<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/NCT04401930</url>
  </required_header>
  <id_info>
    <org_study_id>13052020</org_study_id>
    <secondary_id>CUP E47F17000020009</secondary_id>
    <nct_id>NCT04401930</nct_id>
  </id_info>
  <brief_title>Eating Habits and Lifestyle Profile of an Italian Aging Cohort</brief_title>
  <official_title>Eating Habits and Lifestyle Profile of an Italian Aging Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pavia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Milano Bicocca</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pavia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aging is characterized by low-grade inflammatory state, supported by impairment oxidative&#xD;
      balance and endocrine changes, leading to changes in: body composition, such as decrease in&#xD;
      lean body mass and increase in adipose tissue; resting metabolic rate; immune function;&#xD;
      cognitive impairment. According to the Academy of Nutrition and Dietetics all subjects over&#xD;
      the age of 60 should be able to access to adequate nutrition and appropriate nutritional&#xD;
      services.&#xD;
&#xD;
      In order to ensure healthy aging and to reduce effects of specific diseases, recommendations&#xD;
      are needed for illness and disability in this population, as well as adequate physical&#xD;
      activity and specific support programs, culturally accepted.&#xD;
&#xD;
      The aim of this study is to evaluate eating habits in term of food consumption, health state&#xD;
      and lifestyle in a sample of free-living elderly over the age of 65, living in Milan and&#xD;
      surroundings.&#xD;
&#xD;
      In particular, profiling of the elderly population is performed using a survey in which&#xD;
      information are collected on methods, contexts, time and ability to buy, prepare, consume and&#xD;
      dispose of and recycle food. Eating habits and knowledge about food are detected through the&#xD;
      analysis of food consumption frequencies, and lifestyle by assessing the level of physical&#xD;
      activity, quality of sleep, smoking habit. Weight status and health status are evaluated&#xD;
      through anthropometric measurements, body composition (bioelectrical impedance) and strength&#xD;
      test.&#xD;
&#xD;
      Other information relating to social participation and other socio-demographic variables&#xD;
      (age, gender, family composition, socio-economic status) are collected to have a completed&#xD;
      profiling of target population.&#xD;
&#xD;
      Achieved results will help us to identify factors on which acting to ensure healthy aging and&#xD;
      counteract inflammaging, the chronic low-grade systemic inflammation characteristic in the&#xD;
      aging process.&#xD;
&#xD;
      Moreover, the study allows increasing the knowledge related to the needs and requirements of&#xD;
      the target population to determine a good food policy and to increase the elderly&#xD;
      empowerment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study concerns the elderly population of the Milan Metropolitan Area. The aim is to&#xD;
      identify and interpret the nutritional needs of the target population and thus implement the&#xD;
      quality of life and the nutritional status of citizens through the evaluation of the dietary&#xD;
      habits, health status and lifestyle of the elderly free-living.&#xD;
&#xD;
      The information is collected through a questionnaire consisting of 6 sections and includes&#xD;
      batteries of questions and scales already validated in the literature: i) access to the&#xD;
      points of sale; ii) consumer behavior; iii) eating habits; iv) opinions regarding&#xD;
      accessibility; v) state of health, physical activity and sleep quality; vi) other&#xD;
      socio-demographic information. The collected data will allow to identify different profiles&#xD;
      of elderly people with respect to the investigated dimensions and to estimate the influence&#xD;
      of different factors on eating habits and health status.&#xD;
&#xD;
      To complete the information collected with the questionnaire, functional and anthropmetric&#xD;
      parameters are detected which are useful to complete the nutritional assessment of the target&#xD;
      population. Specifically, the muscle strength, body composition, body weight, height, body&#xD;
      circumferences, plicometry are measured, and the antripometric indices waist-height&#xD;
      circumference ratio, waist-hip circumference ratio and arm muscle area are calculated.&#xD;
&#xD;
      SAMPLE SIZE: Based on the data on the population residing on 1 January 2017 from an Istat&#xD;
      source, the residents of the metropolitan city of Milan aged 65 and over are 722703. The&#xD;
      sample size was defined with the choice of a confidence level of 95% and of a confidence&#xD;
      interval of 4%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the socio-demographic characteristics</measure>
    <time_frame>1 day</time_frame>
    <description>Age, Educational level, family status, food safety, food security.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of eating habits</measure>
    <time_frame>1 day</time_frame>
    <description>Eating habits: evaluated with the Food Habit (FHQ) section of questionnaire by Turconi et al. (2003), to investigate the eating habits related to daily number of meals, consumption of the main food groups (fruit, vegetables, etc) and soft drinks or alcoholic beverages. Each question has the following response: always, often, sometimes, never. The score assigned to each response ranged from 0 to 3, with the maximum score assigned to the healthiest one and the minimum score to the least healthy one according to the Italian National Dietary Guidelines (2018).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of smoking habits</measure>
    <time_frame>1 day</time_frame>
    <description>Smoking habits: evaluated with specific semi-quantitative questions such as: &quot;Are you smoker, no-smoker or former smoker?&quot;; &quot;How long have you been smoking?&quot;, &quot;How old were you when you started smoking?&quot; and &quot;How many cigarettes do you smoke daily?&quot; in current smokers; &quot;How many years have passed since the last cigarette?&quot; and &quot;How many cigarettes per day did you use to smoke?&quot; in former smokers. The minimum score was assigned to the healthiest habit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Physical activity level</measure>
    <time_frame>1 day</time_frame>
