<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/NCT03840733</url>
  </required_header>
  <id_info>
    <org_study_id>18-1319</org_study_id>
    <secondary_id>K01HL145023</secondary_id>
    <nct_id>NCT03840733</nct_id>
  </id_info>
  <brief_title>Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes</brief_title>
  <official_title>Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
      This study is designed as an observational trial. The objective of this study is to follow-up&#xD;
      with participants 3 years after completion of an 18-month comprehensive behavioral weight&#xD;
      loss intervention. Outcomes of interest include change in body weight, body composition,&#xD;
      physical activity, energy intake, and sleep. In addition, investigators will explore the&#xD;
      associations between current physical activity, sleep, and energy intake patterns and body&#xD;
      weight regulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 170 participants were initially enrolled in the comprehensive behavioral weight&#xD;
      loss intervention.In this study, investigators will conduct a follow-up visit 3 years after&#xD;
      the completion of the intervention. Only participants who completed the behavioral weight&#xD;
      loss intervention will be enrolled in this study. Participants will undergo testing of body&#xD;
      weight, body composition, physical activity patterns, energy intake patterns, sleep patterns,&#xD;
      resting metabolic rate, and total daily energy expenditure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Weight Change</measure>
    <time_frame>Baseline to 54 months</time_frame>
    <description>Change in body weight (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight Maintenance</measure>
    <time_frame>18 months to 54 months</time_frame>
    <description>Change in body weight (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat Mass Change</measure>
    <time_frame>Baseline to 54 months</time_frame>
    <description>Change in Fat Mass (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat Free Mass Change</measure>
    <time_frame>Baseline to 54 months</time_frame>
    <description>Change in Fat Free Mass (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat Mass Maintenance</measure>
    <time_frame>18 months to 54 months</time_frame>
    <description>Change in Fat Mass (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat Free Mass Maintenance</measure>
    <time_frame>18 months to 54 months</time_frame>
    <description>Change in Fat Free Mass (kg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity Patterns</measure>
    <time_frame>0, 6, 12, 18, 24, 54 month</time_frame>
    <description>Physical activity patterns as measured by SenseWear armband (min/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Patterns</measure>
    <time_frame>54 month</time_frame>
    <description>Physical activity patterns as measured by ActivPAL, Actigraph (min/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep</measure>
    <time_frame>0, 6, 12, 18, 24, 54 month</time_frame>
    <description>Sleep patterns as measured by SenseWear armband (h/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Patterns</measure>
    <time_frame>54 month</time_frame>
    <description>Sleep patterns as measured by Actiwatch-2, ActivPAL, Actigraph (h/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Energy Intake</measure>
    <time_frame>0, 6, 12, 18, 54 month</time_frame>
    <description>Energy Intake patterns as measured by 3 day food record (kcal/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy Intake Patterns</measure>
    <time_frame>54 month</time_frame>
    <description>Energy Intake patterns as measured by 24 hour food recall and meallogger smartphone application (kcal/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting Metabolic Rate</measure>
    <time_frame>54 month</time_frame>
    <description>Resting metabolic rate as measured using indirect calorimetry (kcal/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Daily Energy Expenditure</measure>
    <time_frame>54 month</time_frame>
    <description>Total Daily Energy Expenditure as measured by doubly labeled water (kcal/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Energy Expenditure</measure>
    <time_frame>54 month</time_frame>
    <description>Physical Activity Energy Expenditure as measured by doubly labeled water (kcal/day)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Change, Body</condition>
  <arm_group>
    <arm_group_label>Participants from NCT01985568 or NCT03411356</arm_group_label>
    <description>All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568 or NCT03411356).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants previously enrolled in an 18-month behavioral weight loss intervention at the&#xD;
        University of Colorado Anschutz Medical Campus. (NCT01985568)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous enrollment in standard behavioral weight loss intervention (NCT01985568 or&#xD;
             NCT03411356)&#xD;
&#xD;
          -  Age 20-60 (This age range has been selected based upon the participants enrolled in&#xD;
