Overweight and Obesity Clinical Trial
Official title:
Motivational Interviewing as an Intervention for Women With Polycystic Ovary Syndrome and BMI Above 30 kg/m2
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):
- 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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