Motivational Interviewing as an Intervention for Women With Polycystic Ovary Syndrome and BMI Above 30 kg/m2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Weight loss
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with polycystic ovary syndrome and BMI above 30 kg/m2
排除标准
- •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.
结局指标
主要结局
Weight loss
时间窗: 6 months
Measured as change in kg, body mass index and hip to waist circumference
次要结局
- Less symptoms of PCOS(6 months)
- Quality of life(6 months)
研究者
Pernille Ravn
Doktor med.
Odense University Hospital