The Transtheoretical Model For Polycystic Ovary Syndrome

Sponsor

Afyonkarahisar Health Sciences University (Other)

Overall Status

Completed

CT.gov ID

NCT04471012

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Other: Individual counselling program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Impact of The Individual Counseling Program Using The Transtheoretical Model For Polycystic Ovary Syndrome Management Among University Students

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Nov 30, 2016

Actual Study Completion Date :

Nov 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Individual counselling program 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.	Other: Individual counselling program 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.
No Intervention: Standard Care 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.

Arm

Intervention/Treatment

Experimental: Individual counselling program

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.

Other: Individual counselling program

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.

No Intervention: Standard Care

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.

Outcome Measures

Primary Outcome Measures

Anthropometric Measurement [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 24 Years

Sexes Eligible for Study:

Female

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Afyonkarahisar Health Science University	Afyonkarahisar		Turkey	03200

Sponsors and Collaborators

Afyonkarahisar Health Sciences University

Investigators

Principal Investigator: Dilek OCALAN, PhD, Afyonkarahisar Health Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

dilek öcalan, Principal Investigator, Afyonkarahisar Health Sciences University

ClinicalTrials.gov Identifier:

NCT04471012

Other Study ID Numbers:

205-84

First Posted:

Jul 14, 2020

Last Update Posted:

Jul 15, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by dilek öcalan, Principal Investigator, Afyonkarahisar Health Sciences University

transtheoretical model

individual counselling

university students

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Study Results

No Results Posted as of Jul 15, 2020