             the Parent Trial)&#xD;
&#xD;
          -  Capable and willing to give informed consent&#xD;
&#xD;
          -  Possess a smartphone to install and utilize the meal timing application&#xD;
&#xD;
          -  Capable and willing to wear the Actigraph, ActivPAL and Actiwatch-2 for 24 hours/day&#xD;
             for 28 consecutive days&#xD;
&#xD;
          -  Willing to complete the Total Daily Energy Expenditure (TDEE) assessment which&#xD;
             includes multiple urine collections and drinking stable water isotopes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being considered unsafe to participate as determined by the study physician (Dr.&#xD;
             Catennaci)&#xD;
&#xD;
          -  New diagnosis of a medical condition (not observed in the Parent Trial) which may&#xD;
             affect weight or energy metabolism (e.g. depression, CVD, diabetes, uncontrolled&#xD;
             hypertension, untreated thyroid, renal, hepatic diseases)&#xD;
&#xD;
          -  Women who became pregnant after completing the Parent Trial&#xD;
&#xD;
          -  Current use or use within the last 6 months of prescription or over-the-counter&#xD;
             medications known to affect appetite, weight, and sleep&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seth A Creasy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>sleep</keyword>
  <keyword>eating patterns</keyword>
  <keyword>energy expenditure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</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>


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/NCT03840733
org study id: 18-1319
secondary id: K01HL145023
nct id: NCT03840733
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed as an observational trial. The objective of this study is to follow-up
      with participants 3 years after completion of an 18-month comprehensive behavioral weight
      loss intervention. Outcomes of interest include change in body weight, body composition,
      physical activity, energy intake, and sleep. In addition, investigators will explore the
      associations between current physical activity, sleep, and energy intake patterns and body
      weight regulation.
A total of 170 participants were initially enrolled in the comprehensive behavioral weight
      loss intervention.In this study, investigators will conduct a follow-up visit 3 years after
      the completion of the intervention. Only participants who completed the behavioral weight
      loss intervention will be enrolled in this study. Participants will undergo testing of body
      weight, body composition, physical activity patterns, energy intake patterns, sleep patterns,
      resting metabolic rate, and total daily energy expenditure.
observational model: Cohort
time perspective: Prospective
measure: Weight Change
time frame: Baseline to 54 months
description: Change in body weight (kg)
measure: Weight Maintenance
time frame: 18 months to 54 months
description: Change in body weight (kg)
measure: Fat Mass Change
time frame: Baseline to 54 months
description: Change in Fat Mass (kg)
measure: Fat Free Mass Change
time frame: Baseline to 54 months
description: Change in Fat Free Mass (kg)
measure: Fat Mass Maintenance
time frame: 18 months to 54 months
description: Change in Fat Mass (kg)
measure: Fat Free Mass Maintenance
time frame: 18 months to 54 months
description: Change in Fat Free Mass (kg)
measure: Change in Physical Activity Patterns
time frame: 0, 6, 12, 18, 24, 54 month
description: Physical activity patterns as measured by SenseWear armband (min/day)
measure: Physical Activity Patterns
time frame: 54 month
description: Physical activity patterns as measured by ActivPAL, Actigraph (min/day)
measure: Change in Sleep
time frame: 0, 6, 12, 18, 24, 54 month
description: Sleep patterns as measured by SenseWear armband (h/day)
measure: Sleep Patterns
time frame: 54 month
description: Sleep patterns as measured by Actiwatch-2, ActivPAL, Actigraph (h/day)
measure: Change in Energy Intake
time frame: 0, 6, 12, 18, 54 month
description: Energy Intake patterns as measured by 3 day food record (kcal/day
measure: Energy Intake Patterns
time frame: 54 month
description: Energy Intake patterns as measured by 24 hour food recall and meallogger smartphone application (kcal/day)
measure: Resting Metabolic Rate
time frame: 54 month
description: Resting metabolic rate as measured using indirect calorimetry (kcal/day)
measure: Total Daily Energy Expenditure
time frame: 54 month
description: Total Daily Energy Expenditure as measured by doubly labeled water (kcal/day)
measure: Physical Activity Energy Expenditure
time frame: 54 month
description: Physical Activity Energy Expenditure as measured by doubly labeled water (kcal/day)
arm group label: Participants from NCT01985568 or NCT03411356
description: All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568 or NCT03411356).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Seth A Creasy, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Body Weight
mesh term: Weight Loss
mesh term: Body Weight Changes
sharing ipd: No