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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
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Scientific title
Impact of Balanced Nutrition Education on Prevention Metabolic Syndrome Among teachers in Makassar, Indonesia : School based
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Secondary ID [1]
294483
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome
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Obesity
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Condition category
Condition code
Public Health
306364
306364
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0
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Health promotion/education
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Diet and Nutrition
306365
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
300778
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Behaviour
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Intervention code [2]
300779
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Fasting blood glucose was analysis by hexokinase.
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Assessment method [1]
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Timepoint [1]
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Baseline
4 month post completion of the intervention program (primary endpoint)
9 month after intervention
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Primary outcome [2]
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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
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Assessment method [2]
305904
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Timepoint [2]
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Baseline
4 month post completion of the intervention program (primary endpoint)
9 month after intervention
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Primary outcome [3]
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Lipid profile (HDL was analysis by using homogeneous enzymatic colorimetric assay method and triglycerides was analysis by using enzymatic colorimetric method)
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Assessment method [3]
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Timepoint [3]
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Baseline
4 month post completion of the intervention program (primary endpoint)
9 month after intervention
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Secondary outcome [1]
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Changes in physical activity assed by IPAQ
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Assessment method [1]
344995
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Timepoint [1]
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Baseline, 4 month post completion of the intervention program, 9 month after intervention
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Secondary outcome [2]
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Changes in sitting time assed by IPAQ
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Assessment method [2]
344996
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Timepoint [2]
344996
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Baseline, 4 month post completion of the intervention program, 9 month after intervention
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Secondary outcome [3]
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Changes in Knowledge assed by Knowledge, attitude and practice (KAP) questionnaire have been validated before with R =0,790
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Assessment method [3]
346499
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Timepoint [3]
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Baseline,
4 month post completion of the intervention program
9 month after intervention
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Secondary outcome [4]
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Changes in attitudes assed by Knowledge, attitude and practice (KAP) questionnaire have been validated before with R =0,737
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Assessment method [4]
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Timepoint [4]
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Baseline,
4 month post completion of the intervention program
9 month after intervention
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Secondary outcome [5]
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Changes in Practice assed by Knowledge, attitude and practice (KAP) questionnaire have been validated before with R =0,769
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Assessment method [5]
346501
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Timepoint [5]
346501
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Baseline,
4 month post completion of the intervention program
9 month after intervention
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Secondary outcome [6]
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Changes in Autonomous, competence and relatedness measured by TSRQ (treatment self regulation questionnaire)
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Assessment method [6]
346502
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Timepoint [6]
346502
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Baseline,
4 month post completion of the intervention program
9 month after intervention
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Secondary outcome [7]
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Blood Pressure was measured by using Riester mercury sphygmomanometer
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Assessment method [7]
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Timepoint [7]
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Baseline,
4 month post completion of the intervention program
9 month after intervention
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Eligibility
Key inclusion criteria
civil servant
Willing to participate for 3 years
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Minimum age
25
Years
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Maximum age
57
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Has been diagnosed diabetes, heart disease, stroke and cancer by doctors
Will retire in 3 years
Pregnant women
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
30/10/2017
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Date of last participant enrolment
Anticipated
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Actual
25/11/2017
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Date of last data collection
Anticipated
12/04/2019
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Actual
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Sample size
Target
108
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Accrual to date
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Final
108
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Recruitment outside Australia
Country [1]
10249
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Indonesia
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State/province [1]
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Makassar/South Sulawesi
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Ministry of research, technology, and higher education
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Address [1]
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Ministry of research, technology, and Higher Education
Second Building BPPT (Badan Pengkajian dan Penerapan Teknologi) MH Thamrin Street
Central Jakarta
Jakarta 10340
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Country [1]
299109
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Indonesia
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Primary sponsor type
Government body
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Name
Ministry of research, technology, and higher education
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Address
Ministry of research, technology, and Higher Education
Second Building BPPT (Badan Pengkajian dan Penerapan Teknologi) MH Thamrin Street
Central Jakarta
Jakarta 10340
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Country
Indonesia
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Secondary sponsor category [1]
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University
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Name [1]
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Hasanuddin University
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Address [1]
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Perintis Kemerdekaan Street Km 10. Post code 90245 Makassar, South Sulawesi, Indonesia
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Country [1]
298364
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Indonesia
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Secondary sponsor category [2]
298367
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University
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Name [2]
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Public Health Faculty Hasanuddin University
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Address [2]
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Perintis Kemerdekaan Street Km 10. Post code 90245 Makassar, South Sulawesi, Indonesia
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Country [2]
298367
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Indonesia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Faculty of Medicine Hasanuddin University
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Ethics committee address [1]
300041
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Perintis Kemerdekaan street Km. 10 post code 90245 3rd floor of an integrated laboratory building Faculty of Medicine - Hasanuddin University Makassar – South Sulawesi Indonesia
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Ethics committee country [1]
300041
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Indonesia
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Date submitted for ethics approval [1]
300041
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09/10/2017
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Approval date [1]
300041
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25/10/2017
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Ethics approval number [1]
300041
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UH17080550
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
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/AnzctrAttachments/374826-Ethics.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
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Dr Dr. Nurhaedar Jafar, Apt, M.Kes
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Address
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Hasanuddin University
Perintis Kemerdekaan Street Km. 10 90245
Makassar-South Sulawesi
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Country
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Indonesia
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Phone
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+6281342768385
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Nurzakiah Hasan
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Address
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Hasanuddin University
Perintis Kemerdekaan Street Km. 10 90245
Makassar-South Sulawesi
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Country
82363
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Indonesia
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Phone
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+6281342226001
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof. Veni Hadju
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Address
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Hasanuddin University
Perintis Kemerdekaan Street Km. 10 90245
Makassar-South Sulawesi
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Country
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Indonesia
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Phone
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+62811441803
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Fax
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Email
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[email protected]
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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.
Download to PDF