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Trial registered on ANZCTR


Registration number
ACTRN12616001699459
Ethics application status
Approved
Date submitted
17/11/2016
Date registered
9/12/2016
Date last updated
9/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of educational intervention on knowledge, belief and self-efficacy regarding osteoporosis among the female academic staff in Universiti Putra Malaysia
Scientific title
Effectiveness of educational intervention on knowledge, belief and self-efficacy regarding osteoporosis among the female academic staff in Universiti Putra Malaysia
Secondary ID [1] 290565 0
Nil known
Universal Trial Number (UTN)
U1111-1189-9847
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knowledge, belief and self-efficacy regarding osteoporosis among the female academic staff in Universiti Putra Malaysia 301014 0
Condition category
Condition code
Public Health 300809 300809 0 0
Health promotion/education
Musculoskeletal 300810 300810 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
*The study will be conducted among the female staff in Universiti Putra Malaysia, Serdang. According to university website (www.upm.edu.my; 2015) total female staff is about more than one thousand. Only academic female staff of this university will be included in this study.
* Respondents who meet the inclusion criteria will be taken as respondent by multi stage random sampling.
*There are sixteen different faculties in Universiti Putra Malaysia; eight different faculties will be allocated for each intervention and control group to achieve the sample size.
*Respondents for both intervention and control group will be single blinded to reduce bias. The respondent will not be informed whether they are categorized under intervention or control group. Only the researcher is able to differentiate which groups are under intervention or control group.
* The intervention group will receives information’s about osteoporosis by education material and control group will not receive any information’s related to osteoporosis. After the completion of the trial the control group will receive the educational material through email.
*Researcher herself will distribute the booklet (educational material) which will includes the information on development, risk, consequences and prevention strategies of osteoporosis among the intervention group.
*Educational material (booklet) develop under “Health Belief Model” will be prepared by principal investigator specifically highlight the study objectives by comprehensive literature review from previous studies.
*All participants will answer a set of validated and pretested questionnaire at baseline, immediately and three months after intervention.
*To reduce the noncompliance in the study the researcher will send weekly mobile text to the intervention group for gentle reminder.
*Text messages will be delivered once in a week for three months in only in intervention group.
*The text message will contain the key messages from each six parts of “Health Belief Model” (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, self-efficacy)which will be summarize from the intervention module.
*The certificate of the participation will be given upon completion of the study.
Intervention code [1] 296431 0
Lifestyle
Intervention code [2] 296432 0
Behaviour
Intervention code [3] 296433 0
Prevention
Comparator / control treatment
There will be no intervention in control group and they will remain in wait list until the data collection finished. After finish the data collection for intervention group(beginning until three months of data collection) the control group will receive the intervention module immediately.
Control group
Active

Outcomes
Primary outcome [1] 300232 0
Osteoporosis knowledge assessed by questionnaire designed for this study
Timepoint [1] 300232 0
At baseline, immediately after intervention commencement and at 3 months after intervention commencement
Primary outcome [2] 300299 0
Osteoporosis self-efficacy assessed by questionnaire designed for this study
Timepoint [2] 300299 0
At baseline, immediately after intervention commencement and at 3 months after intervention commencement
Primary outcome [3] 300300 0
Osteoporosis belief assessed by questionnaire designed for this study
Timepoint [3] 300300 0
At baseline, immediately after intervention commencement and at 3 months after intervention commencement
Secondary outcome [1] 329436 0
Proportion of participants with an improve Osteoporosis Knowledge Test (OKT) score
Timepoint [1] 329436 0
Immediately after intervention commencement and at 3 months after intervention commencement
Secondary outcome [2] 329649 0
Proportion of participants with an improve Osteoporosis Self-Efficacy Scale (OSES)
Timepoint [2] 329649 0
Immediately after intervention commencement and at 3 months after intervention commencement
Secondary outcome [3] 329650 0
Proportion of participants with an improve Osteoporosis Health Belief Scale (OHBS).
Timepoint [3] 329650 0
Immediately after intervention commencement and at 3 months after intervention commencement

