Study design
The present study was carried out as an unmasked controlled trial to examine the effect of a pedometer-based intervention, in conjunction with BCTs on the basis of a theoretical framework on step-counts, PA and weight of women with PCOS referral to Mahdieh hospital Tehran, Iran, in 2017. To design and write this article, Consort 2010 checklists and flow diagram were used(21). Sampling was performed by random assignment method with 1:1 ratio and permuted block randomization. In this method, because of the two groups several blocks with letters A and B were identified. The size of each block was 4. The sample size was divided by the size of the block to obtain the number of blocks. Since the sample size was 88, 22 blocks were estimated. Each block specifies the status of 4 clients. The website www.randomization.com (22) was used to build the randomization sequence. To conceal generated lists, the lists with letters A and B in the specified order were put in thick envelopes by first author, who did not involve in the processes of intervention, and then the serial numbers were written on all envelopes. According to the mean and standard deviation of steps-counts in Becker and colleagues’ study(23) as well as G-power software, the sample size was calculated. In G-power software, using F family test, repeated measure ANOVA test, the effect size= 0.35, β= 0.90, α= 0.05, by 12 times pointes measuring step-counts, and correlation coefficient= 0.7, the sample size was calculated 33 in each group. Considering 30% dropout rate, the sample size reached 44 people in each group at the beginning of the study.
Participants
The study populations were women with PCOS referral to Mahdieh hospital in Tehran. The inclusion criteria were PCOS according to the gynecologist diagnosis, age range of 18-40 years, written and oral consent to participate in study, literacy, lack of disability and movement limitation, lack of mental disorder, and lack of a chronic disease not allowed by the physician to perform PA such as advanced diabetes and cardiovascular disease, etc. The exclusion criteria included pregnancy and lactation, hormonal drugs use, using infertility treatments methods, and smoking.
Measurement of outcome
Primary outcome
The primary outcome was PA that was measured in two ways. Objective PA or step-counts was measured using the Rossmax PA-S20 pedometer, a two-by-two-size electronic tool that is attached to the belt and displays step-counts. The validity and reliability of pedometer for measuring step-counts were supported (24). Subjective or self-reported PA was measured using the International Physical Activity Questionnaire (IPAQ) long form. The IPAQ is used as a standardized instrument to estimate PA among populations from different countries and cultural contexts.(25) It involves 7-day recall of PA. This questionnaire consists of 27 items and assesses the time spent in walking, moderate and vigorous activity within the domains of work, leisure time, transportation, domestic and gardening(25). Total scores for PA were calculated based on metabolic equivalents (MET) minutes per week and PA levels were classified as low (MET ≥ 600), moderate (600 < MET < 3000) and vigorous (MET > 3000)(25). In 2003, Craig et al. analyzed the validity and reliability of the IPAQ in 12 countries (26). Baghiani Moghaddam and colleagues also investigated the validity and reliability of the Persian version of IPAQ among Iranian women(27).
Secondary outcomes
Predisposing, enabling, and reinforcing factors which influence PA behavior were secondary outcomes of current study. According to the educational phase of the PRECEFE framework, predisposing, enabling, and reinforcing factors play an important role in the appearance of a behavior(15). Predisposing factors come prior to behaviors and include knowledge, attitudes, beliefs, existing skills, self-efficacy, and personal preferences that facilitate or prevent the motivation for change(15, 28). Reinforcing factors are followed by a behavior providing continuous reward and motivation for the emergence or repetition of a behavior. For example, they include social support, significant others, peer influence, positive/negative behavioral outcomes, and reward by others(15, 28). The factors that are antecedents to behavior and allow a motivation or environmental policy to be achieved are called enabling factors; such as the existence and access to resources and services, new skills, programs, rules and regulations(15, 28). In this study, to measure predisposing, reinforcing, and enabling factors, a self-administered questionnaire was designed based on the previous researches(17, 18). This questionnaire consisted of two parts. The first part included 10 demographic questions and the second part consisted of the questions related to predisposing factors (6 knowledge items, 7 attitude items, and, 9 self-efficacy items), reinforcing factors (5 social support items and 4 behavioral outcomes items), and enabling factors (2 items of new skills, 2 items of resources and 3 items of rules and policies). The items of knowledge, enabling factors, and behavioral outcomes were with a 3-point scale from 1=yes, 2=I do not know/somewhat and 3=no and other items rated with 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). After developing the questionnaire, its validity and reliability was measured. To determine face validity, the items with impact score equal or greater than 1.5 were considered as reasonable by10 participants with the same characteristics of the target population (29). The content validity index (CVI) and content validity ratio (CVR) of items were also investigated by 10 experts in health education and midwife. The score of CVR was calculated according to the necessity of each item, and a score equal or higher than 0.62 on the basis of the Lawshe table was envisaged a good content validity. To determine the CVI, the correlation criteria, clarity, and simplicity of each item were computed and a score equal to or higher than 0.79 was considered as reasonable (29). In addition to validity, the reliability of the questionnaire was assessed through internal consistency(29) by 15 participants with the same characteristics of the target population. Cronbach's Alpha coefficient for all constructs ranged from 0.71-0.91. Weight as other secondary outcome of this study was also calculated through an accurate scale in kilogram. All questionnaires were completed by interview and all outcomes were measured by a person outside the research team.
Ethical considerations
The study protocol was approved by the ethics committee of the Alborz University of Medical Sciences 2016 (approval No. Abzums. Rec.1395.23). All women participating in the study were informed about the objectives of research and assured about the confidentiality of their information. In addition, informed written consent forms were completed by participants in both groups. This study protocol was registered in the Iranian Registry of Clinical Trials as IRCT20161116030923N3. In order to comply with ethical consideration, the comparison group was benefited from theory-based intervention at the end of the study.
