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The Impact of Workplace Food and Beverage Choices on Health and Wellness

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ClinicalTrials.gov Identifier: NCT03431051
Recruitment Status : Active, not recruiting
First Posted : February 13, 2018
Last Update Posted : May 13, 2021
Sponsor:
Collaborators:
Laura and John Arnold Foundation
University of California, San Francisco
Information provided by (Responsible Party):
Jamey Schmidt, California Pacific Medical Center Research Institute

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE February 13, 2018
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • Abdominal adiposity [ Time Frame: About one year. ]
    Study participants at HBI campuses will show improvements (specifically, decreases) in indices of abdominal adiposity measured using waist circumference in centimeters.
  • Abdominal adiposity [ Time Frame: About one year. ]
    Study participants at HBI campuses will show improvements (specifically, decreases) in indices of abdominal adiposity measured using sagittal abdominal diameter in centimeters.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • Body Mass Index (BMI) [ Time Frame: About one year. ]
    Study participants at HBI campuses will show improvements (specifically, decreases) in body mass index [BMI] measured using height in centimeters and weight in kilograms to be calculated into BMI in kg/m^2.
  • Sugar Sweetened Beverage Intake [ Time Frame: About one year. ]
    Study participants at HBI campuses will show improvements (specifically, decreases) in SSB intake measured by the BEVQ (beverage food frequency questionnaire).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Workplace Food and Beverage Choices on Health and Wellness
Official Title  ICMJE The Impact of Workplace Food and Beverage Choices on Health and Wellness
Brief Summary The study is designed to determine if instituting a Healthy Beverage Initiative (HBI) at hospitals influences health and wellness of employees over a 12 month period.
Detailed Description To examine whether HBI is associated with decreased adiposity over a 12-month time period, in comparison to individuals identically assessed but not exposed to a HBI. Specifically, do those exposed to the HBI decrease in measures of adiposity, BMI, and sugar sweetened beverage (SSB) intake? Do they decrease more in those measures as compared to those not exposed to the HBI?
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Health and Wellness
Intervention  ICMJE Other: Healthy Beverage Initiative
A Healthy Beverage Initiative will be instituted at two hospital campuses.
Study Arms  ICMJE
  • Active Comparator: Healthy Beverage Initiative
    A Healthy Beverage Initiative and health education will be implemented at two hospital campuses.
    Intervention: Other: Healthy Beverage Initiative
  • No Intervention: Control Arm
    No change in beverages or education at two hospital campuses.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 27, 2020)
648
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
700
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The participant speaks and reads English.
  • The participant consumes three or more sugar-sweetened beverages a week.
  • The participant expects to be able to participate for all 3 visits (baseline, 6 months, and 12 months).

Exclusion Criteria:

The participant is planning an extended leave of absence and/or family medical leave of absence over the next 12 months.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03431051
Other Study ID Numbers  ICMJE Healthy Beverage Initiative
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jamey Schmidt, California Pacific Medical Center Research Institute
Study Sponsor  ICMJE California Pacific Medical Center Research Institute
Collaborators  ICMJE
  • Laura and John Arnold Foundation
  • University of California, San Francisco
Investigators  ICMJE
Study Director: Greg Tranah, PhD Sutter Health-California Pacific Medical Center Research Institute
PRS Account California Pacific Medical Center Research Institute
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP