<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/NCT01674751</url>
  </required_header>
  <id_info>
    <org_study_id>HN 4262</org_study_id>
    <nct_id>NCT01674751</nct_id>
  </id_info>
  <brief_title>What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work</brief_title>
  <official_title>What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein Healthcare Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aramark Healthcare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Albert Einstein Healthcare Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will test the feasibility and potential effectiveness of a novel approach to&#xD;
      improve food choices by employees about what to eat for lunch. The intervention involves the&#xD;
      testing of an on-line pre-ordering food program with nutritional information linked to a&#xD;
      hospital cafeteria. In this study, the investigators use positive reinforcement of feedback&#xD;
      and price discounts during the intervention phase, and then withdraw those components in&#xD;
      order to assess the potential for changes to be retained after the study is over.&#xD;
&#xD;
      The study draws on principles from the field of behavioral economics and behavioral change.&#xD;
      The investigators test the effectiveness of the intervention with 30 employees (study&#xD;
      participants) who are overweight or obese. Based on a recent screening of over 5600 Einstein&#xD;
      employees, 66% of those screened were identified as either overweight or obese. There are 3&#xD;
      phases to the trial: baseline (P1), 4 week intervention, (P2) and tapering (intervention&#xD;
      without reinforcement) (P3). Participants are randomized to one of two groups (intervention&#xD;
      and wait-listed controls).&#xD;
&#xD;
      Our primary hypotheses are that:&#xD;
&#xD;
        1. Participants will purchase lunches with fewer calories during the intervention compared&#xD;
           to baseline.&#xD;
&#xD;
        2. Participants will purchases lunches with fewer calories in the tapering phase compared&#xD;
           to baseline.&#xD;
&#xD;
      Secondary hypotheses include that, compared with baseline, participants will order lunches&#xD;
      with less fat. Changes in participant weight based on self selected goals, and in a measure&#xD;
      of mindful eating will also be investigated. The investigators expect that participant&#xD;
      adherence will be associated with improved outcomes compared to those who are less adherent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total number of calories</measure>
    <time_frame>Participants are followed for a minimum of 12 weeks and the total calories from their lunchtime meals are recorded daily.</time_frame>
    <description>The average number of calories (Kcal) purchased for lunch.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of calories from fat</measure>
    <time_frame>Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.</time_frame>
    <description>The average number of calories from fat (g) purchased for lunch.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant adherence</measure>
    <time_frame>Participants are followed for a minimum of 12 weeks</time_frame>
    <description>Participant adherence is measured by the participants' self-report of engagement in the intervention activities, objective measure of using the pre-ordering system to place lunch purchases, objective measure of the purchase of lunch in the study cafeteria, completion of study materials, and participant report of barriers to engagement in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant body weight (kg)</measure>
    <time_frame>Recorded at the time of recruitment into the study and again following the 8 week intervention</time_frame>
    <description>The average percent change in body weight from baseline to end of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c (HbA1c)</measure>
    <time_frame>Measured at the time of recruitment into the study and again following the 8 week intervention</time_frame>
    <description>The average change in participant Hemoglobin A1c (HbA1c, mmol/mol) will be reported in order to assess change in average plasma glucose concentrations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol subfractions</measure>
    <time_frame>Measured at the time of recruitment into the study and again following the 8 week intervention</time_frame>
    <description>The average change in participant cholesterol subfractions (g/mL) will be reported in order to evaluate change in risk of coronary heart disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure (mmHg)</measure>
    <time_frame>Measured at the time of recruitment into the study and again following the 8 week intervention</time_frame>
    <description>The average change in blood pleasure (mmHg) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful eating score on 28-item self-report measure</measure>
    <time_frame>Recorded at the time of recruitment into the study and again following the 8 week intervention</time_frame>
    <description>The average change in mindfulness when eating will be reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Dietary Habits</condition>
  <arm_group>
    <arm_group_label>Immediate intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-listed control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-ordering program</intervention_name>
    <description>During the 4 week intervention phase, participants use the pre-ordering program, receive a novel, &quot;smart receipt&quot; upon checkout that will detail the caloric and fat content of what they ordered, and receive price discounts for select low calorie and low fat items. The pre-ordering system is designed to provide the opportunity for the individual to see what is available along with nutritional information and to make a selection ahead of time.</description>
    <arm_group_label>Immediate intervention</arm_group_label>
    <arm_group_label>Wait-listed control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Interested in improving their food choices as it relates to healthier eating and&#xD;
             weight loss&#xD;
&#xD;
          -  Adult employee at large, urban hospital in Philadelphia at which study is being&#xD;
             conducted&#xD;
&#xD;
          -  Eats at least 4 lunch meals a week at study cafeteria&#xD;
&#xD;
          -  BMI greater than or equal to 25.0 (based on standard classification).&#xD;
&#xD;
          -  Willingness to allow researchers to collect data about their lunch purchases&#xD;
&#xD;
          -  Willingness to &quot;swipe&quot; their employee card for lunch purchases during the study&#xD;
&#xD;
          -  Access to a computer at work&#xD;
&#xD;
          -  Capable of providing informed consent&#xD;
&#xD;
          -  Has a way of being contacted by telephone, email, fax, or receiving a text message&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planning to terminate hospital employment within the next 4 months&#xD;
&#xD;
          -  Individuals unable to consent&#xD;
&#xD;
          -  Individuals who are not yet adults&#xD;
&#xD;
          -  Employees who are pregnant&#xD;
&#xD;
          -  Employees with hypertension, dyslipidemia or coronary artery disease whose medical&#xD;
             therapy has changed in the past 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Etienne J Phipps, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein Healthcare Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Albert Einstein Healthcare Network</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>February 21, 2014</last_update_submitted>
  <last_update_submitted_qc>February 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein Healthcare Network</investigator_affiliation>
    <investigator_full_name>Etienne Phipps</investigator_full_name>
    <investigator_title>Director Einstein Urban Health</investigator_title>
  </responsible_party>
  <keyword>pre-ordering</keyword>
  <keyword>healthy eating</keyword>
  <keyword>mindfulness</keyword>
  <keyword>incentives</keyword>
  <keyword>employees</keyword>
  <!-- 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/NCT01674751
org study id: HN 4262
nct id: NCT01674751
lead sponsor: 
collaborator: 
has dmc: No
This pilot study will test the feasibility and potential effectiveness of a novel approach to
      improve food choices by employees about what to eat for lunch. The intervention involves the
      testing of an on-line pre-ordering food program with nutritional information linked to a
      hospital cafeteria. In this study, the investigators use positive reinforcement of feedback
      and price discounts during the intervention phase, and then withdraw those components in
      order to assess the potential for changes to be retained after the study is over.

