<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/NCT03252158</url>
  </required_header>
  <id_info>
    <org_study_id>PRE.2017.029</org_study_id>
    <nct_id>NCT03252158</nct_id>
  </id_info>
  <brief_title>Altering the Availability of Healthier vs. Less Healthy Items in Vending Machines</brief_title>
  <official_title>Impact of the Availability of Healthier vs. Less Healthy Foods and Beverages on Purchasing From Hospital Vending Machines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cambridge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oxford University Hospitals NHS Foundations Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cambridge</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>
      Background: While there is some evidence that increasing the range of healthier foods and&#xD;
      drinks and/or decreasing the range of less healthy options may increase healthier choices,&#xD;
      more work is needed to establish the reproducibility of any effect. The current study aims to&#xD;
      investigate the impact of altering the availability of healthier and less healthy foods and&#xD;
      cold beverages in hospital vending machines.&#xD;
&#xD;
      Methods: An adapted multiple treatment reversal design will be used, in which all standard&#xD;
      vending machines serving snack foods and/or cold beverages in one hospital in England change&#xD;
      the number of slots containing (i) less healthy items and (ii) healthier items over eight&#xD;
      4-week periods. Changes will take place in a two-step process whereby decreases are&#xD;
      implemented in a separate study period prior to increases in the contrasting food group.&#xD;
      Following a 4-week baseline period, all vending machines will be standardised to have 75%&#xD;
      healthier drinks and/or 25% healthier snacks (study period 1). Vending machines (n=9) will be&#xD;
      randomly allocated to the order in which they: (1) decrease less healthy foods and increase&#xD;
      healthier foods or (2) decrease healthier foods and increase less healthy foods (study&#xD;
      periods 2&amp;3 and 5&amp;6). After each decrease-increase pair, machines will return to the&#xD;
      standardised 75% healthier drinks and 25% healthier snacks (study periods 4 and 7). Sales&#xD;
      data will be obtained via records of machine restocking.&#xD;
&#xD;
      Planned Analysis: The impact of the availability intervention will be assessed in separate&#xD;
      linear mixed models for cold drinks and snacks, examining the impact on total energy (kcal)&#xD;
      purchased, per restocking interval, with random effects for vending machine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2017</start_date>
  <completion_date type="Actual">March 28, 2018</completion_date>
  <primary_completion_date type="Actual">March 28, 2018</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>
    <intervention_model_description>An adapted multiple treatment reversal design will be used, in which the number of slots containing (i) less healthy items and (ii) healthier items are altered over eight 4-week periods.&#xD;
Vending machines will be randomly allocated to one of two groups: (1) decreasing less healthy foods first or (2) decreasing healthier foods first.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy purchased</measure>
    <time_frame>Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)</time_frame>
    <description>Energy purchased (kcal) per restocking interval from intervention (standard-fare) vending machines</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of items sold</measure>
    <time_frame>Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)</time_frame>
    <description>Number of items sold per restocking interval from intervention (standard-fare) vending machines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy purchased (healthier alternative machines)</measure>
    <time_frame>Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)</time_frame>
    <description>Energy purchased (kcal) per restocking interval from non-intervention (healthier-fare) vending machines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of items sold (healthier alternative machines)</measure>
    <time_frame>Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)</time_frame>
    <description>Number of items sold per restocking interval from non-intervention (healthier-fare) vending machines</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy Diet</condition>
  <arm_group>
    <arm_group_label>Decrease less healthy item availability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Availability of healthier vs. less healthy foods&#xD;
Remove less healthy items in 20% of slots, then fill the empty slots with healthier items.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decrease healthier item availability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Availability of healthier vs. less healthy foods&#xD;
Remove healthier items in 20% of slots, then fill the empty slots with less healthy items.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Availability of healthier vs. less healthy foods</intervention_name>
    <description>Altering the number of slots containing (a) healthier and (b) less healthy foods or beverages in hospital vending machines.&#xD;
Changes follow a 2-step process whereby decreases are implemented in a separate study period prior to increases in the contrasting group. Following a 4-week baseline period, all vending machines will be standardised to have 75% healthier drinks and/or 25% healthier snacks (study period 1). Vending machines will be randomly allocated to the order in which they: (1) decrease less healthy foods and increase healthier foods or (2) decrease healthier foods and increase less healthy foods (study periods 2&amp;3 and 5&amp;6). After each decrease-increase pair, machines will return to the standardised 75% healthier drinks / 25% healthier snacks (study periods 4 and 7).</description>
    <arm_group_label>Decrease healthier item availability</arm_group_label>
    <arm_group_label>Decrease less healthy item availability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All vending machines at one UK hospital selling standard-fare (i.e. not healthier&#xD;
             alternatives) cold beverages and snack foods&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthier alternative vending machines; vending machines selling hot drinks or meals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Pechey, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cambridge</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Cambridge</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0SR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cambridge</investigator_affiliation>
    <investigator_full_name>Rachel Pechey</investigator_full_name>
    <investigator_title>Senior Research Associate</investigator_title>
  </responsible_party>
  <!-- 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/NCT03252158
org study id: PRE.2017.029
nct id: NCT03252158
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: While there is some evidence that increasing the range of healthier foods and
      drinks and/or decreasing the range of less healthy options may increase healthier choices,
      more work is needed to establish the reproducibility of any effect. The current study aims to
      investigate the impact of altering the availability of healthier and less healthy foods and
      cold beverages in hospital vending machines.

