- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03431051
The Impact of Workplace Food and Beverage Choices on Health and Wellness
August 10, 2022 updated by: Jamey Schmidt, California Pacific Medical Center Research Institute
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
648
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- California Pacific Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Healthy Beverage Initiative
A Healthy Beverage Initiative and health education will be implemented at two hospital campuses.
|
A Healthy Beverage Initiative will be instituted at two hospital campuses.
|
|
NO_INTERVENTION: Control Arm
No change in beverages or education at two hospital campuses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
About one year.
|
|
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.
|
About one year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
About one year.
|
|
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).
|
About one year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Greg Tranah, PhD, Sutter Health-California Pacific Medical Center Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 18, 2018
Primary Completion (ACTUAL)
November 30, 2021
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
January 29, 2018
First Submitted That Met QC Criteria
February 9, 2018
First Posted (ACTUAL)
February 13, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 12, 2022
Last Update Submitted That Met QC Criteria
August 10, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Healthy Beverage Initiative
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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