<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/NCT01674296</url>
  </required_header>
  <id_info>
    <org_study_id>GFHNRC018</org_study_id>
    <nct_id>NCT01674296</nct_id>
  </id_info>
  <brief_title>Seasonal Patterns of Stress, Diet and Physical Activity - Life in All Seasons (LENAS)</brief_title>
  <acronym>LENAS</acronym>
  <official_title>Seasonality of Stress, Diet, and Physical Activity in Mid-Life Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA Grand Forks Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA Grand Forks Human Nutrition Research Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to develop a better understanding of factors affecting&#xD;
      American's energy balance related behaviors - in this case, food intake and activity. In the&#xD;
      present study we will describe the relative contributions of individual psychology and&#xD;
      physiology (including metabolism, mood, and sleep habits) and external (season, stressors)&#xD;
      contributions to changes in adiposity over a year in free-living individuals.&#xD;
&#xD;
      This study will illuminate season's role in changes in energy balance related behaviors and&#xD;
      body weight and composition. Ultimately, this information will be used to identify factors&#xD;
      affecting food consumption and individual activity during seasonal periods to help to segment&#xD;
      interventions for obesity prevention in mid-life women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a longitudinal, observational study of mid-life women spanning one year.There will be&#xD;
      frequent monitoring of food consumption, individual activity and individual- level factors&#xD;
      thought to influence food consumption and activity such as dietary restraint, subjective&#xD;
      stress, sleep quality and duration, and physiological stress as measured by allostatic load.&#xD;
&#xD;
      Specific aims:&#xD;
&#xD;
        1. To identify seasonal changes in %BF of mid-life women.&#xD;
&#xD;
           Participant's percentage of body fat will fluctuate, and will be highest at the end of&#xD;
           the winter season and lowest at the end of the summer season.&#xD;
&#xD;
        2. To describe predictors of seasonal changes in %BF.&#xD;
&#xD;
      There will be no intervention other than frequent monitoring of food consumption, individual&#xD;
      activity and individual- level factors thought to influence food consumption and activity&#xD;
      such as dietary restraint, subjective stress, sleep quality and duration, and physiological&#xD;
      stress as measured by allostatic load. The volunteers will be asked to complete a 7-day&#xD;
      activity and energy expenditure monitoring period (along with body composition assessment,&#xD;
      questionnaires regarding individual factors thought to affect food consumption and activity,&#xD;
      blood draw and urine collection to measure allostatic load) in each of the four seasons over&#xD;
      a 12-month period; between monitoring periods they will come to the GFHNRC for measurement of&#xD;
      weight, skin carotenoids for assessment of fruit and vegetable intake, and to provide a&#xD;
      morning urine sample monthly (8 times), and receive emails reminding them to log on to a&#xD;
      secure server and complete a 24-hr recall 3 times a month (36 times during the year).&#xD;
&#xD;
      The ASA-24 will be administered to assess nutritional intake; Actigraph GT3X+, Actitrainer,&#xD;
      and QStarz GPS logger will be used to assess physical activity. Physiological stress will be&#xD;
      assessed using the allostatic load index.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Change in body fat</measure>
    <time_frame>Season 1, season 2, season 3, season 4</time_frame>
    <description>Body fat location and amount will be assess by dual-energy X-ray absorptiometry</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Obesity</condition>
  <condition>Stress</condition>
  <condition>Feeding Behavior</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Group 1 (2012-2013)</arm_group_label>
    <description>Monitoring of Dietary Intake, Physical Activity and Stress</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (2013-2014)</arm_group_label>
    <description>Monitoring of Dietary Intake, Physical Activity and Stress</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, Plasma, Buffy Coat, Urine, Saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Middle-aged females&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ambulatory women aged 40-60 years&#xD;
&#xD;
          -  Weight stable (±10 lbs) for at least 6 months prior to the start of the study&#xD;
&#xD;
          -  Body mass index (BMI) between 18-35 kg/m2&#xD;
&#xD;
          -  Access to high-speed internet&#xD;
&#xD;
          -  Willing to comply with study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;35 or &lt; 18&#xD;
&#xD;
          -  Current smoker or tobacco or nicotine use&#xD;
&#xD;
          -  Male sex&#xD;
&#xD;
          -  Age &lt;40.0 or &gt;60 years&#xD;
&#xD;
          -  Health conditions (cardiovascular, pulmonary, orthopedic, asthma) that would limit&#xD;
             participation in physical activity&#xD;
&#xD;
          -  Medications that would influence appetite, weight gain or weight loss.&#xD;
&#xD;
          -  Intentional changes in diet or large increases in physical activity for the purpose of&#xD;
             weight loss during the study. Typical weight maintenance behaviors are not an&#xD;
             exclusion criterion.&#xD;
&#xD;
          -  Pregnant, lactating, or planning pregnancy.&#xD;
&#xD;
          -  Travel plans that do not permit full participation.&#xD;
&#xD;
          -  Inability to walk without assistance. The capability to walk upright is fundamental&#xD;
             because accelerometry measures the duration and intensity of horizontal physical&#xD;
             activities.&#xD;
&#xD;
          -  Inability to give consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Roemmich, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA-ARS-GFHNRC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grand Forks Human Nutrition Research Center</name>
      <address>
        <city>Grand Forks</city>
        <state>North Dakota</state>
        <zip>58201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Body Weight/physiology*</keyword>
  <keyword>Diet*/statistics &amp; numerical data</keyword>
  <keyword>Diet*/trends</keyword>
  <keyword>Exercise/physiology*</keyword>
  <keyword>Female</keyword>
  <keyword>Humans</keyword>
  <keyword>Longitudinal Studies</keyword>
  <keyword>Middle Aged</keyword>
  <keyword>Obesity/epidemiology*</keyword>
  <keyword>Seasons*</keyword>
  <keyword>Time Factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT01674296
org study id: GFHNRC018
nct id: NCT01674296
lead sponsor: 
has dmc: Yes
The purpose of this study is to develop a better understanding of factors affecting
      American's energy balance related behaviors - in this case, food intake and activity. In the
      present study we will describe the relative contributions of individual psychology and
      physiology (including metabolism, mood, and sleep habits) and external (season, stressors)
      contributions to changes in adiposity over a year in free-living individuals.

