Health and WellnessNCT03431051
The Impact of Workplace Food and Beverage Choices on Health and Wellness
A study testing Healthy Beverage Initiative in people with Health and Wellness, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health and Wellness
- What is being tested?
- Healthy Beverage Initiative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- The participant is planning an extended leave of absence and/or family medical leave of absence over the next 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Pacific Medical Center
San Francisco, California, 94115
About this study
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.
Read the 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?
- Conditions
- Health and Wellness
- Being tested
- Healthy Beverage Initiative
- Keywords
- Healthy Beverage Initiative, Sugar Sweetened Beverages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Beverage InitiativeOther
A Healthy Beverage Initiative will be instituted at two hospital campuses.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Beverage Initiative | Active comparator | A Healthy Beverage Initiative and health education will be implemented at two hospital campuses. Receives: Other: Healthy Beverage Initiative |
| Control Arm | No intervention | No change in beverages or education at two hospital campuses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal adiposity
Study participants at HBI campuses will show improvements (specifically, decreases) in indices of abdominal adiposity measured using waist circumference in centimeters.
Measured: About one year.
Abdominal adiposity
Study participants at HBI campuses will show improvements (specifically, decreases) in indices of abdominal adiposity measured using sagittal abdominal diameter in centimeters.
Measured: About one year.
Secondary outcomes (2)
Body Mass Index (BMI)
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.
Measured: About one year.
Sugar Sweetened Beverage Intake
Study participants at HBI campuses will show improvements (specifically, decreases) in SSB intake measured by the BEVQ (beverage food frequency questionnaire).
Measured: About one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start18 Jan 2018
- Primary completion30 Nov 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health and WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 648 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Laura and John Arnold Foundation, University of California, San Francisco
- Responsible party
- Principal investigator, Jamey Schmidt, California Pacific Medical Center Research Institute
- Investigators
- Greg Tranah, PhD, Study director, Sutter Health-California Pacific Medical Center Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431051
- Sponsor's protocol ID
- Healthy Beverage Initiative
- Status last verified
- Aug 2022
- First submitted
- 29 Jan 2018
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Workplace Food and Beverage Choices on Health and Wellness
- ClinicalTrials.gov ID
- NCT03431051
- Acronym / sponsor ID
- Healthy Beverage Initiative
- Conditions
- Health and Wellness
- Keywords
- Healthy Beverage Initiative, Sugar Sweetened Beverages
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 648 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- Laura and John Arnold Foundation, University of California, San Francisco
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Beverage Initiative | Active comparator | Other: Healthy Beverage InitiativeA Healthy Beverage Initiative and health education will be implemented at two hospital campuses. |
| Control Arm | No intervention | –No change in beverages or education at two hospital campuses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- The participant is planning an extended leave of absence and/or family medical leave of absence over the next 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Beverage InitiativeA Healthy Beverage Initiative will be instituted at two hospital campuses. | Other | Healthy Beverage Initiative |
Primary outcome
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.
2 secondary outcomes
Body Mass Index (BMI)
Time frame: About one year.
Sugar Sweetened Beverage Intake
Time frame: About one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Tranah, PhD study director
Sutter Health-California Pacific Medical Center Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Beverage Initiative in people with Health and Wellness, run by California Pacific Medical Center Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal adiposity (time frame: About one year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.