<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/NCT01678885</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 27007</org_study_id>
    <nct_id>NCT01678885</nct_id>
  </id_info>
  <brief_title>Assessment of Energy Balance</brief_title>
  <acronym>EnergyBalanc</acronym>
  <official_title>Assessment of Energy Balance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to test different methods of measuring energy balance,&#xD;
      including food intake and energy expenditure. Another primary purpose of this study is to see&#xD;
      if energy expenditure predicts weight and change after a weight loss diet. A secondary aim&#xD;
      will be to test the reliability and validity of the Actical accelerometer, SenseWear&#xD;
      Armbands, and the Intelligent Device for Energy Expenditure and Activity (IDEAA) monitors at&#xD;
      measuring activity energy expenditure (AEE) and total daily energy expenditure (TEE) against&#xD;
      the gold standard, doubly-labeled water (DLW). Similarly, we will test whether the estimated&#xD;
      energy expenditure or posture allocation from the 3 devices is associated with weight change&#xD;
      during and following a low calorie diet (LCD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will take place over a period of one year. Participants will spend 3 weeks&#xD;
      completing Phase I, and eight weeks completing Phase II (the weight loss phase of the study).&#xD;
      Then, participants will return to the center at months 6 and 12 for a follow-up visit. During&#xD;
      these visits, body weight, blood pressure, and pulse will be recorded, and questionnaires&#xD;
      about eating attitudes and habits will be collected and assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2007</start_date>
  <completion_date type="Actual">December 2009</completion_date>
  <primary_completion_date type="Actual">December 2009</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY</measure>
    <time_frame>~6 days</time_frame>
    <description>A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions for 1 week. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight Change</measure>
    <time_frame>1 year</time_frame>
    <description>The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)</measure>
    <time_frame>1 week</time_frame>
    <description>Bland-Altman analyses compared the TDEE and AEE from the Sensewear® and IDEEA and Actical monitors to the DLW data from the week participants wore the monitors. Only the week of DLW data that corresponded with the wearing of the monitors was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Predictions of % Weight Change During and After an 8-week LCD</measure>
    <time_frame>8 weeks</time_frame>
    <description>This secondary aim of the study was evaluated with linear regression analysis to determine if TEE, AEE, or measures of posture allocation predicted weight loss during the 8-week LCD. Percent weight change from diet initiation to termination was the dependent variable for the weight loss regressions. Of the 87 participants considered for these secondary analyses, five were excluded because they did not finish baseline accelerometry assessment, and an additional five were excluded because they did not enter the LCD phase due to BMI's &lt; 25. Finally, seven more participants from this original sample were excluded because they did not successfully complete all aspects of the DLW dosing period. Finally, an additional 4 subjects were lost to follow up during the 8-week LCD period. Thus, 66 participants were included in the analysis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Caloric Intake and Energy Metabolism</condition>
  <arm_group>
    <arm_group_label>Sub-study 1, Dig Photo, Actical &amp; IDEEA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During one week of the doubly labeled water (DLW), participants will use digital photography of foods. During the other week of the DLW phase, participants will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and Actical monitor. Whether the participants wear the monitors first or complete digital photography first will be randomozed. Participants who complete the first two weeks and have a BMI over 25kg/m2 will receive a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan is a 1000-1150 kcal/day diet that participants will complete in a free-living environment. All participants will return to follow-up at six and twelve months after they completed the LCD. Anthropometric and questionnaire data will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-study 2 - Dig Photo &amp; Sensewear</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During one week of the doubly labeled water (DLW) period, participants will use digital photography of foods. During the other week of the DLW phase, participants will wear the Sensewear armband. Whether the participants wear the monitor first or complete digital photography first will be randomozed. Participants who complete the first two weeks and have a BMI over 25kg/m2 will receive a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan is a 1000-1150 kcal/day diet that participants will complete in a free-living environment. All participants will return to follow-up at six and twelve months after they completed the LCD. Anthropometric and questionnaire data will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Digital Photography of Foods</intervention_name>