      This study will illuminate season's role in changes in energy balance related behaviors and
      body weight and composition. Ultimately, this information will be used to identify factors
      affecting food consumption and individual activity during seasonal periods to help to segment
      interventions for obesity prevention in mid-life women.
This is a longitudinal, observational study of mid-life women spanning one year.There will be
      frequent monitoring of food consumption, individual activity and individual- level factors
      thought to influence food consumption and activity such as dietary restraint, subjective
      stress, sleep quality and duration, and physiological stress as measured by allostatic load.

      Specific aims:

        1. To identify seasonal changes in %BF of mid-life women.

           Participant's percentage of body fat will fluctuate, and will be highest at the end of
           the winter season and lowest at the end of the summer season.

        2. To describe predictors of seasonal changes in %BF.

      There will be no intervention other than frequent monitoring of food consumption, individual
      activity and individual- level factors thought to influence food consumption and activity
      such as dietary restraint, subjective stress, sleep quality and duration, and physiological
      stress as measured by allostatic load. The volunteers will be asked to complete a 7-day
      activity and energy expenditure monitoring period (along with body composition assessment,
      questionnaires regarding individual factors thought to affect food consumption and activity,
      blood draw and urine collection to measure allostatic load) in each of the four seasons over
      a 12-month period; between monitoring periods they will come to the GFHNRC for measurement of
      weight, skin carotenoids for assessment of fruit and vegetable intake, and to provide a
      morning urine sample monthly (8 times), and receive emails reminding them to log on to a
      secure server and complete a 24-hr recall 3 times a month (36 times during the year).

      The ASA-24 will be administered to assess nutritional intake; Actigraph GT3X+, Actitrainer,
      and QStarz GPS logger will be used to assess physical activity. Physiological stress will be
      assessed using the allostatic load index.
observational model: Cohort
time perspective: Prospective
measure: Change in body fat
time frame: Season 1, season 2, season 3, season 4
description: Body fat location and amount will be assess by dual-energy X-ray absorptiometry
arm group label: Group 1 (2012-2013)
description: Monitoring of Dietary Intake, Physical Activity and Stress
arm group label: Group 2 (2013-2014)
description: Monitoring of Dietary Intake, Physical Activity and Stress
Serum, Plasma, Buffy Coat, Urine, Saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James Roemmich, PhD
role: Principal Investigator
affiliation: USDA-ARS-GFHNRC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: No