      Methods: An adapted multiple treatment reversal design will be used, in which all standard
      vending machines serving snack foods and/or cold beverages in one hospital in England change
      the number of slots containing (i) less healthy items and (ii) healthier items over eight
      4-week periods. Changes will take place in a two-step process whereby decreases are
      implemented in a separate study period prior to increases in the contrasting food group.
      Following a 4-week baseline period, all vending machines will be standardised to have 75%
      healthier drinks and/or 25% healthier snacks (study period 1). Vending machines (n=9) will be
      randomly allocated to the order in which they: (1) decrease less healthy foods and increase
      healthier foods or (2) decrease healthier foods and increase less healthy foods (study
      periods 2&3 and 5&6). After each decrease-increase pair, machines will return to the
      standardised 75% healthier drinks and 25% healthier snacks (study periods 4 and 7). Sales
      data will be obtained via records of machine restocking.

      Planned Analysis: The impact of the availability intervention will be assessed in separate
      linear mixed models for cold drinks and snacks, examining the impact on total energy (kcal)
      purchased, per restocking interval, with random effects for vending machine.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: An adapted multiple treatment reversal design will be used, in which the number of slots containing (i) less healthy items and (ii) healthier items are altered over eight 4-week periods.
Vending machines will be randomly allocated to one of two groups: (1) decreasing less healthy foods first or (2) decreasing healthier foods first.
primary purpose: Basic Science
masking: None (Open Label)
measure: Energy purchased
time frame: Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)
description: Energy purchased (kcal) per restocking interval from intervention (standard-fare) vending machines
measure: Number of items sold
time frame: Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)
description: Number of items sold per restocking interval from intervention (standard-fare) vending machines
measure: Energy purchased (healthier alternative machines)
time frame: Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)
description: Energy purchased (kcal) per restocking interval from non-intervention (healthier-fare) vending machines
measure: Number of items sold (healthier alternative machines)
time frame: Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)
description: Number of items sold per restocking interval from non-intervention (healthier-fare) vending machines
arm group label: Decrease less healthy item availability
arm group type: Experimental
description: Intervention: Availability of healthier vs. less healthy foods
Remove less healthy items in 20% of slots, then fill the empty slots with healthier items.
arm group label: Decrease healthier item availability
arm group type: Experimental
description: Intervention: Availability of healthier vs. less healthy foods
Remove healthier items in 20% of slots, then fill the empty slots with less healthy items.
intervention type: Behavioral
intervention name: Availability of healthier vs. less healthy foods
description: Altering the number of slots containing (a) healthier and (b) less healthy foods or beverages in hospital vending machines.
Changes follow a 2-step process whereby decreases are implemented in a separate study period prior to increases in the contrasting group. Following a 4-week baseline period, all vending machines will be standardised to have 75% healthier drinks and/or 25% healthier snacks (study period 1). Vending machines will be randomly allocated to the order in which they: (1) decrease less healthy foods and increase healthier foods or (2) decrease healthier foods and increase less healthy foods (study periods 2&3 and 5&6). After each decrease-increase pair, machines will return to the standardised 75% healthier drinks / 25% healthier snacks (study periods 4 and 7).
arm group label: Decrease healthier item availability
arm group label: Decrease less healthy item availability
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel Pechey, PhD
role: Principal Investigator
affiliation: University of Cambridge
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Cambridge
investigator full name: Rachel Pechey
investigator title: Senior Research Associate