    <description>Physical activity level evaluated with the International Physical Activity Questionnaires (IPAQ) - Short Form. The specific activity levels assessed are walking, moderate-intensity activities and vigorous-intensity activities. The scores are expressed in Metabolic Equivalent of task -minutes/week.The total score includes the sum of the duration (in minutes) and the frequency (days) of the three dimensions analyzed (walking, activity of moderate intensity and vigorous intensity). Higher number of MET per week relate with higher level of physical activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Sleep Quality</measure>
    <time_frame>1 day</time_frame>
    <description>Sleep Quality: evaluated with the Italian version of Pittsburgh Sleep Quality Index (PSQI), validated by Curcio et al (2011). It's a 19-item questionnaire investigating seven domains of sleep (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction). A global score, calculated from the score of each domains, higher than 5 is considered as an indicator of bad sleep quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutritional assessment: weight status</measure>
    <time_frame>1 day</time_frame>
    <description>Measurement of: body weight in kilograms; height in centimeters, evaluated with prediction formula height-knee by Donini et al (2000); weight and height will be combined to report BMI in kg/m^2 to evaluate the weight status (underweight, normal, overweight, obesity);</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutritional assessment: fat distribution</measure>
    <time_frame>1 day</time_frame>
    <description>Measurement of: waist circumference in centimeters; hip circumference in centimeters; waist and hip will be combined to report waist-hip ratio (WHR) and waist and height will be combined to report waist-height ratio (WHtR), both as indicators of fat distribution and metabolic diseases risk.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutritional assessment: other antropometric parameters</measure>
    <time_frame>1 day</time_frame>
    <description>Measurement of calf circumference in centimeters, as inidcator of muscle mass. Measurement of neck circumference in centimeters, as indicator of fat distribution and metabolic diseases risk.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutritional assessment: arm circumference and triceps skinfold thickness</measure>
    <time_frame>1 day</time_frame>
    <description>Mesurement of: arm circumference in centimeters, as inidcator of muscle mass; triceps skinfold thickness in millimeters, as indicator of fatty mass; upper arm circumference and triceps fold will be combined to report the upper arm area in millimeters^2, upper arm muscle area in millimeters^2, upper arm fat area in millimeters^2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutritional assessment: muscle strenght</measure>
    <time_frame>1 day</time_frame>
    <description>Measurement of hand-grip in kilograms, to assess muscle strength</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutritional assessment: body composition</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of body composition with bioelectrical impedance analysis (BIVA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to Italian National Dietary Guidelines</measure>
    <time_frame>1 day</time_frame>
    <description>Assess adherence to adequate eating habits from the analysis of Food Habits questionnaire according to the Italian National Dietary Guidelines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify possible nutritional deficiencies</measure>
    <time_frame>1 day</time_frame>
    <description>Identify possible nutritional deficiencies from the analysis of the Food Habits questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifestyle and nutritional status</measure>
    <time_frame>1 day</time_frame>
    <description>Influence of eating habits analyzed with FHQ, sleep quality analyzed with PSQI, and physical activity level analyzed with IPAQ on nutritional status (all antropometric and body composition parameters collected).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>Aging</condition>
  <condition>Healthy Aging</condition>
  <condition>Life Style</condition>
  <condition>Eating Habit</condition>
  <condition>Nutritional Deficiency</condition>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Free-living elderly</arm_group_label>
    <description>Free-living elderly over the age of 65 living in Metropolitan Area of Milan, in apparent good health conditions.&#xD;
Male and Female</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Free-living over 65 subjects living in Milan and surroundings, in apparent good health&#xD;
        conditions and self sufficient, able to express their consent to participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: over 65&#xD;
&#xD;
          -  free-living&#xD;
&#xD;
          -  autonomous, self sufficient&#xD;
&#xD;
          -  acceptance and sign of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age: under 65&#xD;
&#xD;
          -  living in: nursing home, Extended Care&#xD;
&#xD;
          -  hospitalized&#xD;
&#xD;
          -  non autonomous, non self sufficient&#xD;
&#xD;
          -  without acceptance and sign of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hellas Cena</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pavia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pavia</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 28, 2021</last_update_submitted>
  <last_update_submitted_qc>May 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pavia</investigator_affiliation>
    <investigator_full_name>Hellas Cena</investigator_full_name>
    <investigator_title>Tenured researcher</investigator_title>
  </responsible_party>
  <keyword>elderly</keyword>
  <keyword>life style</keyword>
  <keyword>eating habits</keyword>
  <keyword>health status</keyword>
  <keyword>body composition</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>nutritional deficiency</keyword>
  <keyword>aged</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- 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/NCT04401930
org study id: 13052020
secondary id: CUP E47F17000020009
nct id: NCT04401930
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Aging is characterized by low-grade inflammatory state, supported by impairment oxidative
      balance and endocrine changes, leading to changes in: body composition, such as decrease in
      lean body mass and increase in adipose tissue; resting metabolic rate; immune function;
      cognitive impairment. According to the Academy of Nutrition and Dietetics all subjects over
      the age of 60 should be able to access to adequate nutrition and appropriate nutritional
      services.

