Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000409673
Ethics application status
Approved
Date submitted
4/04/2023
Date registered
24/04/2023
Date last updated
20/02/2024
Date data sharing statement initially provided
24/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized control trial to test the effectiveness, feasibility, and acceptability of an education intervention promoting healthy lifestyle to reduce risk factors for metabolic syndrome, among office workers in Ethiopia.
Scientific title
Testing the effectiveness of an education interventions for healthy lifestyle on metabolic syndrome management as well as on knowledge, attitudes and practice towards cardiovascular risk factors and healthy lifestyle among bank workers in Ethiopia.
Secondary ID [1] 309358 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 329574 0
Obesity 329575 0
Diabetes 329576 0
Hypertension 329577 0
Cholesterol 329599 0
Condition category
Condition code
Cardiovascular 326492 326492 0 0
Hypertension
Diet and Nutrition 326493 326493 0 0
Obesity
Metabolic and Endocrine 326495 326495 0 0
Diabetes
Public Health 326496 326496 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted with bank workers because they are a high risk group, but are relatively educated. The intervention will consist of education about the concept of metabolic syndrome, risk factors, and prevention strategies, the significance of lifestyle modification such as exercise, healthy diets, avoiding harmful alcohol consumption, quitting smoking, and stress management, as well as motivation for changing behavior. The education will be delivered by health promotion and education experts on a one -one -one based for 1:30 hour. Hand out on promoting healthy lifestyle to reduce risk factors for metabolic syndrome which is developed by a researcher collaboration with nutritionist, psychologist and physiotherapist by using the World Health Organization recommendation for cardiovascular disease management which can be accessed at (https://www. who.int/publications-detail-redirect/ 9789240001367) . Every two weeks, the researcher will send a text message to the participants as a reminder and asking whether they follow the suggested diet, physical activity, and other intervention components. It will also inquire as to whether they recorded their actions using the offered self-report template. Throughout the intervention (for 9 months), the participants will be encouraged to ask questions, and seek guidance and reply to the texts by sending more texts inquiring as to whether they have any questions. Additionally, a review meeting lasting a half hour will be held at the 3rd and 6th month of the intervention to review the main points about prevention of metabolic syndrome and healthy lifestyle, and to assess obstacles faced to adhere to the intervention and define a strategy to overcome these barriers. Adherence to the intervention will be monitored by self-report checklists, attendance at review meetings, and text message answers.
Intervention code [1] 325791 0
Lifestyle
Intervention code [2] 325792 0
Behaviour
Intervention code [3] 325793 0
Prevention
Comparator / control treatment
General health advice about physical exercising, healthy diet, self-care and monitoring, according to the national guidelines recommended for non-pharmacological managements for each components of the metabolic syndrome. It will be provided by nurse professionals in an individual form.
Control group
Active

Outcomes
Primary outcome [1] 334340 0
Obesity (waist circumference). which will be measured using a tape measure at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest or at the abdomen’s maximum extension.
Timepoint [1] 334340 0
Baseline and 9 months after intervention commencement
Primary outcome [2] 334341 0
Blood pressure (BP). It will be measured using appropriate size sphygmomanometer.
Timepoint [2] 334341 0
baseline and 9 months after intervention commencement.
Primary outcome [3] 334451 0
Biochemical markers. Which will be assessed by laboratory analysis of fasting plasma glucose level, blood plasma total cholesterol, high density lipoprotein cholesterol, triglyceride level, and low-density lipoprotein cholesterol.
Timepoint [3] 334451 0
Baseline and 9 months after intervention commencement.
Secondary outcome [1] 420292 0
Intervention feasibility. Feasibility will be measured by a validated 4 item tool Feasibility of Intervention Measure (FIM).
Timepoint [1] 420292 0
At 6 months after intervention commencement
Secondary outcome [2] 420293 0
Acceptability of intervention. Acceptability will be measured by a validated 4 item tool Acceptability of Intervention Measure (AIM), and by theoretical framework for acceptability. Acceptability of Intervention Measure' and 'theoretical framework for acceptability a composite secondary outcome.
Timepoint [2] 420293 0
At 6 months after intervention commencement
Secondary outcome [3] 420294 0
Fidelity of the intervention. Fidelity will be assessed by participants and providers self-reports and researcher observations using checklists.
Timepoint [3] 420294 0
Throughout the intervention phase
Secondary outcome [4] 420295 0
Assessment of the implementation of the intervention. Implementation process will be evaluated by using consolidated framework for implementation research.
Timepoint [4] 420295 0
Throughout the intervention period
Secondary outcome [5] 420749 0
Knowledge about metabolic syndrome. Knowledge will be measured using the 43-item validated knowledge, attitudes, and practices on lifestyle and cardiovascular risk factors questionnaire which was developed and tested in India.
Timepoint [5] 420749 0
Baseline and 9 month after intervention commencement.
Secondary outcome [6] 420750 0
Attitude towards metabolic syndrome. Attitudes will be assessed using the 43-item validated knowledge, attitudes, and practices on lifestyle and cardiovascular risk factors questionnaire which was developed and tested in India.
Timepoint [6] 420750 0
Baseline and 9 month after intervention commencement.
Secondary outcome [7] 420751 0
Dietary habit, alcohol consumption, smoking and physical exercise practice: Which will be evaluated using short form food frequency questionnaire.
Timepoint [7] 420751 0
Baseline and 9 month after intervention commencement.
Secondary outcome [8] 431890 0
Cost benefit evaluation. It will be assessed by collecting the cost data for the intervention implementation activities. The cost benefit analysis will be made and the benefit would be outcome variables of the RCT and at the end we will compare them to how much costs are required for per unit of benefit.
Timepoint [8] 431890 0
Secondary outcome [9] 431891 0
Cost benefit evaluation. It will be assessed by collecting the cost data for the intervention implementation activities. The cost benefit analysis will be made and the benefit would be outcome variables of the RCT and at the end we will compare them to how much costs are required for per unit of benefit.
Timepoint [9] 431891 0
Throughout the intervention period
Secondary outcome [10] 431892 0
Stress: It will be measured by using the perceived stress scale.
Timepoint [10] 431892 0
Throughout the intervention period
Secondary outcome [11] 431893 0
Stress: It will be measured by using the perceived stress scale.
Timepoint [11] 431893 0
Baseline and 9 month after intervention commencement

