xml: <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/NCT05972109</url>
    </required_header>
    <id_info>
      <org_study_id>22-38247</org_study_id>
      <secondary_id>R01DK132870</secondary_id>
      <nct_id>NCT05972109</nct_id>
    </id_info>
    <brief_title>Metabolic Health Improvement Program: Effects of a Workplace Sugary Beverages Sales Ban and Motivational Counseling</brief_title>
    <acronym>MHIP</acronym>
    <official_title>Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational Counseling Intervention on Adiposity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sutter Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>California Pacific Medical Center Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Francisco</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>
        The purpose of the study is to test the impact of a multilevel workplace intervention&#xD;
        (hospital-wide sales ban on sugar-sweetened beverages (SSBs) and individual-level brief&#xD;
        counseling) on employee health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This double-randomized controlled trial of a multilevel workplace intervention that combines&#xD;
        an employer-sponsored sales ban on sugar-sweetened beverages (SSBs) with brief counseling to&#xD;
        support reduced consumption will test how well each intervention works alone, whether they&#xD;
        work better in combination than separately, and whether or not changes in SSB cravings&#xD;
        mediate these effects. Sutter Health worksites will be randomly assigned to either a control&#xD;
        condition or to implement a sales ban on SSBs. Within all sites, employees will be randomized&#xD;
        to receive/not receive a brief counseling intervention focused on reducing SSB consumption.&#xD;
        Participants will complete self-report questionnaires, give blood samples, and provide&#xD;
        measurements of waist circumference, height, and weight. These data will be analyzed to&#xD;
        determine the effects of the interventions, both separately and in combination.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</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>Factorial Assignment</intervention_model>
      <intervention_model_description>The study is a double-randomized, controlled trial of 700 Sutter Health employees working at 16 hospital campuses. The hospital campuses will be randomized to sales ban or control. After screening employees at the 16 campuses for heavy SSB consumption (&gt; 30 oz/week), the investigators will further randomize study participants to receive the brief counseling intervention or not. This will result in a balanced design of n=175 participants in each cell of a 2x2 factorial design: 1) sales ban alone; 2) behavioral counseling alone, 3) combined condition of sales ban and behavioral counseling, and 4) no intervention or control condition. This is an efficient design for testing the effects of the sales ban and brief counseling interventions plus their cross-level interaction within a context of full randomization.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>The study is a double-randomized, controlled trial of 700 Sutter Health employees working at 16 hospital campuses. The hospital campuses will be randomized to sales ban or control. After screening employees at the 16 campuses for heavy SSB consumption (&gt; 30 oz/week), the investigators will further randomize study participants to receive the brief counseling intervention or not.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Abdominal Adiposity (Waist Circumference)</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>Waist circumference in centimeters (using method from Multi-Ethnic Study of Atherosclerosis). The study will measure the change between baseline and 12 month Abdominal Adiposity measurements.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Insulin Sensitivity (HOMA)</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>Insulin sensitivity will be calculated using the homeostatic model assessment (HOMA). The equation for HOMA is fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. The study will measure the change between baseline and 12 month HOMA.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Body Mass Index (BMI)</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>Body Mass Index [BMI] measured using height in centimeters and weight in kilograms to be calculated into BMI. The study will measure the change between baseline and 12 month BMI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Quantity of SSB Consumption</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>Fluid ounces of SSB consumed per day using Automated Self-Administered Dietary Assessment Tool (ASA-24) and Beverage Intake Questionnaire (BEV-Q). The study will measure the change between baseline and 12 month SSB consumption quantity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Lipid Profile Measurements</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>HDL, LDL, total cholesterol, triglycerides, and triglycerides:HDL ratio (calculated). The study will measure the change between baseline and 12 month individual lipid profile measurements (E.g., HDL, LDL, total cholesterol, triglycerides, and triglycerides:HDL ratio).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ApoB Levels</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>Blood level of ApoB. The study will measure the change between baseline and 12 month ApoB blood levels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Fasting insulin Levels</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>Fasting blood level of insulin. The study will measure the change between baseline and 12 month Fasting insulin blood levels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Fasting Glucose Levels</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>Fasting blood level of glucose. The study will measure the change between baseline and 12 month Fasting Glucose blood levels.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in Uric Acid Levels</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>Blood level of Uric Acid. The study will measure the change between baseline and 12 month Uric Acid blood levels.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in HbA1C Levels</measure>
