The Transtheoretical Model For Polycystic Ovary Syndrome

NCT ID: NCT04471012

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2016-11-30

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Individual counselling program

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

dilek öcalan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dilek OCALAN, PhD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Science University

Locations

Afyonkarahisar Health Science University

Afyonkarahisar, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

205-84

Identifier Type: -

Identifier Source: org_study_id