NCT04471012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

July 10, 2020

Last Update Submit

July 14, 2020

Conditions

Polycystic Ovary Syndrome

Keywords

transtheoretical modelindividual counsellinguniversity students

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    5th month

Study Arms (2)

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.

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.

Interventions

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.

Individual counselling program

Eligibility Criteria

Age19 Years - 24 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Dilek OCALAN, PhD

    Afyonkarahisar Health Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 14, 2020

Study Start

September 1, 2015

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)