Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational Counseling Intervention on Adiposity
Phase: NA
Conditions: Obesity, Abdominal, Insulin Sensitivity
Sponsor: University of California, San Francisco

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cover Page for Protocol Summary Form 
 
 
Official Study Title: 
Multi-Level Trial of a Workplace Sales Ban 
of Sugary Beverages and Brief Motivational 
Counseling Intervention on Adiposity 
NCT Number: 
NCT ID not yet Assigned. 
Document Date: 
July 10, 2023 
 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
1
Project Title:  Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational 
Counseling Intervention on Adiposity.  The Sweet Study 
 
 
Principal Investigator:   Jamey M. Schmidt, RD 
 
Primary Sutter Contact Information: 
Name: Jamey M. Schmidt 
Email:  jamey.schmidt@sutterhealth.org 
Phone Number: 415-238-7823 
 
Protocol Summary Version Date:  6.30.2023 
 
 
PART I:  General Study Information 
 
► Is there a separate protocol document (for example, an external study sponsor has supplied the 
protocol) that explains the study purpose, background/significance, inclusion/exclusion criteria, and 
data analysis/methods? 
☐ Yes  
 
Include protocol document with IRB application and skip to Part II.* 
☒ No     
Complete Part I and the rest of the form. 
 
 
* In some cases, parts of the sponsor protocol will NOT be implemented at your site (for example, if the sponsor 
protocol allows for enrollment of minors but you will only be enrolling adults; or if the protocol is phase 1/2 but you 
will only be implementing the phase 2 part). If this is the case or there are other planned deviations from the 
sponsor protocol, please explain in the space provided in [Part IV: Other Comments] of this form. 
 
 
►Note: If completing the below (Part I: General Study Information #1-7), please delete guidelines (in italics) 
when submitting your protocol to IRB. 
 
1. 
STUDY AIM/PURPOSE:  
“Liquid sugar” in the form of sugar-sweetened beverages (SSBs, e.g., sodas, sports drinks, “fruit” 
drinks, bottled teas, coffees) has emerged as a dietary risk factor with potent harmful effects on 
metabolic health.1-3 SSBs are the largest single source of added sugars in the American diet, and have 
disproportionate metabolic health impacts on lower-income and ethnic-minority Americans.4,5  We 
propose a double-randomized controlled trial of a multilevel workplace intervention that combines an 
employer-sponsored sales ban on SSBs with brief counseling to support reduced consumption. 
After decades of research, it is clear that there is no single “magic bullet” for obesity prevention.  
However, bundled interventions that combine incremental changes in food environments with targeted 
behavioral interventions motivating healthier food choices show great promise.6  The workplace 
provides an efficient venue to intervene.  Rising obesity- and diabetes-related healthcare costs 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
2
incentivize employers to invest in prevention if workplace interventions are found to be effective, 
efficient, and scalable.   
 
Health systems and schools are increasingly adopting SSB sales bans, wherein employers stop 
selling SSBs in all cafeterias and vending outlets and replace them with healthier options.   Employer-
based brief counseling interventions, despite being low-cost and efficacious for alcohol and tobacco 
reduction, have received limited attention as an approach to reduce SSB consumption.7-10  A multilevel 
intervention may be the most effective because it combines a counseling intervention that increases 
motivation to reduce or quit SSBs with a sales ban that removes environmental triggers and cues.  In our 
pilot study of 214 heavy SSB drinkers followed for 10 months,11 a workplace sales ban on its own 
reduced waist circumference by 2.1 cm.  The sales ban alone also led to an 8.2 oz/day decline in SSB 
consumption which correlated with increased insulin sensitivity.  However, employees who received 
brief counseling, in addition to exposure to the sales ban, experienced more pronounced declines in SSB 
consumption.11  And employees with strong SSB cravings benefitted more from the multilevel 
intervention, drinking 16.7 oz/day less than comparable controls.12    
 
