None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
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