Participants in the active group received the 'pharmacist standard counseling' plus the 'pharmaceutical care service' designed by the research group. Both services were delivered by one female clinical pharmacist who has a Master's degree in pharmaceutical sciences, 5-year work experience in community pharmacies, and comprehensive knowledge of PCOS. The time it took to deliver the counseling and education to each participant in the active group was formally assessed. This time assessment excluded data collection and questionnaire filling time (which was planned to take around 15 min).
Participants in the active group received the usual care delivered at the community pharmacies plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise.

Participants in the control group received the usual care only which is the 'pharmacist standard counseling' involved dispensing the prescribed medication (delivered by the pharmacist in charge), counseling on how to take the dispensed medications, and a brief reply to questions if asked by the participants. The 'pharmacist standard counseling' followed what was normally delivered to females with PCOS by pharmacists working at community pharmacies in both countries. This 'pharmacist standard counseling' was established based on what was observed and reported by the project research team after viewing the usual pharmacists' interaction with females with PCOS for two weeks in each country before the start of the study.
Participants in the control group were informed that the educational intervention (the pharmaceutical care service) will be delivered to them after the end of the study (for ethical reasons).

Participants in the active group received the usual care delivered at the community pharmacies plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise.

Polycystic Ovary Syndrome

The intervention was provided in the format of oral plus written information. The information provided included the importance of exercise and motivational messages to exercise more at home or in the gym.
The 2nd part was about the importance of decreasing the stress levels. Participants were informed to perform a simple breathing exercise on daily basis twice a day.
The 3rd part aimed at improving participants' diets. They were informed to follow specific diet recommendations and to avoid certain types of food, explaining to them how it may negatively affect their PCOS condition.
The 4th part was about the PCOS treatment that was discussed with the participants. Females were advised on the importance of using their correct treatment. They were informed of the importance of adhering to their prescribed medications, accepting that it was a long-term treatment plan, and to consult with their specialist if their treatment was not effective, or in the case of medication side effects.

The PCOS pharmaceutical care service

Five branches of Pharmacy 1

Almazra pharmacy

Alwafaa pharmacy

Kinda Pharmacy

The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome

The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome Associated Factors Amongst Females in Jordan and Syria

Anxiety prevalence assessment using the Beck Anxiety Inventory. The BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms.

Depression prevalence assessment using the Beck Depression Inventory. The BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms.

Levels of Anxiety severity and mean score assessment were done by the Beck Anxiety Inventory.
The BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms.

Levels of Depression severity and mean score assessment were done by the Beck Depression Inventory.
The BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms.

Quality of Life assessment using the polycystic ovary syndrome health-related QOL questionnaire (PCOSQ).
It has a 30 questions about symptoms related to menstruation and mood. It can identify seven factors affecting the QOL in PCOS women including: emotional disturbance, hirsutism, weight concerns, infertility, menstrual symptoms, menstrual predictability and acne. The QOL was analyzed individually as a continuous scale out of seven to assess the QOL in patients (the higher the score is, the better the QOL is). After that, each question of the 30 questions included in the PCOSQ questionnaire was analyzed, and the mean score within each question was obtained and compared between baseline and follow-up. After that, each domain included in the QOL questionnaire was analyzed individually. Mean score of each domain was obtained and compared between baseline and follow-u to assess the impact of lifestyle modifications on that domain.

Systolic and diastolic blood pressure measurements were measured using the right arm, twice after a 10-min rest and averaged by using the gold standard, mercury sphygmomanometers

Blood Glucose levels assessment using the Multi-parametric device.

Blood Cholesterol levels assessment using the Multi-parametric device.

Blood Triglycerides levels assessment using the Multi-parametric device.

the Body Mass Index was calculated for each participant depending on their weight and hight.

smokers participants recorded the number of cigarettes smoked per day.

Applied Science Private University

Participants in the active group received the usual care delivered at the community pharmacies at both countries plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist, an experienced female with extensive knowledge on PCOS. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise. Participants in the control group received the usual care only and did not receive the pharmaceutical care service.
Following the intervention, both groups were followed up for four months and re-interviewed at the community pharmacy.

The study is a single-blinded randomized controlled trial. The patients 'study groups were only known for the clinical pharmacist.

Participants will eat fatty fish and avoiding nuts)

Participants who will avoid both fatty fish and nuts

Obesity

Metabolic Syndrome

Diabetes

At inclusion demographic information recorded, including length of breastfeeding for women. Thereafter, participants will start with a run-in period of two weeks where they will be asked not to consume salmon, mackerel, sardines or other fatty fish or nuts providing a dietary baseline. At baseline, subjects will be randomized to a fish, nuts or control group. The fish group will be asked to consume three to four portions weekly. The fish will be eaten at the main meal and in sandwiches for a total of 600 grams weekly for 6 months. This group will avoid eating nuts. The nut group will consume equal amount of energy (~1400 kcal ) for weekly use for 6 months. This group will avoid eating fatty fish. The control group will consume their usual diet, but asked to avoid fatty fish and nuts.

The fatty fish group

At baseline (conditions for baseline are the same in all three groups) the nut group will consume equal amount of energy (~1400 kcal ~100 grams walnuts, ~50 grams hazelnuts and ~50 grams almonds/week).The nuts will be provided free of charge for the six months. This group will avoid eating fatty fish.

The nut group

After the baseline the control group will consume their usual diet, asked to avoid fatty fish and nuts.

The control group

Oslo University Hospital, Ullevål

Fish or Nuts? Dietary Effects on Cardiometabolic Risk Factors and Persistent Organic Pollutants

Measuring of persistent organic pollutants' levels before and after intervention.
Blood tests will be obtained at randomization, and six months of follow-up for analysis analysis of environmental pollutants including 21 POPs in g/mol .Six-month follow-up samples will be stored for future analyses.

waist circumference in cm as cardiometabolic risk factor

Secondary endpoints will include C-reactive protein

The HOMA index (The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function) in % will be calculated

juglans mollis/insult

The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome

Fish or Nuts? Dietary Effects on Cardiometabolic Risk Factors and Persistent Organic Pollutants

Effects of California Walnuts on Vascular Function in Postmenopausal Women

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