To assess the effectiveness of this multilevel intervention, called the workplace Metabolic Health 
Improvement Program (MHIP), we will conduct a double-randomized trial in partnership with the clinical 
trials division of a large Northern California-based academic healthcare system, Sutter Health (N=700 
employees on N=16 hospital campuses).  We will first cluster-randomize 8 Sutter Health hospital 
campuses to the SSB sales ban condition and 8 campuses to serve as controls (no sales ban).  Across 
these 16 campuses, we will further randomize heavy-SSB-consuming employees (>30 oz/week) to 
receive a brief SSB counseling intervention delivered remotely or to a control condition.11,12  The primary 
outcomes are central obesity (e.g., waist circumference) and change in serum insulin sensitivity 
(homeostatic model assessment [HOMA] ratio).  Secondary outcomes include changes in SSB 
consumption, Body Mass Index (BMI), and lab values to include: lipid profile, triglycerides, 
triglyceride:HDL ratio, uric acid, ApoA, ApoB, lactate, ALT/AST, GGT, fasting glucose, fasting insulin, 
HbA1c.  We will assess dietary composition remotely using the Automated Self-Administered 24-hour 
(ASA-24) at baseline, 6 and 12 months, and waist circumference remotely with empirically validated 
instructions and a standardized tape measure provided to participants.  We will collect blood samples in 
the workplace labs at baseline and 12 months.  All analyses will consider compensatory changes in at-
home SSB intake, calories from sugar, and total calories.  Aims are: 
 
 
Aim 1: How well does each intervention work alone?  We will assess the independent effects of the 
brief counseling intervention and workplace SSB sales ban on changes in primary and secondary 
outcomes.  We will compare outcomes across employees exposed to the brief intervention only 
(n=175), SSB sales ban only (n=175), and no intervention (n=175).  We hypothesize that the brief 
counseling intervention and sales ban will each independently decrease waist circumference and HOMA 
relative to no intervention.  Those at high risk (baseline BMI >25, ethnic-minority, and lower-
occupational status) will benefit more from the interventions. 
 
 
Aim 2: Does a multilevel intervention work better?  We will assess the effects of combining a brief 
intervention and SSB sales ban on outcomes.  We will compare outcomes for participants exposed to 
the multilevel intervention (n=175) to those who receive the: (a) brief intervention only (n=175), (b) 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
3
sales ban only (n=175), and (c) no intervention (n=175).  We hypothesize that the combined intervention 
will have a greater effect on outcomes than the brief intervention or sales ban alone. Higher-risk 
employees (see Aim 1) will benefit more from the multilevel intervention than their lower-risk 
counterparts. 
 
 
Aim 3: (Exploratory): How does the intervention work?  We will test whether changes in SSB cravings 
mediate the effects of the multilevel intervention on outcomes.  The multilevel intervention seeks to 
increase motivation to reduce SSB intake while reducing environmental cues to drink SSBs.  We 
hypothesize that the multilevel intervention will lead to the greatest reductions in cravings for SSBs, and 
cravings will mediate its effects on outcomes.  We will explore mediation across high-risk groups (see 
Aim 1). 
 
 
2. 
BACKGROUND:  
 
 
Obesity and type 2 diabetes are pressing health concerns, particularly for lower-income and 
ethnic minority employees.  Obesity rates are at an all-time high and disparities persist: 49.6% of adult 
African Americans are currently obese and 44.8% of Latinos, compared to 42.2% of non-Hispanic 
whites.13  Diabetes rates have nearly doubled since 2000.14  Employers face disproportionately rising 
obesity-related healthcare costs alongside productivity losses.15 Obesity is major concern for 
occupational safety, particularly for physically active nurses, manual workers and technicians at 
heightened risk for injury.15,16  
 
 
Sugar-sweetened beverages (SSBs) are a key target for obesity prevention. SSBs lack nutrition and 
are the largest contributor of added sugars in the American diet.17-19  Sugar from beverages is rapidly 
digested, promoting hyperinsulinemia and insulin resistance.1  Recent metanalyses establish dose-
response relationships between SSB consumption and obesity, abdominal adiposity, hypertension and 
diabetes.20,21 Systematic reviews find that an increase of one SSB serving per day increases the risk of 
obesity by 12%,21 diabetes by 18%,20 coronary heart disease by 17%,1 and hypertension by 8%.22  Among 
the working-age population, SSBs are the top dietary factor associated with cardiometabolic mortality.2  
Adults gain from one-half to one pound annually for every 8 oz of SSBs in the diet.23  Despite these 
known health harms, reducing SSB consumption is difficult because sugar is highly palatable and triggers 
dopaminergic craving.24  
 
