Motivational Interviewing as an Intervention for PCOS

Main Hypothesis: Overweight women with PCOS receiving motivational interviewing lose at least 1.5 kg more than the control group during the 6 months.

Hypothesis: weight loss leads to positive changes in biochemical parameters, quality of life, and the stress levels assessed by cortisol levels in hair.

Research Plan:

The project began on october 1, 2014 at Odense University Hospital, gynecological and obstetric department. Women referred to the gynecology outpatient clinic for examination of PCOS was examined in the gynecological clinic at the appointment. The women who subsequently are diagnosed with PCOS and have a BMI> 30 kg/m2, who said yes to participation in the trial was randomized to motivational interviews or normal course of treatment.

Both groups: questionnaires and hair samples in both randomized groups. The investigators take about 150 strands of hair of 3 cm length twice in the experiment. Attendance for Biochemistry and objective examinations like the usual procedures for patients with PCOS, ie. this is performed whether the patient is involved in the trial or not. There will be two blood counts during the experiment, one at the start and one at 6 months. Blood sampling is carried out whether the patient is involved in the trial or not. Parameters measured at baseline and after 6 months:

Study program as usual (all patients with PCOS):

• anamneses of menstruation, fertility, use of oral contraceptives, medicine and disease ect.
• anthropometry: height, weight, body mass index (BMI), waist and hip circumference. Blood pressure.
• Biochemistry: fasting blood glucose, HbA1c, insulin, Lutropin hormone (LH), folicle stimulation hormone (FSH), estradiol, free and total testosterone,dehydroepiandrosteron (DHEAS),sex hormon binding globulin (SHBG), prolactin, thyroid stimulating hormone (TSH), 17-OH-progesterone, lipid profile, hemoglobin, 25-OH vitamin D.
• gynecological assessment: Ultrasound scanning of the uterus and ovaries.

Project participants:

• Questionnaires; SF-36, VAS score, major depression score (MDI), the world health organization WHO-five well-being index.
• hair sample for the detection of cortisol

Practical course:

First examination in the clinic: If the patient meets the inclusion criteria an in-depth information about the trial is given. If the patient wants to participate, the patient is issued a written statement of consent and is pre booked an appointment with a nurse At the first visit to the nurse: the consent form is signed, if wish for participation in the study is maintained the patient is randomized. The patient fill out questionnaires and a hair sample is taken. All patients are provided with information on weight loss from the Health Protection Agency advice about diet and exercise as above. Patients who are randomized to motivational interviews starts a course of interviews. Participant data is imported into a spreadsheet for later determination.

Intervention: appointments of interview are scheduled individually, but should be around one interview every 14 days of about 20 minutes.

After 6 months, all patients are examined again as mentioned above as part of the usual control of PCOS.

Inclusion criteria

• Women with polycystic ovary syndrome and BMI above 30 kg/m2

Exclusion criteria

• Women taking gender hormone medication, for example birthcontrol pills.
• Metformin treatment in less than 3 months (i.e. women who is in a stable treatment and have been taking metformin in more than 3 months, is allowed to participate)
• women who can not read/understand danish, and is in need of a translater.