      The study draws on principles from the field of behavioral economics and behavioral change.
      The investigators test the effectiveness of the intervention with 30 employees (study
      participants) who are overweight or obese. Based on a recent screening of over 5600 Einstein
      employees, 66% of those screened were identified as either overweight or obese. There are 3
      phases to the trial: baseline (P1), 4 week intervention, (P2) and tapering (intervention
      without reinforcement) (P3). Participants are randomized to one of two groups (intervention
      and wait-listed controls).

      Our primary hypotheses are that:

        1. Participants will purchase lunches with fewer calories during the intervention compared
           to baseline.

        2. Participants will purchases lunches with fewer calories in the tapering phase compared
           to baseline.

      Secondary hypotheses include that, compared with baseline, participants will order lunches
      with less fat. Changes in participant weight based on self selected goals, and in a measure
      of mindful eating will also be investigated. The investigators expect that participant
      adherence will be associated with improved outcomes compared to those who are less adherent.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Total number of calories
time frame: Participants are followed for a minimum of 12 weeks and the total calories from their lunchtime meals are recorded daily.
description: The average number of calories (Kcal) purchased for lunch.
measure: Total number of calories from fat
time frame: Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.
description: The average number of calories from fat (g) purchased for lunch.
measure: Participant adherence
time frame: Participants are followed for a minimum of 12 weeks
description: Participant adherence is measured by the participants' self-report of engagement in the intervention activities, objective measure of using the pre-ordering system to place lunch purchases, objective measure of the purchase of lunch in the study cafeteria, completion of study materials, and participant report of barriers to engagement in the study.
measure: Participant body weight (kg)
time frame: Recorded at the time of recruitment into the study and again following the 8 week intervention
description: The average percent change in body weight from baseline to end of the intervention.
measure: Hemoglobin A1c (HbA1c)
time frame: Measured at the time of recruitment into the study and again following the 8 week intervention
description: The average change in participant Hemoglobin A1c (HbA1c, mmol/mol) will be reported in order to assess change in average plasma glucose concentrations.
measure: Cholesterol subfractions
time frame: Measured at the time of recruitment into the study and again following the 8 week intervention
description: The average change in participant cholesterol subfractions (g/mL) will be reported in order to evaluate change in risk of coronary heart disease.
measure: Blood pressure (mmHg)
time frame: Measured at the time of recruitment into the study and again following the 8 week intervention
description: The average change in blood pleasure (mmHg) will be reported.
measure: Mindful eating score on 28-item self-report measure
time frame: Recorded at the time of recruitment into the study and again following the 8 week intervention
description: The average change in mindfulness when eating will be reported.
arm group label: Immediate intervention
arm group type: Experimental
description: Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.
arm group label: Wait-listed control
arm group type: Other
description: Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.
intervention type: Other
intervention name: Pre-ordering program
description: During the 4 week intervention phase, participants use the pre-ordering program, receive a novel, "smart receipt" upon checkout that will detail the caloric and fat content of what they ordered, and receive price discounts for select low calorie and low fat items. The pre-ordering system is designed to provide the opportunity for the individual to see what is available along with nutritional information and to make a selection ahead of time.
arm group label: Immediate intervention
arm group label: Wait-listed control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Etienne J Phipps, PhD
role: Principal Investigator
affiliation: Albert Einstein Healthcare Network
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein Healthcare Network
investigator full name: Etienne Phipps
investigator title: Director Einstein Urban Health