Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000135314
Ethics application status
Approved
Date submitted
15/12/2016
Date registered
24/01/2017
Date last updated
24/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Intervention Program to Reduce the Risk Factors of Metabolic Syndrome in Malaysian Female University Staff with Polycystic Ovarian Syndrome
Scientific title
A Randomized Control Trial of Lifestyle Education Program to Reduce Risk Factors of Metabolic Syndrome Among Female Staff with Polycystic Ovarian Syndrome (PCOS) in University Putra Malaysia
Secondary ID [1] 290761 0
Non
Universal Trial Number (UTN)
U1111-1190-9842
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovarian Syndrome (PCOS) 301360 0
Metabolic Syndrome 301361 0
Condition category
Condition code
Metabolic and Endocrine 301109 301109 0 0
Metabolic disorders
Public Health 301110 301110 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name:
A randomized control trial of lifestyle educational program to reduce risk factors of metabolic syndrome among staff with polycystic ovarian syndrome (PCOS) in University Putra Malaysia
Rational:
PCOS is thought to affect 1 out of 10 women of childbearing age worldwide. As with other chronic illnesses, women with PCOS often have uncertain prognoses.. The prevalence of metabolic syndrome is reported to be as high as 45% among PCOS patients and is related to cardiovascular diseases (CVD). Single treatment of PCOS is not beneficial in reducing the risk of CVD unless the comorbidities (the most prevalent of which is metabolic syndrome) are treated as well. The best way of reducing the prevalence of metabolic syndrome is to provide strategies to prevent this syndrome. Education is the first line of prevention of diseases as well as metabolic syndrome.
Among the suggested theories with the aim of behaviour change in health sciences studies, information-motivation-behavioural skills (IMB) theory is being valued recently. According to the IMB model, relevant information, motivation to act, and behavioural skills for acting effectively are fundamental determinants of health behaviour change. The model defines that an individual’s information and motivation is performed by means of or is limited to the individual’s behavioural skills, in the performance of health behaviours. When novel or complex behavioural skills are not essential for the practice of a health behaviour, there may be a direct link from information or motivation to behaviour.
The IMB model was designed to address the limitations of the previous models which included lack of specification of critical constructs and absence of conceptual parsimony as well as constructs that might have an important effect on understanding and changing health related behaviours. In other words the IMB model focuses on the information and behavioural skills related factors that are conceptually and empirically associated with performance of health behaviour. In other words the individual is required to be well informed and motivated to perform health related behaviour.
This study will be conducted on University Putra Malaysia (UPM) staff in childbearing age (18-49) with PCOS diagnosis by using a newly designed lifestyle intervention program in order to reduce the risk factors for Metabolic Syndrome.
Materials:
Intervention groups will be provided with the following information.
1. Scheduled sessions for lifestyle education twice weekly. Duration of each session range from 45 minutes to one hour. A total of 48 sessions will be held during the course of the study (6 months). The curriculum of the classes is described below:
i. Introduction (1 session)
Topics
a) 'Who am I' (held by the researcher with Masters is Medical Science in Public Health)
b) Ice breaking and sharing moment (held by the researcher with Masters is Medical Science in Public Health)
c) Best food before, during and after exercise (held by a registered dietician)
d) Penalties (held by a professional trainer with Bachelor degree in Sport Science)

ii. Nutrition education (10 sessions)
Topics:
a) General nutritional tips (1 session): Role of diet and nutrition in the management of PCOS, Role of diet and nutrition in reducing the risk factors of metabolic syndrome, Nutrition recommendation in PCOS (held by a registered dietician)
b) Types of Diet (9 sessions): Traditional and religious diets (6 sessions), Diet during the fasting month (Fit Ramadan diet) (1 session), Diet after the fasting month (1 session) (held by a registered dietician)

