Motivational Interviewing as an Intervention for PCOS

NCT02924025 | Completed DMC

• 1 other identifier: Motivational interviewing PCOS
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Polycystic Ovary Syndrome; Overweight and Obesity; Motivation

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Measured as change in kg, body mass index and hip to waist circumference

  6 months

Secondary Outcomes (2)

• Quality of life

  6 months

• Less symptoms of PCOS

  6 months

Study Arms (2)

Case

EXPERIMENTAL

The women in this group will receive motivational interviews approximately once every 2 weeks for half a year.

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.

Interventions

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.

Case

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with polycystic ovary syndrome and BMI above 30 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Related Publications (1)

• 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.

  PMID: 30182773 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Overweight; Obesity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pernille Ravn, MD

  Department of Gynocology and obstetrics D, Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doktor med.

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 5, 2016
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share