    <description>The digital photography of foods method was developed to unobtrusively measure energy intake in naturalistic settings (e.g., cafeterias). Participants will be provided with cell-phones with digital cameras and cellular network capability. Participants were trained to take pictures of their food selection and plate waste and to send these pictures to the researchers over the cellular network. The participant will collect data in free-living conditions and these data will be collected in near real time.</description>
    <arm_group_label>Sub-study 1, Dig Photo, Actical &amp; IDEEA</arm_group_label>
    <arm_group_label>Sub-study 2 - Dig Photo &amp; Sensewear</arm_group_label>
    <other_name>digital photography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>doubly labeled water</intervention_name>
    <description>Doubly labeled water, considered the gold standard for measuring energy intake in humans, was used to measure total daily energy expenditure during free-living conditions. DLW is used to obtain an accurate measure of total daily energy expenditure, which is equal to energy intake during energy balance.</description>
    <arm_group_label>Sub-study 1, Dig Photo, Actical &amp; IDEEA</arm_group_label>
    <arm_group_label>Sub-study 2 - Dig Photo &amp; Sensewear</arm_group_label>
    <other_name>Doubly labeled water (DLW)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IDEEA</intervention_name>
    <description>The Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.</description>
    <arm_group_label>Sub-study 1, Dig Photo, Actical &amp; IDEEA</arm_group_label>
    <other_name>Intelligent Device for Energy Expenditure and Activity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>low-calorie diet</intervention_name>
    <description>Participants will be instructed to consume five packets of Health One per day, which provides 800 kcal and 125% of Recommended Daily Intake of vitamins and minerals. Additionally participants will be instructed to consume a meal consisting of 200 kcal to 350 kcal daily, which could consist of a portion-controlled meal replacement or a home-cooked meal. Participants will meet with a Registered Dietitian at weeks 0, 2, 4, and 6 and receive instructions on adhering to the meal plan.</description>
    <arm_group_label>Sub-study 1, Dig Photo, Actical &amp; IDEEA</arm_group_label>
    <arm_group_label>Sub-study 2 - Dig Photo &amp; Sensewear</arm_group_label>
    <other_name>LCD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Actical</intervention_name>
    <description>The Actical will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.</description>
    <arm_group_label>Sub-study 1, Dig Photo, Actical &amp; IDEEA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sensewear Armband</intervention_name>
    <description>The Sensewear armband will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.</description>
    <arm_group_label>Sub-study 2 - Dig Photo &amp; Sensewear</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years&#xD;
&#xD;
          -  Body Mass Index 25-40&#xD;
&#xD;
          -  Willing to eat foods provided for two days.&#xD;
&#xD;
          -  Willing to wear the IDEEA( Intelligent Device for Energy Expenditure and Activity),&#xD;
             which is a device that attaches to the body and records movement and activity.&#xD;
&#xD;
          -  Willing to wear an accelerometer, which is similar to a pager that attaches to belt or&#xD;
             clothing and measures activity.&#xD;
&#xD;
          -  Willing to use a cell phone equipped with a digital camera to take pictures of foods&#xD;
             for one week.&#xD;
&#xD;
          -  Willing to undergo an 8 week weight loss diet, consisting of supplement or powdered&#xD;
             shakes, portion-controlled entrees, or home-cooked meals.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of diabetes, cardiovascular disease, or cancer.&#xD;
&#xD;
          -  Females who are pregnant or planning to become pregnant during the trail.&#xD;
&#xD;
          -  Medications that influence appetite or body weight (weight loss medications such as&#xD;
             sibutramine, antipsychotic medications such as olanzapine, or herbal weight loss&#xD;
             products) taken during the previous three months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corby K Martin, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>December 20, 2012</results_first_submitted>
  <results_first_submitted_qc>September 19, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 22, 2014</results_first_posted>
  <last_update_submitted>May 28, 2017</last_update_submitted>
  <last_update_submitted_qc>May 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Corby K. Martin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Phase I Sub-study 1 - Dig Photo First, Then IDEEA &amp; Actical</title>
          <description>Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.</description>
        </group>
        <group group_id="P2">
          <title>Phase 1 Sub-study 1 - IDEEA &amp; Actical First, Then Dig Photo</title>
          <description>Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.</description>
        </group>
        <group group_id="P3">
          <title>Phase 1 Sub Study 2 - Dig Photo First, Then Sensewear</title>
          <description>Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.</description>
        </group>
        <group group_id="P4">
          <title>Phase I Sub Study 2 - Sensewear First, Then Digital Photo</title>
          <description>Phase 1- sensewear First, Then Digital Photography</description>
        </group>
        <group group_id="P5">
          <title>Phase 2- Low-Calorie Diet</title>
          <description>Participants from sub-study 1 and 2 had the chance to receive the low-calorie diet based on their eligibility; i.e., BMI level.&#xD;
Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Phase I; 2 Wks Duration, Both Sub-study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="24"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="21"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Phase II; 8 Week Low Calorie Diet</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sub-study 1</title>
          <description>During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.</description>
        </group>
        <group group_id="B2">
          <title>Sub-study 2</title>
          <description>During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="87"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY</title>
        <description>A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions for 1 week. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.</description>
        <time_frame>~6 days</time_frame>
        <population>Free-living energy intake data were analyzed from the 40 participants who completed the protocol and provided urine samples for doubly labeled water analysis. This primary outcome measure was limited to one sub-study.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1</title>
            <description>During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.</description>
          </group>
        </group_list>
        <measure>
          <title>ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY</title>
          <description>A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions for 1 week. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.</description>
          <population>Free-living energy intake data were analyzed from the 40 participants who completed the protocol and provided urine samples for doubly labeled water analysis. This primary outcome measure was limited to one sub-study.</population>
          <units>kCal</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EI (kcal) Measured with DLW</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2360" spread="626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EI (kcal) Measured with RFPM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2208" spread="665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference of EI (kcal) measured with DLW and RFPM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-152" spread="694"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight Change</title>
        <description>The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss.</description>
        <time_frame>1 year</time_frame>
        <population>Weight change was evaluated from all participants who received the low calorie diet in sub-studies 1 and 2 combined.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase II</title>
            <description>Participants who complete Phase I of the study received a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan was a 1000-1150 kcal/day diet composed of Health One shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data was collected.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Change</title>
          <description>The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss.</description>
          <population>Weight change was evaluated from all participants who received the low calorie diet in sub-studies 1 and 2 combined.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)</title>
        <description>Bland-Altman analyses compared the TDEE and AEE from the Sensewear® and IDEEA and Actical monitors to the DLW data from the week participants wore the monitors. Only the week of DLW data that corresponded with the wearing of the monitors was used for this analysis.</description>
        <time_frame>1 week</time_frame>
        <population>Of the 87 participants considered from phase 1 of sub-studies 1 and 2, five were excluded because they did not finish baseline accelerometry assessment, five were excluded because they did not enter the LCD due to BMI's &lt; 25. Seven were excluded because they did not successfully complete all aspects of the DLW dosing period.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)</title>
          <description>Bland-Altman analyses compared the TDEE and AEE from the Sensewear® and IDEEA and Actical monitors to the DLW data from the week participants wore the monitors. Only the week of DLW data that corresponded with the wearing of the monitors was used for this analysis.</description>
          <population>Of the 87 participants considered from phase 1 of sub-studies 1 and 2, five were excluded because they did not finish baseline accelerometry assessment, five were excluded because they did not enter the LCD due to BMI's &lt; 25. Seven were excluded because they did not successfully complete all aspects of the DLW dosing period.</population>
          <units>kcal/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>kcal/day; Sensewear TEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-59.98" spread="411.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>kcal/day, IDEEA TEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.72" spread="467.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>kcal/day, Actical Waist AEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-111.38" spread="354.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>kcal/day, Actical Wrist AEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="194.52" spread="454.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>kcal/day, Sensewear AEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-416.95" spread="370.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>kcal/day, IDEEA AEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.77" spread="436.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Device Predictions of % Weight Change During and After an 8-week LCD</title>