      In order to ensure healthy aging and to reduce effects of specific diseases, recommendations
      are needed for illness and disability in this population, as well as adequate physical
      activity and specific support programs, culturally accepted.

      The aim of this study is to evaluate eating habits in term of food consumption, health state
      and lifestyle in a sample of free-living elderly over the age of 65, living in Milan and
      surroundings.

      In particular, profiling of the elderly population is performed using a survey in which
      information are collected on methods, contexts, time and ability to buy, prepare, consume and
      dispose of and recycle food. Eating habits and knowledge about food are detected through the
      analysis of food consumption frequencies, and lifestyle by assessing the level of physical
      activity, quality of sleep, smoking habit. Weight status and health status are evaluated
      through anthropometric measurements, body composition (bioelectrical impedance) and strength
      test.

      Other information relating to social participation and other socio-demographic variables
      (age, gender, family composition, socio-economic status) are collected to have a completed
      profiling of target population.

      Achieved results will help us to identify factors on which acting to ensure healthy aging and
      counteract inflammaging, the chronic low-grade systemic inflammation characteristic in the
      aging process.

      Moreover, the study allows increasing the knowledge related to the needs and requirements of
      the target population to determine a good food policy and to increase the elderly
      empowerment.
The study concerns the elderly population of the Milan Metropolitan Area. The aim is to
      identify and interpret the nutritional needs of the target population and thus implement the
      quality of life and the nutritional status of citizens through the evaluation of the dietary
      habits, health status and lifestyle of the elderly free-living.

      The information is collected through a questionnaire consisting of 6 sections and includes
      batteries of questions and scales already validated in the literature: i) access to the
      points of sale; ii) consumer behavior; iii) eating habits; iv) opinions regarding
      accessibility; v) state of health, physical activity and sleep quality; vi) other
      socio-demographic information. The collected data will allow to identify different profiles
      of elderly people with respect to the investigated dimensions and to estimate the influence
      of different factors on eating habits and health status.

      To complete the information collected with the questionnaire, functional and anthropmetric
      parameters are detected which are useful to complete the nutritional assessment of the target
      population. Specifically, the muscle strength, body composition, body weight, height, body
      circumferences, plicometry are measured, and the antripometric indices waist-height
      circumference ratio, waist-hip circumference ratio and arm muscle area are calculated.

