xml: <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/NCT06004193</url>
    </required_header>
    <id_info>
      <org_study_id>GO 16/307</org_study_id>
      <nct_id>NCT06004193</nct_id>
    </id_info>
    <brief_title>Holiday Season Weight Change During Islamic Holidays</brief_title>
    <official_title>Holiday Season Weight Change During Islamic Holidays and Effect of Exercise on Body Weight and Body Composition</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hacettepe 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 study involved 30 regular exercisers and 33 non-exercisers. Food records were collected&#xD;
        five times: before the holiday season, before Ramadan, during Ramadan, during Ramadan Feast,&#xD;
        and after Ramadan Feast, including the Eid al-Adha period. Anthropometric measurements were&#xD;
        taken before and after holidays: initially before Ramadan and again after Eid al-Adha.&#xD;
        Physical activity was recorded for both groups: once before Ramadan for non-exercisers and&#xD;
        twice (on exercise and rest days) for exercisers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to determine the changes in nutrient consumption during the&#xD;
        holiday season and to assess the changes in body weight, body composition, and blood pressure&#xD;
        of exercising and non-exercising individuals at the end of this season. In the United States&#xD;
        of America, the holiday season is the period between Thanksgiving and New Year's Day. In&#xD;
        Turkey, the holiday season is defined as the period between the Feast of Ramadan and the&#xD;
        Feast of Sacrifice. A total of 30 individuals who regularly exercise and 33 who do not&#xD;
        exercise participated in the study. In this study, 3-day food consumption records were taken&#xD;
        from the participants five times; before the holiday season, before Ramadan, during Ramadan,&#xD;
        during Ramadan Feast, after Ramadan Feast, and during the Eid al-Adha period. The&#xD;
        anthropometric measurements of the participants were measured before and after the holidays.&#xD;
        The first measurement was taken before Ramadan, and the second was taken after Eid al-Adha.&#xD;
        Physical activity was recorded in the pre-Ramadan period, once for non-exercising&#xD;
        participants, and twice for exercising participants, on exercise and rest days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2016</start_date>
    <completion_date type="Actual">March 15, 2017</completion_date>
    <primary_completion_date type="Actual">December 15, 2016</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Body weight</measure>
      <time_frame>4 months</time_frame>
      <description>Body weight measurements</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body fat percentage</measure>
      <time_frame>4 months</time_frame>
      <description>Body fat percentage measured with bioelectrical impedance analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dietary intake</measure>
      <time_frame>4 months</time_frame>
      <description>24-hour dietary recall questionnaires were administered by researchers.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">63</enrollment>
    <condition>Body Weight Changes</condition>
    <arm_group>
      <arm_group_label>Regular Exercisers</arm_group_label>
      <description>The group of regular exercisers includes individuals who engage in at least 150 minutes of exercise per week according to World Health Organization criteria.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-exercisers</arm_group_label>
      <description>The group of non-exercisers includes individuals who do not have a habit of engaging in regular exercise.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>At least 150 minutes of exercise in a week</description>
      <arm_group_label>Regular Exercisers</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants were recruited from a local activity center, which includes a gym as well as&#xD;
          art studios, via bulletin board announcement.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 20 to 45 years&#xD;
  &#xD;
            -  Body mass index (BMI) between 18.5-40.0kg/m2&#xD;
  &#xD;
            -  Observing the Islamic holiday season.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating women&#xD;
  &#xD;
            -  Chronic metabolic diseases including type 1 or type 2 diabetes, any type of cancer,&#xD;
               cardiovascular diseases&#xD;
  &#xD;
            -  5kg of weight gain or loss in the last 3 months&#xD;
  &#xD;
            -  Planning to lose weight or following a specific diet&#xD;
  &#xD;
            -  Exercising &gt;300min/week&#xD;
  &#xD;
            -  Medication use that might affect body weight or composition&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zeynep Goktas, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hacettepe University Nutrition and Dietetics Department</name>
        <address>
          <city>Ankara</city>
          <zip>06100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Zeynep Goktas</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Holiday weight gain</keyword>
    <keyword>Fasting</keyword>
    <keyword>Body composition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Body Weight</mesh_term>
      <mesh_term>Body Weight Changes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004193
  org study id: GO 16/307
  nct id: NCT06004193
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study involved 30 regular exercisers and 33 non-exercisers. Food records were collected
        five times: before the holiday season, before Ramadan, during Ramadan, during Ramadan Feast,
        and after Ramadan Feast, including the Eid al-Adha period. Anthropometric measurements were
        taken before and after holidays: initially before Ramadan and again after Eid al-Adha.
        Physical activity was recorded for both groups: once before Ramadan for non-exercisers and
        twice (on exercise and rest days) for exercisers.
  The purpose of this study is to determine the changes in nutrient consumption during the
        holiday season and to assess the changes in body weight, body composition, and blood pressure
        of exercising and non-exercising individuals at the end of this season. In the United States
        of America, the holiday season is the period between Thanksgiving and New Year's Day. In
        Turkey, the holiday season is defined as the period between the Feast of Ramadan and the
        Feast of Sacrifice. A total of 30 individuals who regularly exercise and 33 who do not
        exercise participated in the study. In this study, 3-day food consumption records were taken
        from the participants five times; before the holiday season, before Ramadan, during Ramadan,
        during Ramadan Feast, after Ramadan Feast, and during the Eid al-Adha period. The
        anthropometric measurements of the participants were measured before and after the holidays.
        The first measurement was taken before Ramadan, and the second was taken after Eid al-Adha.
        Physical activity was recorded in the pre-Ramadan period, once for non-exercising
        participants, and twice for exercising participants, on exercise and rest days.
  observational model: Cohort
  time perspective: Prospective
  measure: Body weight
  time frame: 4 months
  description: Body weight measurements
  measure: Body fat percentage
  time frame: 4 months
  description: Body fat percentage measured with bioelectrical impedance analysis
  measure: Dietary intake
  time frame: 4 months
  description: 24-hour dietary recall questionnaires were administered by researchers.
  arm group label: Regular Exercisers
  description: The group of regular exercisers includes individuals who engage in at least 150 minutes of exercise per week according to World Health Organization criteria.
  arm group label: Non-exercisers
  description: The group of non-exercisers includes individuals who do not have a habit of engaging in regular exercise.
  intervention type: Behavioral
  intervention name: Exercise
  description: At least 150 minutes of exercise in a week
  arm group label: Regular Exercisers
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zeynep Goktas, PhD
  role: Principal Investigator
  affiliation: Hacettepe University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Zeynep Goktas
  investigator title: Principal Investigator
  mesh term: Body Weight
  mesh term: Body Weight Changes
  sharing ipd: No