        <description>This secondary aim of the study was evaluated with linear regression analysis to determine if TEE, AEE, or measures of posture allocation predicted weight loss during the 8-week LCD. Percent weight change from diet initiation to termination was the dependent variable for the weight loss regressions. Of the 87 participants considered for these secondary analyses, five were excluded because they did not finish baseline accelerometry assessment, and an additional five were excluded because they did not enter the LCD phase due to BMI's &lt; 25. Finally, seven more participants from this original sample were excluded because they did not successfully complete all aspects of the DLW dosing period. Finally, an additional 4 subjects were lost to follow up during the 8-week LCD period. Thus, 66 participants were included in the analysis</description>
        <time_frame>8 weeks</time_frame>
        <population>Participants from sub-study 1 and 2 combined were used in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All study participants were included in these analyses</description>
          </group>
        </group_list>
        <measure>
          <title>Device Predictions of % Weight Change During and After an 8-week LCD</title>
          <description>This secondary aim of the study was evaluated with linear regression analysis to determine if TEE, AEE, or measures of posture allocation predicted weight loss during the 8-week LCD. Percent weight change from diet initiation to termination was the dependent variable for the weight loss regressions. Of the 87 participants considered for these secondary analyses, five were excluded because they did not finish baseline accelerometry assessment, and an additional five were excluded because they did not enter the LCD phase due to BMI's &lt; 25. Finally, seven more participants from this original sample were excluded because they did not successfully complete all aspects of the DLW dosing period. Finally, an additional 4 subjects were lost to follow up during the 8-week LCD period. Thus, 66 participants were included in the analysis</description>
          <population>Participants from sub-study 1 and 2 combined were used in this analysis.</population>
          <units>R squared</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Actical (waist) AEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Actical (wrist) AEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensewear TEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensewear AEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IDEEA TEE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse events reported for Phase 1 and 2. Participants are stratified by the sub-studies.</desc>
      <group_list>
        <group group_id="E1">
          <title>Sub-study 1</title>
          <description>Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.</description>
        </group>
        <group group_id="E2">
          <title>Sub-study 2</title>
          <description>Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study included a 2-week doubly labeled water phase; hence, the activity and energy intake assessments were limited this period.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Corby Martin, Ph.D.</name_or_title>
      <organization>Pennington Biomedical Research Center</organization>
      <phone>225-763-2585</phone>
      <email>corby.martin@pbrc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01678885
org study id: PBRC 27007
nct id: NCT01678885
lead sponsor: 
has dmc: No
The primary purpose of this study is to test different methods of measuring energy balance,
      including food intake and energy expenditure. Another primary purpose of this study is to see
      if energy expenditure predicts weight and change after a weight loss diet. A secondary aim
      will be to test the reliability and validity of the Actical accelerometer, SenseWear
      Armbands, and the Intelligent Device for Energy Expenditure and Activity (IDEAA) monitors at
      measuring activity energy expenditure (AEE) and total daily energy expenditure (TEE) against
      the gold standard, doubly-labeled water (DLW). Similarly, we will test whether the estimated
      energy expenditure or posture allocation from the 3 devices is associated with weight change
      during and following a low calorie diet (LCD).
The study will take place over a period of one year. Participants will spend 3 weeks
      completing Phase I, and eight weeks completing Phase II (the weight loss phase of the study).
      Then, participants will return to the center at months 6 and 12 for a follow-up visit. During
      these visits, body weight, blood pressure, and pulse will be recorded, and questionnaires
      about eating attitudes and habits will be collected and assessed.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY
time frame: ~6 days
description: A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions for 1 week. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.
measure: Weight Change
time frame: 1 year
description: The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss.
measure: Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)
time frame: 1 week
description: Bland-Altman analyses compared the TDEE and AEE from the Sensewear® and IDEEA and Actical monitors to the DLW data from the week participants wore the monitors. Only the week of DLW data that corresponded with the wearing of the monitors was used for this analysis.
