Obesity, AbdominalMHIPNCT05972109
Metabolic Health Improvement Program: Effects of a Workplace Sugary Beverages Sales Ban and Motivational Counseling
A study testing Workplace SSB sales ban and Brief Intervention in people with Obesity, Abdominal and Insulin Sensitivity, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Insulin Sensitivity
- What is being tested?
- Workplace SSB sales ban and Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Feb 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Full-time employee who works on campus at one of the Sutter Health participating sites
- Speaks and reads English
- Consumes three or more sugar-sweetened beverages (SSB) a week
- Agrees to participate in two fasting blood draws
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Sutter Health/California Pacific Medical Center Research Institute
San Francisco, California, 94115
About this study
Official title: Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational Counseling Intervention on Adiposity
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.
Read the detailed description
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.
- Conditions
- Obesity, Abdominal, Insulin Sensitivity
- Being tested
- Workplace SSB sales ban, Brief Intervention
- Medical subject headings
- Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workplace SSB sales banOther
Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.
Brief InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control: No workplace SSB sales ban, no brief intervention | No intervention | Participants receive no workplace SSB sales ban (environmental intervention) and no brief counseling intervention. |
| Workplace SSB sales ban only | Experimental | 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. Receives: Other: Workplace SSB sales ban |
| Brief intervention only | Experimental | 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. Receives: Behavioral: Brief Intervention |
| Multilevel Intervention (workplace SSB sales ban + brief intervention) | Experimental | 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. Receives: Other: Workplace SSB sales ban; Behavioral: Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Abdominal Adiposity (Waist Circumference)
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.
Measured: Baseline and 12 Months
Change in Insulin Sensitivity (HOMA)
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.
Measured: Baseline and 12 Months
Secondary outcomes (6)
Change in Body Mass Index (BMI)
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.
Measured: Baseline and 12 Months
Change in Quantity of SSB Consumption
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.
Measured: Baseline and 12 Months
Change in Lipid Profile Measurements
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).
Measured: Baseline and 12 Months
Change in ApoB Levels
Blood level of ApoB. The study will measure the change between baseline and 12 month ApoB blood levels.
Measured: Baseline and 12 Months
Change in Fasting insulin Levels
Fasting blood level of insulin. The study will measure the change between baseline and 12 month Fasting insulin blood levels.
Measured: Baseline and 12 Months
Change in Fasting Glucose Levels
Fasting blood level of glucose. The study will measure the change between baseline and 12 month Fasting Glucose blood levels.
Measured: Baseline and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Dec 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sutter Health, California Pacific Medical Center Research Institute
- Responsible party
- Sponsor
- Investigators
- Laura A Schmidt, Ph.D, Principal investigator, University of California, San FranciscoElissa Epel, Ph.D, Principal investigator, University of California, San FranciscoJamey Schmidt, Principal investigator, Sutter Health/California Pacific Medical Center Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972109
- Sponsor's protocol ID
- 22-38247
- Other IDs
- R01DK132870
- Acronym
- MHIP
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational Counseling Intervention on Adiposity
- ClinicalTrials.gov ID
- NCT05972109
- Acronym / sponsor ID
- MHIP / 22-38247
- Conditions
- Obesity, Abdominal, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sutter Health, California Pacific Medical Center Research Institute
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 2 Aug 2023 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control: No workplace SSB sales ban, no brief intervention | No intervention | –Participants receive no workplace SSB sales ban (environmental intervention) and no brief counseling intervention. |
| Workplace SSB sales ban only | Experimental | Other: Workplace SSB sales banParticipants 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 only | Experimental | Behavioral: Brief InterventionParticipants 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. |
| Multilevel Intervention (workplace SSB sales ban + brief intervention) | Experimental | Other: Workplace SSB sales ban, Behavioral: Brief InterventionSales 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Full-time employee who works on campus at one of the Sutter Health participating sites
- Speaks and reads English
- Consumes three or more sugar-sweetened beverages (SSB) a week
- Agrees to participate in two fasting blood draws
Key exclusion criteria (1 listed)
- Pregnant
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 |
|---|---|---|
| Workplace SSB sales banEnvironmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus. | Other | Multilevel Intervention (workplace SSB sales ban + brief intervention), Workplace SSB sales ban only |
| Brief InterventionParticipants 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. | Behavioural | Brief intervention only, Multilevel Intervention (workplace SSB sales ban + brief intervention) |
Primary outcome
Change in Abdominal Adiposity (Waist Circumference)
Time frame: Baseline and 12 Months
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.
Change in Insulin Sensitivity (HOMA)
Time frame: Baseline and 12 Months
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.
6 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline and 12 Months
Change in Quantity of SSB Consumption
Time frame: Baseline and 12 Months
Change in Lipid Profile Measurements
Time frame: Baseline and 12 Months
Change in ApoB Levels
Time frame: Baseline and 12 Months
Change in Fasting insulin Levels
Time frame: Baseline and 12 Months
Change in Fasting Glucose Levels
Time frame: Baseline and 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Laura A Schmidt, Ph.D principal investigator
University of California, San Francisco
Elissa Epel, Ph.D principal investigator
University of California, San Francisco
Jamey Schmidt principal investigator
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 Workplace SSB sales ban and Brief Intervention in people with Obesity, Abdominal and Insulin Sensitivity, run by University of California, San Francisco 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 4 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: finished, as of the sponsor's last update on 23 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Abdominal Adiposity (Waist Circumference) (time frame: Baseline and 12 Months). 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 23 Feb 2026.