Theory-based educational intervention
A pedometer (Rossmax PA-S20 Pedometer), a calendar to record daily steps, an educational video and a pamphlet about using pedometer, and face-to-face training were given to all participants. Both intervention and comparison groups participated in 12-week pedometer-based walking program. All participants were told not to consider step-counts in the first two weeks and to record their daily steps in the calendar after two weeks and report it to the educator or a team leader at the end of per week. At the beginning of the study, the questionnaires were completed by the eligible individuals in both groups and their weight was also measured. In addition to 12-week pedometer-based walking program, the patients in the intervention group participated in four sessions of behavior change intervention based on predisposing, enabling and reinforcing factors. Since it was not possible to simulate educational intervention for both groups, an unmasked trial was performed. The training sessions were held once a week for 60 minutes. The patients in the intervention group were divided into four groups and a team leader was assigned for each group to timely announce training sessions and receive step-counts. For this purpose, a Telegram Group as "Increasing Step-counts by using Pedometer" was created and all individuals in the four groups joined the network.
First, on the basis of the PRECEDE framework, the factors associated with PA were identified in three categories of the predisposing, enabling, and reinforcing factors, then, according to the taxonomy table of BCTs (14, 16, 30), the relevant BCTs were selected for each factor. In predisposing category, a purpose was to increase patients' knowledge about using the pedometer, the PA pyramid, and the importance of regular PA in controlling and reducing the complications of PCOS. Other purposes in this category were positive attitude towards increasing step-counts, and enhancing patients' self-efficacy to increase step-counts. The consciousness raising technique was used in predisposing category to increase patients' awareness. In addition, on Telegram Group, the video and the pamphlet of working with pedometer, the pamphlet of PCOS and the PA pyramid were shared as cues to increase patients’ awareness. Repeated measure technique was used for modifying attitude such that participants in training sessions and on Telegram Group were repeatedly exposed to the message of increasing step-counts by 10,000 steps /day. The participants were encouraged to increase step-counts to 10,000 daily steps by using goal setting method. Set graded tasks method was also used to modify self-efficacy for increasing step-counts. To this end, the complex and difficult behavior of 10,000 daily steps was divided into smaller and simpler tasks. This enhanced the understanding and perception of patients that PA behavior could be performed without difficulty. For this purpose, it was explained that every 15 minutes of walking could increase step-counts to 3200-3800 steps. Another technique for increasing self-efficacy in current study was self-monitoring. To this end, the patients was given a weekly calendar, and they were asked to record their steps in the calendar and report it to team leader or the educator through Telegram Group at the end of the week. Also, the patients were contracted to increase step-counts to 10,000 daily steps by using the commitment technique, and the patients committed to walk 10,000 steps /day.
In enabling category, the purpose was to promote the new skills, availability and accessibility of resources and programs to increase step-counts. Guide practice technique was used to enhance the skill of using the pedometer. The educator trained the patients on how to use the pedometer via face-to-face method, and then they were asked to set up the pedometer on their waist and walk a few steps, and read step-counts on the pedometer. The resources such as the pedometers, the pamphlets, calendar, the educational videos, informative and persuasive massages to increase steps, Telegram Group, training sessions, individual consultations, group discussions and 12-week follow-up were provided for the patients. Some structural barriers to PA were mentioned by the participants such as insecurity of parks and sidewalks for walking, polluted air, lack of gyms in the apartments, the distance from the gym, and lack of easy access to the gyms. Planning coping responses technique was used to overcome structural barriers associated with PA. The patients in group discussions identified the barriers associated with PA and reaching 10,000 steps /day and by using brainstorming technique suggested solutions for coping with these obstacles.
In reinforcing category, the purpose was to enhance social support and behavioral outcome in order to increase step-counts. The importance of networking was taught as a way to expand social support. The patients were advised to use the company of their family members or friends to increase their step-counts. They were also told that encouraging each other for walking and doing it in a group is more enjoyable and encouraging. The social comparison technique was used to create a competitive group in increasing step-counts. In addition, reinforcement technique was applied for increasing step-counts. For this purpose, the women who reported more steps were encouraged and rewarded in training sessions. The direct experience and feedback method were used to improve behavioral outcome, meaning that, in training sessions, the women in the intervention group expressed their feelings and status by increasing step-counts and the educator also gave them positive and negative feedback on their performance.
Data analysis
After data collection, data were entered into SPSS.19 software. In the primary analysis, PA variable and its levels such as low, moderate, vigorous, and total PA, as well as also predisposing, enabling, and reinforcing factors were created by using of the collected data. To assess the normality of data, central tendency, histogram, and Shapiro-Wilk test were used. In case of non-normal distribution of variables, log-transformation was used. In current study, log-transformation was used to make the non-normal distribution data of the levels of PA and weight closely to the normal distribution. In the primary analysis, STATA software version 13 was used to analyze the objectives and assumptions of the study. Independent t-test, ANOVA ANCOVA and Repeated Measure ANOVA were applied for primary analysis. There was a sphericity presumption or reliability of the correlation at time points. Post-hoc analysis was also used for secondary analysis. To assess the relationship power, Cohen’s d effect size was used. The effect size classification based on Cohen’s d is interpreted as non- effective areas for the value of 0.1, small effect for 0.2-0.4, moderate effect for 0.5-0.7, and strong effect for 0.8 and above(31).