Polycystic Ovary SyndromeNCT04471012
The Transtheoretical Model For Polycystic Ovary Syndrome
A study testing Individual counselling program in people with Polycystic Ovary Syndrome, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The main objective of this study was to investigate the impact of individual counseling programs which has been designed from the Transtheoretical Model (TM) suggesting a healthy diet and physical activity for the students diagnosed with PCOS in the management of their syndrome. Read more about this study
- Who is it for?
- Ages 19 to 24 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Individual counselling program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2015to 30 Nov 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 19 to 24 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- voluntary participation
- absence of sexual activity
- belonging to the age group of 19-24
- absence of chronic diseases
- absence of any physical disability and a lack of mental disorders.
Who cannot join
- being on medicine
- scores of above 18.5 and below 30 on the Body Mass Index (BMI)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar, 03200
About this study
Official title: Impact of The Individual Counseling Program Using The Transtheoretical Model For Polycystic Ovary Syndrome Management Among University Students
The main objective of this study was to investigate the impact of individual counseling programs which has been designed from the Transtheoretical Model (TM) suggesting a healthy diet and physical activity for the students diagnosed with PCOS in the management of their syndrome. The data for the analysis was drawn from a sample of 854 students at first and a totally of 67 students were administered the scales. The control (N=33) and experimental groups (N=34) were formed based on a simple randomization technique.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Individual counselling program
- Keywords
- transtheoretical model, individual counselling, university students
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual counselling programOther
An individual counseling program that was based on TM and included motivational interview techniques was given to the experimental group which involved general information about the importance of weight control, healthy diet, and exercise.
Benefits of Healthy Diet and Physical Activity in PCOS Training Booklet was given during their first counseling session.
| Study group | Role | What they receive |
|---|---|---|
| Individual counselling program | Experimental | An individual counseling program that was based on TM and included motivational interview techniques was given to the experimental group which involved general information about the importance of weight control, healthy diet, and exercise.
The experimental group was given a Benefits of Healthy Diet and Physical Activity in PCOS Training Booklet during their first counseling session. Receives: Other: Individual counselling program |
| Standard Care | No intervention | The progress of the participants in the control group was tracked routinely without any specific implementation. At the end of the study, the control group was also given the same booklet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric Measurement
Anthropometric measurements that are frequently used to evaluate the nutritional status of the individuals are weight and height will be combined to report BMI in kg/m2.
Measured: 1st month
Anthropometric Measurement Change
Anthropometric measurements that are frequently used to evaluate the nutritional status of the individuals are weight and height will be combined to report BMI in kg/m2.
Measured: 3rd month
Anthropometric Measurement Change
Anthropometric measurements that are frequently used to evaluate the nutritional status of the individuals are weight and height will be combined to report BMI in kg/m2.
Measured: 5th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Sep 2015
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dilek öcalan, Afyonkarahisar Health Sciences University
- Investigators
- Dilek OCALAN, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471012
- Sponsor's protocol ID
- 205-84
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of The Individual Counseling Program Using The Transtheoretical Model For Polycystic Ovary Syndrome Management Among University Students
- ClinicalTrials.gov ID
- NCT04471012
- Acronym / sponsor ID
- 205-84
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- transtheoretical model, individual counselling, university students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 14 Jul 2020 (actual)
- 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 main objective of this study was to investigate the impact of individual counseling programs which has been designed from the Transtheoretical Model (TM) suggesting a healthy diet and physical activity for the students diagnosed with PCOS in the management of their syndrome. The data for the analysis was drawn from a sample of 854 students at first and a totally of 67 students were administered the scales. The control (N=33) and experimental groups (N=34) were formed based on a simple randomization technique.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual counselling program | Experimental | Other: Individual counselling programAn individual counseling program that was based on TM and included motivational interview techniques was given to the experimental group which involved general information about the importance of weight control, healthy diet, and exercise. The experimental group was given a Benefits of Healthy Diet and Physical Activity in PCOS Training Booklet during their first counseling session. |
| Standard Care | No intervention | –The progress of the participants in the control group was tracked routinely without any specific implementation. At the end of the study, the control group was also given the same booklet. |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- voluntary participation
- absence of sexual activity
- belonging to the age group of 19-24
- absence of chronic diseases
- absence of any physical disability and a lack of mental disorders.
Key exclusion criteria (2 listed)
- being on medicine
- scores of above 18.5 and below 30 on the Body Mass Index (BMI)
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 |
|---|---|---|
| Individual counselling programAn individual counseling program that was based on TM and included motivational interview techniques was given to the experimental group which involved general information about the importance of weight control, healthy diet, and exercise. Benefits of Healthy Diet and Physical Activity in PCOS Training Booklet was given during their first counseling session. | Other | Individual counselling program |
Primary outcome
Anthropometric Measurement
Time frame: 1st month
Anthropometric measurements that are frequently used to evaluate the nutritional status of the individuals are weight and height will be combined to report BMI in kg/m2.
Anthropometric Measurement Change
Time frame: 3rd month
Anthropometric measurements that are frequently used to evaluate the nutritional status of the individuals are weight and height will be combined to report BMI in kg/m2.
Anthropometric Measurement Change
Time frame: 5th month
Anthropometric measurements that are frequently used to evaluate the nutritional status of the individuals are weight and height will be combined to report BMI in kg/m2.
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 15 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Dilek OCALAN, PhD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual counselling program in people with Polycystic Ovary Syndrome, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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 5 inclusion and 2 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 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Anthropometric Measurement (time frame: 1st month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2020.