      <time_frame>Baseline and 12 Months</time_frame>
      <description>Blood Level of HbA1C. The study will measure the change between baseline and 12 month HbA1C blood levels.</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">700</enrollment>
    <condition>Obesity, Abdominal</condition>
    <condition>Insulin Sensitivity</condition>
    <arm_group>
      <arm_group_label>Control: No workplace SSB sales ban, no brief intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants receive no workplace SSB sales ban (environmental intervention) and no brief counseling intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Workplace SSB sales ban only</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Brief intervention only</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Multilevel Intervention (workplace SSB sales ban + brief intervention)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sales ban: Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options.&#xD;
  Brief Intervention: Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Workplace SSB sales ban</intervention_name>
      <description>Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.</description>
      <arm_group_label>Multilevel Intervention (workplace SSB sales ban + brief intervention)</arm_group_label>
      <arm_group_label>Workplace SSB sales ban only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Brief Intervention</intervention_name>
      <description>Participants receive single-session brief intervention, which is an intervention that uses motivational interviewing, and helps participants understand amount and effect of their baseline SSB intake, identify realistic goals for reduction and overcoming obstacles.</description>
      <arm_group_label>Brief intervention only</arm_group_label>
      <arm_group_label>Multilevel Intervention (workplace SSB sales ban + brief intervention)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Full-time employee who works on campus at one of the Sutter Health participating sites&#xD;
  &#xD;
            -  Speaks and reads English&#xD;
  &#xD;
            -  Consumes three or more sugar-sweetened beverages (SSB) a week&#xD;
  &#xD;
            -  Agrees to participate in two fasting blood draws&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant&#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>Laura A Schmidt, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Elissa Epel, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jamey Schmidt</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sutter Health/California Pacific Medical Center Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sweet Study Contact</last_name>
      <phone>415-600-5848</phone>
      <email>sweet@sutterhealth.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sutter Health/California Pacific Medical Center Research Institute</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94115</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jamey M Schmidt, RD</last_name>
        <phone>415-600-1182</phone>
        <email>jamey.schmidt@sutterhealth.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin Resistance</mesh_term>
      <mesh_term>Obesity, Abdominal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 10, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT05972109/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 10, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT05972109/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972109
  org study id: 22-38247
  secondary id: R01DK132870
  nct id: NCT05972109
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to test the impact of a multilevel workplace intervention
        (hospital-wide sales ban on sugar-sweetened beverages (SSBs) and individual-level brief
        counseling) on employee health.
  This double-randomized controlled trial of a multilevel workplace intervention that combines
        an employer-sponsored sales ban on sugar-sweetened beverages (SSBs) with brief counseling to
        support reduced consumption will test how well each intervention works alone, whether they
        work better in combination than separately, and whether or not changes in SSB cravings
        mediate these effects. Sutter Health worksites will be randomly assigned to either a control
        condition or to implement a sales ban on SSBs. Within all sites, employees will be randomized
        to receive/not receive a brief counseling intervention focused on reducing SSB consumption.
        Participants will complete self-report questionnaires, give blood samples, and provide
        measurements of waist circumference, height, and weight. These data will be analyzed to
        determine the effects of the interventions, both separately and in combination.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: The study is a double-randomized, controlled trial of 700 Sutter Health employees working at 16 hospital campuses. The hospital campuses will be randomized to sales ban or control. After screening employees at the 16 campuses for heavy SSB consumption (> 30 oz/week), the investigators will further randomize study participants to receive the brief counseling intervention or not. This will result in a balanced design of n=175 participants in each cell of a 2x2 factorial design: 1) sales ban alone; 2) behavioral counseling alone, 3) combined condition of sales ban and behavioral counseling, and 4) no intervention or control condition. This is an efficient design for testing the effects of the sales ban and brief counseling interventions plus their cross-level interaction within a context of full randomization.
