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The Transtheoretical Model For Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Individual counselling program
Sponsored by
Afyonkarahisar Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Polycystic Ovary Syndrome focused on measuring transtheoretical model, individual counselling, university students

Eligibility Criteria

19 Years - 24 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • being on medicine
  • scores of above 18.5 and below 30 on the Body Mass Index (BMI)

Sites / Locations

  • Afyonkarahisar Health Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Individual counselling program

Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2020
Last Updated
July 14, 2020
Sponsor
Afyonkarahisar Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT04471012
Brief Title
The Transtheoretical Model For Polycystic Ovary Syndrome
Official Title
Impact of The Individual Counseling Program Using The Transtheoretical Model For Polycystic Ovary Syndrome Management Among University Students
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyonkarahisar Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
transtheoretical model, individual counselling, university students

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual counselling program
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Individual counselling program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anthropometric Measurement
Description
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.
Time Frame
1st month
Title
Anthropometric Measurement Change
Description
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.
Time Frame
3rd month
Title
Anthropometric Measurement Change
Description
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.
Time Frame
5th month

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: being on medicine scores of above 18.5 and below 30 on the Body Mass Index (BMI)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek OCALAN, PhD
Organizational Affiliation
Afyonkarahisar Health Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Afyonkarahisar Health Science University
City
Afyonkarahisar
ZIP/Postal Code
03200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Transtheoretical Model For Polycystic Ovary Syndrome

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