Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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):
Project participants:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Experimental | The women in this group will receive motivational interviews approximately once every 2 weeks for half a year. |
|
| Control | No Intervention | The women in this group will have the usual guidance in weightloss with a booklet on the seven health tips from the danish government. They will not be contacted ind the half year between study onset and finish. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interview | Behavioral | Motivational interview is an interview form based on the patients own thoughts of motivation. It will be conducted by a nurse who is specially trained in this interview type. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Measured as change in kg, body mass index and hip to waist circumference | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Assessed by questionnaires: WHO five score, major depression index, a VAS score of 10 and a PCOS questionnaire. | 6 months |
| Less symptoms of PCOS | Measured in change in androgen hair growth of body and face, menstruation, acne, pain, hormone levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pernille Ravn, MD | Department of Gynocology and obstetrics D, Odense University Hospital | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30182773 | Derived | 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. |
Not provided
Not provided
The plan is to publish the results by the end of 2016. Individual participant data will be available by request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
Not provided
Not provided
| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |