Overweight and Obesity Clinical Trial
Official title:
Motivational Interviewing as an Intervention for Women With Polycystic Ovary Syndrome and BMI Above 30 kg/m2
Verified date | October 2016 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight loss | Measured as change in kg, body mass index and hip to waist circumference | 6 months | No |
Secondary | Quality of life | Assessed by questionnaires: WHO five score, major depression index, a VAS score of 10 and a PCOS questionnaire. | 6 months | No |
Secondary | Less symptoms of PCOS | Measured in change in androgen hair growth of body and face, menstruation, acne, pain, hormone levels | 6 months | No |
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