measure: Device Predictions of % Weight Change During and After an 8-week LCD
time frame: 8 weeks
description: This secondary aim of the study was evaluated with linear regression analysis to determine if TEE, AEE, or measures of posture allocation predicted weight loss during the 8-week LCD. Percent weight change from diet initiation to termination was the dependent variable for the weight loss regressions. Of the 87 participants considered for these secondary analyses, five were excluded because they did not finish baseline accelerometry assessment, and an additional five were excluded because they did not enter the LCD phase due to BMI's < 25. Finally, seven more participants from this original sample were excluded because they did not successfully complete all aspects of the DLW dosing period. Finally, an additional 4 subjects were lost to follow up during the 8-week LCD period. Thus, 66 participants were included in the analysis
arm group label: Sub-study 1, Dig Photo, Actical & IDEEA
arm group type: Experimental
description: During one week of the doubly labeled water (DLW), participants will use digital photography of foods. During the other week of the DLW phase, participants will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and Actical monitor. Whether the participants wear the monitors first or complete digital photography first will be randomozed. Participants who complete the first two weeks and have a BMI over 25kg/m2 will receive a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan is a 1000-1150 kcal/day diet that participants will complete in a free-living environment. All participants will return to follow-up at six and twelve months after they completed the LCD. Anthropometric and questionnaire data will be collected.
arm group label: Sub-study 2 - Dig Photo & Sensewear
arm group type: Experimental
description: During one week of the doubly labeled water (DLW) period, participants will use digital photography of foods. During the other week of the DLW phase, participants will wear the Sensewear armband. Whether the participants wear the monitor first or complete digital photography first will be randomozed. Participants who complete the first two weeks and have a BMI over 25kg/m2 will receive a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan is a 1000-1150 kcal/day diet that participants will complete in a free-living environment. All participants will return to follow-up at six and twelve months after they completed the LCD. Anthropometric and questionnaire data will be collected.
intervention type: Behavioral
intervention name: Digital Photography of Foods
description: The digital photography of foods method was developed to unobtrusively measure energy intake in naturalistic settings (e.g., cafeterias). Participants will be provided with cell-phones with digital cameras and cellular network capability. Participants were trained to take pictures of their food selection and plate waste and to send these pictures to the researchers over the cellular network. The participant will collect data in free-living conditions and these data will be collected in near real time.
arm group label: Sub-study 1, Dig Photo, Actical & IDEEA
arm group label: Sub-study 2 - Dig Photo & Sensewear
other name: digital photography
intervention type: Other
intervention name: doubly labeled water
description: Doubly labeled water, considered the gold standard for measuring energy intake in humans, was used to measure total daily energy expenditure during free-living conditions. DLW is used to obtain an accurate measure of total daily energy expenditure, which is equal to energy intake during energy balance.
arm group label: Sub-study 1, Dig Photo, Actical & IDEEA
arm group label: Sub-study 2 - Dig Photo & Sensewear
other name: Doubly labeled water (DLW)
intervention type: Device
intervention name: IDEEA
description: The Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
arm group label: Sub-study 1, Dig Photo, Actical & IDEEA
other name: Intelligent Device for Energy Expenditure and Activity
intervention type: Behavioral
intervention name: low-calorie diet
description: Participants will be instructed to consume five packets of Health One per day, which provides 800 kcal and 125% of Recommended Daily Intake of vitamins and minerals. Additionally participants will be instructed to consume a meal consisting of 200 kcal to 350 kcal daily, which could consist of a portion-controlled meal replacement or a home-cooked meal. Participants will meet with a Registered Dietitian at weeks 0, 2, 4, and 6 and receive instructions on adhering to the meal plan.
arm group label: Sub-study 1, Dig Photo, Actical & IDEEA
arm group label: Sub-study 2 - Dig Photo & Sensewear
other name: LCD
intervention type: Device
intervention name: Actical
description: The Actical will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
arm group label: Sub-study 1, Dig Photo, Actical & IDEEA
intervention type: Device
intervention name: Sensewear Armband
description: The Sensewear armband will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
arm group label: Sub-study 2 - Dig Photo & Sensewear
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Corby K Martin, Ph.D.
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Corby K. Martin
investigator title: Principal Investigator
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study included a 2-week doubly labeled water phase; hence, the activity and energy intake assessments were limited this period.
point of contact: 