iii. Variation of Exercise (32 sessions) (held by a professional trainer with Bachelor degree in Sport Science)
Topics:
a) Basic Body Workout (4 sessions)
b) Aquazumba / Water Workout (10 sessions)
c) Leg Workout (2 sessions)
d) Abs Workout (2 sessions)
e) Dance (7 sessions)
f) Combo Workout (6 sessions)
g) Cardio Workout (1 session)

iv. Motivation (2 sessions) (held by the researcher with Masters is Medical Science in Public Health)
v. Stress management (1 session) (held by the researcher with Masters is Medical Science in Public Health)
vi. Self-discipline (2 sessions) (held by the researcher with Masters is Medical Science in Public Health)
vii. Sleep and Rest (2 sessions) (held by the researcher with Masters is Medical Science in Public Health)
2. One session of physical activity every two weeks. These sessions include practicing the thought courses in the physical activity education sessions as well as recreational activity including Zumba dancing and Aqua Zumba (held by a professional trainer with Bachelor degree in Sport Science).
The total number of participants in the sessions will be 35 subjects.
Study duration
A previous study found that education intervention was capable of significantly improving biochemical and anthropometric characteristics of Malaysian subjects with metabolic syndrome. Therefore 6 months follow up was chosen as the duration of intervention for this study.
Mode of delivery
Education sessions will be held in the form of group counselling.
Location
Subjects will be informed to participate in a university hall in order to participate in education sessions while the exercise session will be held in University stadium with prior arrangements.
Fidelity assessment
Participation of subjects in education sessions as well as exercise sessions will be assessed at the end of the study. Verbal encouragements will be provided for subjects in order to make them maintain in the study. Subjects will also be called twice, one day and 2 hours prior to each session, as a reminder.
Subjects in each intervention or control group who fail to participate in the research, in terms of participation in education and exercise sessions (less than 80% of the sessions) and follow up sessions (assessment of the outcome measures) will be excluded from the study. Prior to exclusion, subjects will be informed and given 3 week time to resume the research. In case of failure to cooperate, the subject will be excluded.
Subjects will have to sign in at the beginning of each session and the absentees will be called prior to the next session. Absentees should report the reason for their participation refusal.
Subjects have the right to refuse to continue their participation at any time in the research. In case of refusal, researcher will contact the subject and ask for information about the reasons for refusal. If the reasons were manageable and alterations could not violate the ethical and scientific process of the research the subject will be asked to remain in the study after fulfilling her needs. Otherwise the subject will be excluded and the reason for refusal will be recorded by the researcher.
Intervention code [1] 296663 0
Lifestyle
Intervention code [2] 296664 0
Prevention
Intervention code [3] 296665 0
Behaviour
Comparator / control treatment
All subjects who are eligible for the intervention will be divided into two equal groups based on faculty locations and departments. Then one group was randomly allocated as case and the other group as control group. Therefore, the control group would be similar to the intervention group in terms of primary medical condition but are treated differently.
Control group will be provided with pamphlets and brochures, which contain general lifestyle recommendations for PCOS. The control group will be informed that they will receive the materials used for the education program for intervention group at the end of the study in order to reduce the drop out of the control group.
Control group
Active

