Clinical trial NCT02924025: Motivational Interviewing as an Intervention for PCOS
Official title: Motivational Interviewing as an Intervention for Women With Polycystic Ovary Syndrome and BMI Above 30 kg/m2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Overweight and Obesity
Motivation
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 28
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine if motivational interviewing can have a positive effect on weight loss over a 6 month period. By losing weight, the investigators assume the patients will have a positive effect on quality of life, and also that weight loss will help to regulate the factors that are present with polycystic ovary syndrom (PCOS); such as menstrual disorders and infertility.

Participants will be randomly assigned to a treatment group and a control group.

Both groups will be followed as normal with blood samples and other tests such as scans of the ovaries and measurement of height and weight at the beginning of the study and after six months.

In addition, there will be a small hair sample taken from the neck at the first consultation and after 6 months. This is done to measure the stress hormone cortisol in the body over the duration of the experiment.

The treatment group receive individual motivational interviews by a nurse every 14 days for a period of six months. After half a year, tests are repeated to see if there are significant differences between the groups.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight loss
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: 6 months
measure: Less symptoms of PCOS
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gynocology and obstetrics D, Odense University Hospital
name: Pernille Ravn, MD
role: STUDY_CHAIR
References:
citation: Moeller LV, Lindhardt CL, Andersen MS, Glintborg D, Ravn P. Motivational interviewing in obese women with polycystic ovary syndrome - a pilot study. Gynecol Endocrinol. 2019 Jan;35(1):76-80. doi: 10.1080/09513590.2018.1498832. Epub 2018 Sep 5.