1. Study design and sample: This quasi-experimental study was conducted in Iran from February 2021 to December 2021. Infertile women with PCOS were recruited from a referral PCOS clinic of an infertility center. Ethical approval was obtained from Babol University of Medical Sciences, Babol, Iran (Ethics ID: IR.MUBABOL.REC.1399.497) and the principles of the Helsinki Declaration were followed. At the onset of the study, written informed consent with guarantee confidentially is obtained from 88 infertile women attending the PCOS clinic, who were willing to participate in this study, were recruited.
In this study, infertile women with PCOS (based on the Rotterdam criteria), aged 18–35 years, who had attempted to conceive in the last year, were included. The exclusion criteria were as follows: BMI < 25 kg/m2; past or current psychological problems and use of psychiatric medications; any type of disorder causing movement restrictions, such as cardiovascular disorder, skeletal problems, and joint inflammation; and history of attendance in similar training counseling sessions in the last six months.
A total of 78 women (88.6%) were selected for this study. In this phase, the participants’ anthropometric index was measured by the researcher. Besides, the participants completed a self-report demographic questionnaire, a reproductive information questionnaire, the Lifestyle Questionnaire (LSQ), and the International Physical Activity Questionnaire (IPAQ) at baseline [19]. They were randomly allocated into two groups, that is, a coaching group and a control group receiving routine care, based on the permuted block technique (with a block size of four). Since blinding was not possible, this study was conducted as an open-label trial.
In this study, a four-month intervention was implemented by completing the questionnaires in the pre-intervention (T1) and post-intervention (T2) stages. Two participants became pregnant in each group (39 women per group) during the intervention and were excluded from the study; also, four women (6.4%) were unwilling to continue the study or were unavailable. Finally, 70 (89.7%) women (coaching group = 36, control group = 34) completed the tools in the post-intervention stage (T2). The participants’ adherence was similar in the two groups. Both groups received 500 mg of metformin hydrochloride (Exir Pharmaceutical Distribution Company, Iran) twice a day, based on the relevant therapeutic protocol of our infertility center. The anthropometric index of all women was measured by another researcher after the intervention (T2) under the supervision of the principal investigator to decrease the risk of bias in the outcomes (Fig. 1).
2. Intervention: All women in the coaching group were informed about the health coaching process at the start of the intervention, which included six phone call-based health coaching sessions, ranging from 30 to 45 minutes in duration every two weeks. Health coaching was performed by a midwife coach (a trained researcher coach), who had received a coaching certificate from the Coaching Academy of Iran. All health coaching phone calls were made under the supervision of a supervisor, who had participated in the coaching course. The participants were allowed to call the coach at any time.
The goals of phone call-based health coaching sessions were briefly as follows: 1) promotion of a positive approach through training and development of skills; 2) providing verbal and written access to evidence-based information on the symptoms of PCOS; 3) minimizing unhealthy lifestyles; 4) providing education on problem-solving methods and activity planning sheets; 5) optimization of time management in daily activities; and 6) promotion of active supervision of anthropometric indicators and daily activities.
The GROW model, with four key stages of goal, reality, options, and will, was used during health coaching phone sessions. This model provides a simple method of problem-solving and goal setting by focusing on the actions and outcomes. The goal of the coaching session zero was to establish an open and effective communication with the participants. In this interaction, a brief overview of PCOS, its role in infertility, and management of overweight was presented in an effective manner. At the end of each session, the main discussed ideas were summarized, and feedback was provided.
Additionally, specific, measurable, achievable, relevant, and time-bound (SMART) objectives were set for corporate goal setting to investigate women’s ideas and use of time and to focus their efforts. Next, the GROW process was applied to achieve one of the predetermined goals, such as reduction of unhealthy lifestyle habits, limitation unhealthy meals and unhealthy foods, enhancement of quality of life, and weight loss. Overall, the intervention was performed for the purpose of conception. Besides, weight loss recommendations were made on how to focus on weight loss, especially by increasing PA, improving decision-making skills, and providing psychological support for behavioral change.