Outcomes
Primary outcome [1] 300524 0
proportion of participants who reduced body weight by .5% .relative to baseline assessed using wight scales.
Weight is assessed using a calibrated weighting scale to the nearest 0.1 kg by the researcher.
Timepoint [1] 300524 0
at 3 months and six months after initiation of the intervention
Primary outcome [2] 300525 0
Proportion of participants who reduced or maintained body mass index (BMI) in the range of 25 and 30 kg/m2.
BMI is calculated based on the measured weight of the subjects, using a calibrated weighting scale, and their height, using a calibrated stadiometer to nearest 0.1 cm. Measurements are performed by the researcher. BMI is then calculated based on the following formula:
BMI(kg/m2)= (weight [kg])/(height [m])^2
Timepoint [2] 300525 0
at 3 and 6 months after the initiation of the intervention
Primary outcome [3] 300526 0
Proportion of participants who reduced waist circumference to below 80 cm relative to baseline assessed by measuring tape.
Waist circumference is measured by researcher between the lower costal (10th rib) border and the top of the iliac crest to the nearest 0.1 cm..
Timepoint [3] 300526 0
at 3 months and 6 months after initiation of the intervention
Secondary outcome [1] 330214 0
Proportion of participants who reduced fasting plasma glucose relative to baseline assessed by laboratory assessment of fasting plasma glucose.
Serum sampling is undertaken by a registered nurse and the samples are assessed in a certified laboratory by trained a technician.
Timepoint [1] 330214 0
at 3 months and 6 months after the initiation of the intervention
Secondary outcome [2] 330215 0
Proportion of participants who reduced HDL cholesterol relative to baseline assessed by laboratory assessment of fasting plasma glucose.
serum sampling is undertaken by a registered nurse and the samples are assessed in a certified laboratory by trained a technician.
Timepoint [2] 330215 0
at 3 months and 6 months after the initiation of the intervention
Secondary outcome [3] 330216 0
Proportion of participants who reduced LDL cholesterol relative to baseline assessed by laboratory assessment of fasting plasma glucose.
Blood sampling is undertaken by a registered nurse and the samples are assessed in a certified laboratory by trained a technician.
Timepoint [3] 330216 0
at 3 months and 6 months after the initiation of the intervention
Secondary outcome [4] 330217 0
Proportion of participants who reduced blood pressure relative to baseline assessed by sphygmomanometer.
Blood pressure is measured by researcher who has a medical/health degree using a calibrated electronic sphygmomanometer.
Timepoint [4] 330217 0
at 3 months and 6 months after the initiation of the intervention

Eligibility
Key inclusion criteria
Female gender
Being a university staff
Being a permanent Malaysian citizen
Being diagnosed with PCOS
Age between 18 and 49 years
Willingness to participate in the study by signing the consent form
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Physical disability (amputation, stroke) or serious health problems that require admission
2. Consumption of oral contraceptives for more than 4 weeks or hormone treatment/insulin-sensitizing agents for more than 2 weeks. Consumption of any vitamins or medications that do not affect the metabolic syndrome criteria are permitted for the subjects.
3. Hyperprolactinemia, thyroid abnormalities,or nonclassic adrenal hyperplasia

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)
The university will be devided into two geographical regions that would prevent the contact between intervention and control groups.Subjects will be divided into two equal groups based on faculty locations and departments. Then one group will be randomly allocated as case and the other group as control group using a random number generator software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Descriptive analysis will be used to describe study variables at baseline, after 3 months and 6 months. Data will be checked for normality distribution using the Kolmogrov-Smirnov test of normality. Mean and standard deviation (SD) will be shown to describe normally distributed data whereas median and interquartile range (IQR) will be used to describe non-normally distributed data. Categorical data including level of education and BMI category will be described as frequency of the sub categories.
Comparison of study variables between intervention and control groups will be performed using independent t-test for normally distributed data and Mann-Whitney test for non-normally distributed data. Distribution of categorical data will be compared between intervention and control groups using cross tabulation and chi-square test.
Correlation analysis will be used to identify the correlation between continuous variables. Pearson correlation will be used for normally distributed data while the Spearman correlation will be used for the non-normally distributed data. Interpretation of the correlation analysis will result in identifying possible confounders (such as age, education level, etc.).
The effect of education intervention on the criteria of metabolic syndrome will be assessed using the two-way repeated measures ANOVA.
The confidence limit (a) will be considered as 95% and p values lesser than 0.05 will be considered as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
1/03/2016
Date of last data collection
Anticipated
Actual
31/08/2016
Sample size
Target
85
Accrual to date
Final
69
Recruitment outside Australia
Country [1] 8508 0
Malaysia
State/province [1] 8508 0
Selangor