Eligibility
Key inclusion criteria
Bank workers with age greater than or equal 18 years old and who fulfil at least one of the following National Cholesterol Education Program Adult Treatment Panel III (NCEP: ATPIII) metabolic syndrome criteria; Waist circumference >102 cm in men, > 88 cm in women, Triglycerides greater than or equal 150 mg/dl, HDL-cholesterol < 40 mg/dl in men and < 50 mg/dl in women, BP greater than or equal130/85 mmHg, fasting glucose greater than or equal110 mg/dl will be included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bank workers who have at least one of the NCEP: ATP III metabolic syndrome criteria but with dietary restrictions and absolute contraindication for physical activity due to musculoskeletal, neurological, vascular, lung and cardiac problems, pregnant mothers, lactating mothers, those who have a plan to be pregnant within the intervention months and diagnosis of severe psychiatric disorders, significant cognitive impairment, and those who will not available throughout the program will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using procedures like coin-tossing using work sites as a cluster.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined under the assumptions and using the formula of the sample size calculation for randomized control trial studies with continuous outcome variables. The means and standard deviations of systolic blood pressure were taken from a study with a similar design that was conducted in Ethiopia. A power of 80%, a 1:1 ratio, and a 95% confidence interval were used for calculation. By taking into account a 20% attrition rate, 226 total individuals or 113 individuals per group will be recruited for the study.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
20/11/2023
Date of last participant enrolment
Anticipated
1/11/2023
Actual
29/12/2023
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
226
Accrual to date
Final
226
Recruitment outside Australia
Country [1] 25365 0
Ethiopia
State/province [1] 25365 0
Amhara region

Funding & Sponsors
Funding source category [1] 313555 0
University
Name [1] 313555 0
National Center for Epidemiology and population health, the Australian National University.
Country [1] 313555 0
Australia
Funding source category [2] 313560 0
Self funded/Unfunded
Name [2] 313560 0
Mr Sitotaw Bogale
Country [2] 313560 0
Australia
Primary sponsor type
University
Name
National Center for Epidemiology and Population Health, the Australian National University
Address
National Center for Epidemiology and Population Health), address
62 Mills Rd, Acton ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 315333 0
Individual
Name [1] 315333 0
Mr Sitotaw Bogale
Address [1] 315333 0
National Center for Epidemiology and Population Health
62 Mills Rd, Acton ACT 2601
Australian National University
Country [1] 315333 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312736 0
Australian National University, Human Research Ethics Committee
Ethics committee address [1] 312736 0
Ethics committee country [1] 312736 0
Australia
Date submitted for ethics approval [1] 312736 0
24/03/2023
Approval date [1] 312736 0
31/08/2023
Ethics approval number [1] 312736 0
2022/845

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125722 0
Mr Sitotaw Bogale
Address 125722 0
National Center for Epidemiology and Population Health the Australian National University
62 Mills Rd, Acton ACT 2601
Country 125722 0
Australia
Phone 125722 0
+61 449733356
Fax 125722 0
Email 125722 0
[email protected]
Contact person for public queries
Name 125723 0
Sitotaw Bogale
Address 125723 0
National Center for Epidemiology and Population Health the Australian National University
62 Mills Rd, Acton ACT 2601
Country 125723 0
Australia
Phone 125723 0
+61 449733356
Fax 125723 0
Email 125723 0
[email protected]
Contact person for scientific queries
Name 125724 0
Sitotaw Bogale
Address 125724 0
National Center for Epidemiology and Population Health the Australian National University
62 Mills Rd, Acton ACT 2601
Country 125724 0
Australia
Phone 125724 0
+61 449733356
Fax 125724 0
Email 125724 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.