Polycystic Ovary SyndromeNCT02924025
Motivational Interviewing as an Intervention for PCOS
A study testing Motivational interview in people with Polycystic Ovary Syndrome and Overweight and Obesity, run by Odense University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Overweight and Obesity, Motivation
- What is being tested?
- Motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with polycystic ovary syndrome and BMI above 30 kg/m2
Who cannot join
- 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.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Motivational interview
- Medical subject headings
- Polycystic Ovary Syndrome, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | The women in this group will receive motivational interviews approximately once every 2 weeks for half a year. Receives: Behavioral: Motivational interview |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured as change in kg, body mass index and hip to waist circumference
Measured: 6 months
Secondary outcomes (2)
Quality of life
Assessed by questionnaires: WHO five score, major depression index, a VAS score of 10 and a PCOS questionnaire.
Measured: 6 months
Less symptoms of PCOS
Measured in change in androgen hair growth of body and face, menstruation, acne, pain, hormone levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pernille Ravn, Odense University Hospital
- Investigators
- Pernille Ravn, MD, Study chair, Department of Gynocology and obstetrics D, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924025
- Sponsor's protocol ID
- Motivational interviewing PCOS
- Status last verified
- Oct 2016
- First submitted
- 25 Sep 2014
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The plan is to publish the results by the end of 2016. Individual participant data will be available by request
Publications
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.
PubMed 30182773
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing as an Intervention for Women With Polycystic Ovary Syndrome and BMI Above 30 kg/m2
- ClinicalTrials.gov ID
- NCT02924025
- Acronym / sponsor ID
- Motivational interviewing PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Behavioral: Motivational interviewThe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women with polycystic ovary syndrome and BMI above 30 kg/m2
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewMotivational 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. | Behavioural | Case |
Primary outcome
Weight loss
Time frame: 6 months
Measured as change in kg, body mass index and hip to waist circumference
2 secondary outcomes
Quality of life
Time frame: 6 months
Less symptoms of PCOS
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 30182773Moeller 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.
- Individual participant dataSharing planned: Yes. The plan is to publish the results by the end of 2016. Individual participant data will be available by request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille Ravn, MD study chair
Department of Gynocology and obstetrics D, Odense University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview in people with Polycystic Ovary Syndrome and Overweight and Obesity, run by Odense University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.