Eligibility
Key inclusion criteria
i. Female academic participants are working as a full time staff in UPM.
ii. Female academic participants age in between 25-55 years.
iii. Female academic participants with English language
iv. Female academic participants will give written consent.
v. Female academic participants will not going for leave in coming three months.
vi. Female academic participants are using smart mobile phone with internet subscription.
Minimum age
25 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i. Female academic participants diagnosed as osteoporosis.
ii. Female academic participants come for short time training
iii. Pregnant Female academic participants
iv. Female academic participants has chronic disease with medication (e.g. Hypertension/Diabetics)
v. Active female academic participant in another study.
vi. Female academic doctor and nurse staff

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All the female academic staff who meet the inclusion criteria will be taken as respondent by multi stage random sampling. There are sixteen different faculties in Universiti Putra Malaysia which are located in 1108,103 hectares area in Serdang, Selangor, Malaysia; therefore different faculty is located in different location which is named as main campus and extended campus. All non-health science faculties are situated in main campus and Health Science, Agriculture and Veterinary faculties are located in extended campus.
Therefore, in order to get estimated sample, The UPM area will be divided into two zones and each zone will randomly assign to one of the study group, named as Zone A and Zone B. Each faculty will be assign with a number as follows: Faculty 1:Agriculture, Faculty 2:Forestry, Faculty 3:Veterianary, Faculty 4: Economic And Management, Faculty 5: Engineering, Faculty 6: Educational Studies, Faculty 7: Science, Faculty 8:Food Science And Technology, Faculty 9:Human Ecology, Faculty 10:Modern Language, Faculty 11:Medicine And Health Science, Faculty 12:Design And Architecture, Faculty 13:Computer Science, Faculty 14: Biotechnology, Faculty 15: Environmental Study and Faculty 16 Agriculture And Food Science.
Once UPM area will separate into two zones, there will be eight faculties in each Zone. The name of all the faculties will be written in piece of paper separately and drawn lottery to assign individual Zone A and Zone B. The name of first lottery drawing will be Zone A and second drawing will be Zone B. Once randomly selected name of each zone, they will be randomly assigned to study groups; control and intervention group. This will be done by using one column of random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will analyze by using SPSS, version 22 and the significance level will be set at P<0.05. Intention to treat (ITT) analysis concept will be employed for final analysis. By this concept, all respondents in intervention are analyzed by randomized treatment assignment. This will be regardless of the noncompliance status, deviation from protocol, attrition and or any other occurrences after randomization. Descriptive analysis including calculations of means, 95% confidence intervals (CI) of means and frequencies of categorical variables will be presented at the baseline socio-demographic and behavioral characteristics for osteoporosis prevention among the female staff in Universiti Putra Malaysia. It will be also used to qualify the level of knowledge before and after the intervention. Paired T test and repeated measure ANOVA test will be used to determine the effectiveness of the intervention program by comparing the pre and posttest of knowledge on osteoporosis. Chi-square will determine the prevalence of osteoporosis by the intervention program and the outcome variable. Intra-class correlation will be computed to test for any design effect on outcome variables. If there are any designs effect revealed in this result, General Linear Modelling (GLM) will be used to assess the impact of condition (intervention, control) across baseline and 3 months intervention. Multivariate Repeated Measures Analyses (MANOVA) will be conducted to allow examination of whether the group means changed statistically significantly over the different time periods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 8402 0
Malaysia
State/province [1] 8402 0
Selangor

