside Australia
Country [1] 10249 0
Indonesia
State/province [1] 10249 0
Makassar/South Sulawesi

Funding & Sponsors
Funding source category [1] 299109 0
Government body
Name [1] 299109 0
Ministry of research, technology, and higher education
Country [1] 299109 0
Indonesia
Primary sponsor type
Government body
Name
Ministry of research, technology, and higher education
Address
Ministry of research, technology, and Higher Education
Second Building BPPT (Badan Pengkajian dan Penerapan Teknologi) MH Thamrin Street
Central Jakarta
Jakarta 10340
Country
Indonesia
Secondary sponsor category [1] 298364 0
University
Name [1] 298364 0
Hasanuddin University
Address [1] 298364 0
Perintis Kemerdekaan Street Km 10. Post code 90245 Makassar, South Sulawesi, Indonesia
Country [1] 298364 0
Indonesia
Secondary sponsor category [2] 298367 0
University
Name [2] 298367 0
Public Health Faculty Hasanuddin University
Address [2] 298367 0
Perintis Kemerdekaan Street Km 10. Post code 90245 Makassar, South Sulawesi, Indonesia
Country [2] 298367 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300041 0
Faculty of Medicine Hasanuddin University
Ethics committee address [1] 300041 0
Perintis Kemerdekaan street Km. 10 post code 90245
3rd floor of an integrated laboratory building
Faculty of Medicine - Hasanuddin University
Makassar – South Sulawesi
Indonesia
Ethics committee country [1] 300041 0
Indonesia
Date submitted for ethics approval [1] 300041 0
09/10/2017
Approval date [1] 300041 0
25/10/2017
Ethics approval number [1] 300041 0
UH17080550

Summary
Brief summary
Metabolic syndrome (Mets) is a metabolic disorder that can increase the risk of non-communicable diseases, including heart disease, stroke and type 2 diabetes. Mets prevalence in various countries in the world is high, including in Indonesia. Nutrition education is one of the efforts to control health problems. Giving education in groups gives a positive impact on the efforts of controlling type 2 diabetes as well
metabolic disorders. Implementation of Self Determination Theory concept
(SDT) in nutrition education gives positive results and long-term adoption. This is done by giving
education, counseling and support so that behavioral changes that occur based on his own desires.
This study will going for 3 years consisting of module preparation, interventional change of balanced nutrition behavior in 4 months, follow-up without intervention in 9 months among high school teachers in Makassar City. Provision of balanced nutrition education interventions includes meetings
4 times in each school, giving physical activity poster 1 time, giving calendar with balanced nutrition guideline picture 1 times. While the control group was given a balanced nutrition pamphlet from the Indonesian Ministry of Health.
Each intervention carried out incorporates the concept of SDT so that it can be adopted for long term.
The results of this study is a balanced nutrition education module with the concept of SDT.
Nutrition education with the concept of SDT in teachers, will provide long-term adopted behavioral changes, and teachers will provide examples of balanced nutritional behavior for students.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2565 2565 0 0
/AnzctrAttachments/374826-Ethics.pdf (Ethics approval)

Contacts
Principal investigator
Name 82362 0
Dr Dr. Nurhaedar Jafar, Apt, M.Kes
Address 82362 0
Hasanuddin University
Perintis Kemerdekaan Street Km. 10 90245

Makassar-South Sulawesi
Country 82362 0
Indonesia
Phone 82362 0
+6281342768385
Fax 82362 0
Email 82362 0
[email protected]
Contact person for public queries
Name 82363 0
Nurzakiah Hasan
Address 82363 0
Hasanuddin University
Perintis Kemerdekaan Street Km. 10 90245

Makassar-South Sulawesi
Country 82363 0
Indonesia
Phone 82363 0
+6281342226001
Fax 82363 0
Email 82363 0
[email protected]
Contact person for scientific queries
Name 82364 0
Prof. Veni Hadju
Address 82364 0
Hasanuddin University
Perintis Kemerdekaan Street Km. 10 90245

Makassar-South Sulawesi
Country 82364 0
Indonesia
Phone 82364 0
+62811441803
Fax 82364 0
Email 82364 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.