      SAMPLE SIZE: Based on the data on the population residing on 1 January 2017 from an Istat
      source, the residents of the metropolitan city of Milan aged 65 and over are 722703. The
      sample size was defined with the choice of a confidence level of 95% and of a confidence
      interval of 4%.
observational model: Cohort
time perspective: Cross-Sectional
measure: Assessment of the socio-demographic characteristics
time frame: 1 day
description: Age, Educational level, family status, food safety, food security.
measure: Assessment of eating habits
time frame: 1 day
description: Eating habits: evaluated with the Food Habit (FHQ) section of questionnaire by Turconi et al. (2003), to investigate the eating habits related to daily number of meals, consumption of the main food groups (fruit, vegetables, etc) and soft drinks or alcoholic beverages. Each question has the following response: always, often, sometimes, never. The score assigned to each response ranged from 0 to 3, with the maximum score assigned to the healthiest one and the minimum score to the least healthy one according to the Italian National Dietary Guidelines (2018).
measure: Assessment of smoking habits
time frame: 1 day
description: Smoking habits: evaluated with specific semi-quantitative questions such as: "Are you smoker, no-smoker or former smoker?"; "How long have you been smoking?", "How old were you when you started smoking?" and "How many cigarettes do you smoke daily?" in current smokers; "How many years have passed since the last cigarette?" and "How many cigarettes per day did you use to smoke?" in former smokers. The minimum score was assigned to the healthiest habit.
measure: Assessment of Physical activity level
time frame: 1 day
description: Physical activity level evaluated with the International Physical Activity Questionnaires (IPAQ) - Short Form. The specific activity levels assessed are walking, moderate-intensity activities and vigorous-intensity activities. The scores are expressed in Metabolic Equivalent of task -minutes/week.The total score includes the sum of the duration (in minutes) and the frequency (days) of the three dimensions analyzed (walking, activity of moderate intensity and vigorous intensity). Higher number of MET per week relate with higher level of physical activity.
measure: Assessment of Sleep Quality
time frame: 1 day
description: Sleep Quality: evaluated with the Italian version of Pittsburgh Sleep Quality Index (PSQI), validated by Curcio et al (2011). It's a 19-item questionnaire investigating seven domains of sleep (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction). A global score, calculated from the score of each domains, higher than 5 is considered as an indicator of bad sleep quality.
measure: Nutritional assessment: weight status
time frame: 1 day
description: Measurement of: body weight in kilograms; height in centimeters, evaluated with prediction formula height-knee by Donini et al (2000); weight and height will be combined to report BMI in kg/m^2 to evaluate the weight status (underweight, normal, overweight, obesity);
measure: Nutritional assessment: fat distribution
time frame: 1 day
description: Measurement of: waist circumference in centimeters; hip circumference in centimeters; waist and hip will be combined to report waist-hip ratio (WHR) and waist and height will be combined to report waist-height ratio (WHtR), both as indicators of fat distribution and metabolic diseases risk.
measure: Nutritional assessment: other antropometric parameters
time frame: 1 day
description: Measurement of calf circumference in centimeters, as inidcator of muscle mass. Measurement of neck circumference in centimeters, as indicator of fat distribution and metabolic diseases risk.
measure: Nutritional assessment: arm circumference and triceps skinfold thickness
time frame: 1 day
description: Mesurement of: arm circumference in centimeters, as inidcator of muscle mass; triceps skinfold thickness in millimeters, as indicator of fatty mass; upper arm circumference and triceps fold will be combined to report the upper arm area in millimeters^2, upper arm muscle area in millimeters^2, upper arm fat area in millimeters^2.
measure: Nutritional assessment: muscle strenght
time frame: 1 day
description: Measurement of hand-grip in kilograms, to assess muscle strength
measure: Nutritional assessment: body composition
time frame: 1 day
description: Assessment of body composition with bioelectrical impedance analysis (BIVA).
measure: Adherence to Italian National Dietary Guidelines
time frame: 1 day
description: Assess adherence to adequate eating habits from the analysis of Food Habits questionnaire according to the Italian National Dietary Guidelines.
measure: Identify possible nutritional deficiencies
time frame: 1 day
description: Identify possible nutritional deficiencies from the analysis of the Food Habits questionnaire
measure: Lifestyle and nutritional status
time frame: 1 day
description: Influence of eating habits analyzed with FHQ, sleep quality analyzed with PSQI, and physical activity level analyzed with IPAQ on nutritional status (all antropometric and body composition parameters collected).
arm group label: Free-living elderly
description: Free-living elderly over the age of 65 living in Metropolitan Area of Milan, in apparent good health conditions.
Male and Female
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hellas Cena
role: Principal Investigator
affiliation: University of Pavia
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Pavia
investigator full name: Hellas Cena
investigator title: Tenured researcher
mesh term: Sarcopenia
mesh term: Malnutrition