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: The study is a double-randomized, controlled trial of 700 Sutter Health employees working at 16 hospital campuses. The hospital campuses will be randomized to sales ban or control. After screening employees at the 16 campuses for heavy SSB consumption (> 30 oz/week), the investigators will further randomize study participants to receive the brief counseling intervention or not.
  measure: Change in Abdominal Adiposity (Waist Circumference)
  time frame: Baseline and 12 Months
  description: Waist circumference in centimeters (using method from Multi-Ethnic Study of Atherosclerosis). The study will measure the change between baseline and 12 month Abdominal Adiposity measurements.
  measure: Change in Insulin Sensitivity (HOMA)
  time frame: Baseline and 12 Months
  description: Insulin sensitivity will be calculated using the homeostatic model assessment (HOMA). The equation for HOMA is fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. The study will measure the change between baseline and 12 month HOMA.
  measure: Change in Body Mass Index (BMI)
  time frame: Baseline and 12 Months
  description: Body Mass Index [BMI] measured using height in centimeters and weight in kilograms to be calculated into BMI. The study will measure the change between baseline and 12 month BMI.
  measure: Change in Quantity of SSB Consumption
  time frame: Baseline and 12 Months
  description: Fluid ounces of SSB consumed per day using Automated Self-Administered Dietary Assessment Tool (ASA-24) and Beverage Intake Questionnaire (BEV-Q). The study will measure the change between baseline and 12 month SSB consumption quantity.
  measure: Change in Lipid Profile Measurements
  time frame: Baseline and 12 Months
  description: HDL, LDL, total cholesterol, triglycerides, and triglycerides:HDL ratio (calculated). The study will measure the change between baseline and 12 month individual lipid profile measurements (E.g., HDL, LDL, total cholesterol, triglycerides, and triglycerides:HDL ratio).
  measure: Change in ApoB Levels
  time frame: Baseline and 12 Months
  description: Blood level of ApoB. The study will measure the change between baseline and 12 month ApoB blood levels.
  measure: Change in Fasting insulin Levels
  time frame: Baseline and 12 Months
  description: Fasting blood level of insulin. The study will measure the change between baseline and 12 month Fasting insulin blood levels.
  measure: Change in Fasting Glucose Levels
  time frame: Baseline and 12 Months
  description: Fasting blood level of glucose. The study will measure the change between baseline and 12 month Fasting Glucose blood levels.
  measure: Change in Uric Acid Levels
  time frame: Baseline and 12 Months
  description: Blood level of Uric Acid. The study will measure the change between baseline and 12 month Uric Acid blood levels.
  measure: Change in HbA1C Levels
  time frame: Baseline and 12 Months
  description: Blood Level of HbA1C. The study will measure the change between baseline and 12 month HbA1C blood levels.
  arm group label: Control: No workplace SSB sales ban, no brief intervention
  arm group type: No Intervention
  description: Participants receive no workplace SSB sales ban (environmental intervention) and no brief counseling intervention.
  arm group label: Workplace SSB sales ban only
  arm group type: Experimental
  description: Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options.
  arm group label: Brief intervention only
  arm group type: Experimental
  description: Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.
  arm group label: Multilevel Intervention (workplace SSB sales ban + brief intervention)
  arm group type: Experimental
  description: Sales ban: Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options.
  Brief Intervention: Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.
  intervention type: Other
  intervention name: Workplace SSB sales ban
  description: Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.
  arm group label: Multilevel Intervention (workplace SSB sales ban + brief intervention)
  arm group label: Workplace SSB sales ban only
  intervention type: Behavioral
  intervention name: Brief Intervention
  description: Participants receive single-session brief intervention, which is an intervention that uses motivational interviewing, and helps participants understand amount and effect of their baseline SSB intake, identify realistic goals for reduction and overcoming obstacles.
  arm group label: Brief intervention only
  arm group label: Multilevel Intervention (workplace SSB sales ban + brief intervention)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Laura A Schmidt, Ph.D
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Elissa Epel, Ph.D
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Jamey Schmidt
  role: Principal Investigator
  affiliation: Sutter Health/California Pacific Medical Center Research Institute
  last name: Sweet Study Contact
  phone: 415-600-5848
  email: sweet@sutterhealth.org
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Insulin Resistance
  mesh term: Obesity, Abdominal
  sharing ipd: No
  provided document: 
  provided document: 