To motivate the participants, the pain-pleasure principle was used to define and achieve the goals of each session. Also, in each session, barriers to achieving the goals were specified. Moreover, new solutions and suitable questions were formulated in collaboration with the authorities. In the action stage, obligations, rewards for achieving the goals, and consequences were defined for the objectives. In the final session, a plan was designed for achieving the goals. At the end of each phone conversation, the start and end time of the call with the coach, duration of conversations, and common problems raised by the coach were documented by the coach.
3. Study variables and data collection tools: The demographic questionnaire included the following information: age, education level, occupation, and place of residence. The level of education was categorized into lower education, high school education, and university degree. The occupational status of the participants was also classified into employed and housewife, and the place of residence was classified into rural and urban.
The self-report reproductive questionnaire included data on the menarche age (< 13 years and ≥ 13 years), menstrual cycle status (regular/irregular), number of births, number of children, duration of infertility, use of oral contraceptives (OCs)/progesterone in the last six months, and type of infertility (primary or secondary).
The long version of IPAQ, which includes 27 questions in four domains, was used in this study to determine the participants’ habitual PA in the last seven days. This questionnaire is suitable for the assessment of adult PA in many settings and in different languages [20]. Vasheghani-Farahani et al. reported that the long version of IPAQ is sufficiently reliable and valid for measuring PA in the Iranian population [21]. According to this questionnaire, total PA (excluding sitting) and each type of PA were converted to metabolic equivalent scores (MET-min/week), and the sedentary time was determined as the sitting time per week in minutes (min/week) [19]
The LSQ, which consists of 70 questions and 10 domains of lifestyle to evaluate normal daily activities, was used in this study. The domains of the questionnaire include physical health, exercise and health, weight control and nutrition, disease prevention, mental health, spiritual health, social health, drug avoidance, accident prevention, and environmental health. The Iranian version of this questionnaire included 68 Likert-scale questions (from 0 to 5), and its reliability was confirmed by Cronbach’s alpha coefficients (0.85 to 0.94). The total score for each domain ranged from zero to 24. The maximum score of the questionnaire was 204, and the minimum score was zero [22].
The anthropometric variables evaluated in this study included weight, height, WC, HC, and WHR. The weight and height of the participants were measured using a digital Seca scale (Germany), barefooted with minimum clothing. The BMI was calculated according to the definition of the World Health Organization (WHO) by dividing weight (kg) by the square of height (m). The HC and WC were also measured using a non-stretchable tape to the nearest 1 cm. The WHR was calculated by dividing WC (cm) by HC (cm).
To calculate the sample size, a preliminary study was first conducted on 10 overweight/obese infertile women with PCOS. The mean BMI of the patients was 31.81 kg/m2 with a standard deviation of 2.65. Accordingly, a sample size of 28 was calculated per group for a two sided test at a 5% significance level and 80% power. Finally, an approximate sample size of 39 people per group was calculated by considering a 20% withdrawal or loss to follow-up rate and a 10% adjustment for confounders.
SPSS version 20 was used for statistical analysis. The analysis method was selected to deal with loss to follow-up and missing data. Descriptive tests, independent sample t-test, and Chi-square tests were performed to describe the baseline demographic and reproductive variables of the participants. The participants’ characteristics were investigated to ensure random assignment to the intervention group in this study. If the difference between the two measures of association was 10% or more, confounders were present and adjusted in a multiple regression analysis. Moreover, the effects of health coaching (independent variable) on the primary and secondary outcomes (dependent variables) were assessed using a histogram and a normal probability plot, which showed normally distributed variables. Besides, a multiple regression analysis was performed using the analysis of covariance (ANCOVA) test at a 95% confidence interval (CI) to assess mean differences between the groups in terms of change in scores from the pre-intervention phase (T0) as the dependent variable until four months after the intervention (independent variable). A significance level of 0.05 was considered in all tests.