Funding & Sponsors
Funding source category [1] 295002 0
Self funded/Unfunded
Name [1] 295002 0
Samia Amin
Country [1] 295002 0
Malaysia
Primary sponsor type
Individual
Name
Samia Amin
Address
Department of community medicine,Faculty of Medicine and Health science,Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 293818 0
Individual
Name [1] 293818 0
Assoc. Prof. Dr. Hejar Abdul Rahman
Address [1] 293818 0
Department of community medicine,Faculty of Medicine and Health science,Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country [1] 293818 0
Malaysia
Secondary sponsor category [2] 293819 0
Individual
Name [2] 293819 0
Dr. Suriani Ismail
Address [2] 293819 0
Department of community medicine,Faculty of Medicine and Health science,Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country [2] 293819 0
Malaysia
Secondary sponsor category [3] 293820 0
Individual
Name [3] 293820 0
Dr. Emilia Zainal Abidin
Address [3] 293820 0
Department of Environmental and Occupational Health,Faculty of Medicine and Health science,Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country [3] 293820 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296355 0
JKEUPM (Ethic Committee For Research Involving Human Subject)
Ethics committee address [1] 296355 0
Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Ethics committee country [1] 296355 0
Malaysia
Date submitted for ethics approval [1] 296355 0
22/07/2016
Approval date [1] 296355 0
12/10/2016
Ethics approval number [1] 296355 0
UPM/TNCPI/RMC/JKEUPM/1.4.18.2 (JKEUPM)

Summary
Brief summary
Osteoporosis is a global health problem along with heart disease, stroke, diabetes and cancer which not only causes increase economic burden, it also leads to social, physical and psychological consequences. It is considered as woman’s chronic health problem which is characterized by decreased bone mass density, micro architectural deterioration of bone tissue and fragility fractures, particularly to the hip, spine, wrist and shoulder. The United States Department of Health and Human Services estimated that osteoporosis affect more than 75 million people worldwide which projects that the disease will impact more than 10 million women by 2020 if efforts to prevent it are ineffective. It is a silent undiagnosed disease until a fracture occurs due to an accidental fall. Worldwide osteoporosis causes more than 8.9 million fractures annually, resulting in an osteoporotic fracture every 3 seconds. Although it can affect either gender, 80% of those affected are women. Worldwide, 1 in 3 women over age 50 will experience osteoporotic fractures, as will 1 in 5 men aged over 50. So, the objective of this study is to develop, implement and evaluate effectiveness of an educational intervention program on prevention of Osteoporosis based Health Belief Model among the female staff in Universiti Putra Malaysia. Single blinded, randomised controlled trial will be conducted among female academic staff in Universiti Putra Malaysia. After cluster sampling, total 240 samples will be allocated in intervention and control group. Intervention group will expose to educational module and follow up for three months to measure the outcomes. The intervention group will give prevention of osteoporosis knowledge based on Health Belief Model and the control group will in wait list. The health promotion intervention program is expected to produce a significant difference in osteoporosis knowledge score, osteoporosis self-efficacy scale and osteoporosis health belief scale among female staff in Universiti Putra Malaysia between the intervention group and the control group. The data will analyse by computer software SPSS version 22 and the descriptive statistics, paired t test, repeated measure ANOVA, chi square, general linear model and MANOVA will do to measures the outcome. Results from this study about knowledge, belief and self-efficacy regarding osteoporosis among the female academic staff in UPM will help to identify areas that need focus and enforcement.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70566 0
Dr Samia Amin
Address 70566 0
Department of community medicine,Faculty of Medicine and Health science,Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country 70566 0
Malaysia
Phone 70566 0
+60142996859
Fax 70566 0
Email 70566 0
drsamia27@gmail.com
Contact person for public queries
Name 70567 0
Dr Samia Amin
Address 70567 0
Department of community medicine,Faculty of Medicine and Health science,Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country 70567 0
Malaysia
Phone 70567 0
+60142996859
Fax 70567 0
Email 70567 0
drsamia27@gmail.com
Contact person for scientific queries
Name 70568 0
Dr Samia Amin
Address 70568 0
Department of community medicine,Faculty of Medicine and Health science,Universiti Putra Malaysia,Jalan Upm, 43400 Serdang, Selangor, Malaysia
Country 70568 0
Malaysia
Phone 70568 0
+60142996859
Fax 70568 0
Email 70568 0
drsamia27@gmail.com

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Results publications and other study-related documents

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