Funding & Sponsors
Funding source category [1] 295190 0
Government body
Name [1] 295190 0
Ministry of Science, Technology and Innovation (MOSTI)
Country [1] 295190 0
Malaysia
Primary sponsor type
University
Name
University Putra Malaysia (UPM)
Address
School of Graduate Studies
Zone 4, Off Jalan Stadium
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan, MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 294018 0
None
Name [1] 294018 0
Address [1] 294018 0
Country [1] 294018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296542 0
Medical Research Ethics Committee of the Faculty of Medicine and Health Sciences, UPM
Ethics committee address [1] 296542 0
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Lorong Asam Jawa 1, Selangor, 43400 Serdang, Malaysia
Ethics committee country [1] 296542 0
Malaysia
Date submitted for ethics approval [1] 296542 0
03/10/2013
Approval date [1] 296542 0
13/01/2014
Ethics approval number [1] 296542 0
UPM/TNCPI/RMC/JKEUPM /1.4.18.1/F1

Summary
Brief summary
Prevalence of metabolic syndrome (PCOS) is reported to be high among women with polycystic ovarian syndrome (PCOS). Metabolic syndrome is an independent risk factor for mortality due to cardiovascular diseases (CVD). Prevention of metabolic syndrome is a priority for public health interventions and lifestyle education and is considered as the cornerstone of prevention. The aim of this study was to provide an education model to prevent metabolic syndrome among PCOS patients.
Validation of the education intervention will be performed in phase three by conducting a randomized controlled trial (RCT) on 82 women with PCOS who are randomly allocated to intervention and control groups. Subjects will be selected among university staff who age between 18 and 49 years.
All subjects, including intervention and control groups will undergo anthropometric and clinical and laboratory assessments as follows. All subjects will be measured for weight, height and waist circumference by a registered dietitian and the BMI is calculated for each subject. The blood pressure of the subjects will be measured by the researcher with Masters degree in Medical Science (Public Health) and history of health care work for 2 years. Blood samples will be taken from all subjects by a registered nurse in order to measure serum triglyceride (TG), total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and fasting plasma glucose (FPG) as well as total and free testosterone and prolactin levels. Serum prolactin levels will be used to exclude subjects with other medical conditions than PCOS. Sociodemographic questionnaire will be filled by all subjects at baseline. Subjects will be assessed for anthropometric characteristics, body composition, TG, total cholesterol, HDL cholesterol, LDL cholesterol and FPG at baseline and at 3rd month and 6th month of intervention.
Subjects in intervention and control group will receive pamphlets and brochures containing general health tips and recommendations while the intervention group receive 48 sessions of education on lifestyle modification held twice per week along with exercise sessions, which will be held once every two weeks. All subjects will be assessed for outcome measures as described earlier.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71206 0
Prof Latiffah Abd Latiff
Address 71206 0
Department of Community Health
Faculty of Medicine& Health Sciences,
Universiti Putra Malaysia,
43400 UPM , Serdang,
Selangor , Malaysia.
Country 71206 0
Malaysia
Phone 71206 0
+60 3 8947 2537
Fax 71206 0
+60 3 8945 0151
Email 71206 0
[email protected]
Contact person for public queries
Name 71207 0
Dr Sareh Dashti
Address 71207 0
Department of Community Health
Faculty of Medicine& Health Sciences,
Universiti Putra Malaysia,
43400 UPM , Serdang,
Selangor , Malaysia.
Country 71207 0
Malaysia
Phone 71207 0
+60 18 356 1233
Fax 71207 0
Email 71207 0
[email protected]
Contact person for scientific queries
Name 71208 0
Dr Sareh Dashti
Address 71208 0
Department of Community Health
Faculty of Medicine& Health Sciences,
Universiti Putra Malaysia,
43400 UPM , Serdang,
Selangor , Malaysia.
Country 71208 0
Malaysia
Phone 71208 0
+60 18356 1233
Fax 71208 0
Email 71208 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial on the effects of a structural education module among women with polycystic ovarian syndrome on nutrition and physical activity changes.2022https://dx.doi.org/10.1186/s12905-022-01861-4
N.B. These documents automatically identified may not have been verified by the study sponsor.