<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471012</url>
  </required_header>
  <id_info>
    <org_study_id>205-84</org_study_id>
    <nct_id>NCT04471012</nct_id>
  </id_info>
  <brief_title>The Transtheoretical Model For Polycystic Ovary Syndrome</brief_title>
  <official_title>Impact of The Individual Counseling Program Using The Transtheoretical Model For Polycystic Ovary Syndrome Management Among University Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Afyonkarahisar Health Sciences University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Afyonkarahisar Health Sciences University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study was to investigate the impact of individual counseling&#xD;
      programs which has been designed from the Transtheoretical Model (TM) suggesting a healthy&#xD;
      diet and physical activity for the students diagnosed with PCOS in the management of their&#xD;
      syndrome. The data for the analysis was drawn from a sample of 854 students at first and a&#xD;
      totally of 67 students were administered the scales. The control (N=33) and experimental&#xD;
      groups (N=34) were formed based on a simple randomization technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anthropometric Measurement</measure>
    <time_frame>1st month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anthropometric Measurement Change</measure>
    <time_frame>3rd month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anthropometric Measurement Change</measure>
    <time_frame>5th month</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>Individual counselling program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
The experimental group was given a Benefits of Healthy Diet and Physical Activity in PCOS Training Booklet during their first counseling session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Individual counselling program</intervention_name>
    <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.&#xD;
Benefits of Healthy Diet and Physical Activity in PCOS Training Booklet was given during their first counseling session.</description>
    <arm_group_label>Individual counselling program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  voluntary participation&#xD;
&#xD;
          -  absence of sexual activity&#xD;
&#xD;
          -  belonging to the age group of 19-24&#xD;
&#xD;
          -  absence of chronic diseases&#xD;
&#xD;
          -  absence of any physical disability and a lack of mental disorders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being on medicine&#xD;
&#xD;
          -  scores of above 18.5 and below 30 on the Body Mass Index (BMI)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dilek OCALAN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Afyonkarahisar Health Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Afyonkarahisar Health Science University</name>
      <address>
        <city>Afyonkarahisar</city>
        <zip>03200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Afyonkarahisar Health Sciences University</investigator_affiliation>
    <investigator_full_name>dilek öcalan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>transtheoretical model</keyword>
  <keyword>individual counselling</keyword>
  <keyword>university students</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471012
org study id: 205-84
nct id: NCT04471012
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Anthropometric Measurement
time frame: 1st month
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.
measure: Anthropometric Measurement Change
time frame: 3rd month
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.
measure: Anthropometric Measurement Change
time frame: 5th month
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.
arm group label: Individual counselling program
arm group type: Experimental
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 group label: Standard Care
arm group type: No Intervention
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: Individual counselling program
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.
arm group label: Individual counselling program
criteria: 
gender: Female
gender based: Yes
minimum age: 19 Years
maximum age: 24 Years
healthy volunteers: No
last name: Dilek OCALAN, PhD
role: Principal Investigator
affiliation: Afyonkarahisar Health Science University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Afyonkarahisar Health Sciences University
investigator full name: dilek öcalan
investigator title: Principal Investigator
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
sharing ipd: No