 
The workplace is an ideal place to site obesity prevention programs but to expand access, we need to 
“lower the bar” for participation.  Adults spend most of their waking hours in the workplace, providing 
an efficient place and mechanism to intervene in obesity.  Yet currently, American workplaces 
contribute to the problem.  Foods and beverages purchased in the workplace are generally higher in 
added sugars than those available at home,25-27 with SSBs purchased the most.28  Common obesity 
interventions involving extended coaching in diet and fitness can be effective for weight loss.29-32  But 
they disproportionately benefit employees with more flexible time and resources, thus selecting for 
higher status, more motivated, employees.33,34  This reinforces health disparities35-37 and undercuts the 
employer’s return on investment.33   
 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
4
Pilot Study of Multilevel Intervention: Published in JAMA Internal Medicine, the pilot study examined 
the effectiveness of a brief SSB motivational counseling intervention in the context of a workplace sales 
ban in 214 UCSF employees (with a retention rate of 94% after 10 months).11 The sample was drawn 
from a larger online survey of a representative sample of 2556 UCSF employees (see immediately 
below), where the baseline occurred 3 months prior to implementation of a sales ban.  Employees who 
reported heavy consumption of SSBs on the baseline survey were randomized to receive the brief 
counseling intervention or the control condition (sales ban only). All participated in anthropometric and 
fasting blood draws prior to the sales ban and 10 months after. Across both the multilevel and sales-ban 
only conditions, study participants experienced a 2.1 cm reduction in waist circumference, as well as 
decreases in uric acid and HDL cholesterol. Regression analyses, controlling for baseline BMI, insulin 
sensitivity (HOMA) and gender, found that this reduction in SSB consumption predicted a statistically 
significant reduction in HOMA. Those exposed to the multilevel intervention reported more pronounced 
reductions in SSB intake than the sales ban only group (25.4 oz vs. 8.2 oz, p < .001). Moreover, those 
with a >25 baseline BMI benefitted most and also experienced statistically significant reductions in lipids 
(total and LDL cholesterol, and ApobB).11  This pilot study was underpowered and lacked a non-
intervention control group, which the proposed study will address. Still, it demonstrates our ability to 
administer the brief counseling intervention and suggests that the multilevel intervention has a beneficial 
impact on metabolic health, particularly for people with a BMI >25.  
 
 
Online Data Collection Evaluating UCSF Sales Ban: Observational data from an online survey of 2556 
UCSF employees suggests that higher-risk demographic groups could disproportionately respond to the 
proposed intervention. Sample retention in this online study was 89% at the 12-month follow-up. Ethnic 
minority employees were twice more likely to report heavy consumption at baseline. Latinos 
experienced a more pronounced decline following the sales ban than Whites (by -3.7oz/day, p<.007). 
The lowest occupation stratum (service/manual workers) experienced a 30% reduction in consumption 
compared to 13% in the highest occupational group (academic medicine faculty) (p<.0001). While 
limited by an observational approach, this study supports our proposed analyses by ethnic minority and 
lower occupational status, and speaks to our capacity for online data collection with good retention. 
 
Pilot Study of SSB Craving as a Mechanism: A published analysis of the UCSF pilot data found variable 
responses to the interventions for those with stronger SSB cravings (+1 SD above sample mean at 
baseline).12  Individuals with weaker (-1 SD) SSB cravings reduced their SSB consumption, on average, by 
12.8 oz/day (p=.02) more than individuals with stronger SSB cravings. However, among those with 
stronger cravings, those randomized to the multilevel intervention had significantly greater reductions in 
daily consumption (-19.21 oz/day vs. -2.49 oz/day, p<.001), a difference of 16.72 oz/day. This study 
informs analyses proposed under Aim 3 by suggesting that employees with stronger SSB cravings may 
need the added motivational boost of brief counseling to achieve benefits on a par with others.  
 
 
Current Controlled Trial of Workplace Sales Ban in Sutter Health: In partnership with Sutter Health, we 
are currently completing a fully powered controlled trial of workplace SSB sales bans across 8 hospital 
campuses (5 intervention sites and 3 controls, N=657 employees), funded by the Laura and John Arnold 
Foundation. Retention was 88% at 6 months and 78% at 12 (during the COVID-19 pandemic). Collection 
of anthropometrics for this controlled trial was interrupted by the pandemic, but we continue to collect 
dietary assessments and other data using an online format. At 6-months post-sales ban, there is a 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
5
statistically significant mean reduction of 4.2 oz/day in SSB consumption in employees at intervention 
sites versus controls (p<.04), including a 2.7 oz/day reduction in SSBs consumed while at work (p <0.02). 
This study is not cluster-randomized nor does it consider serum biomarkers for metabolic disease, which 
the proposed study will address. However, it demonstrates a successful collaboration with Sutter Health, 
and shows the feasibility of the proposed recruitment and remote data collection efforts. 
 
3. 
SIGNIFICANCE:  
 
The proposed study tests a scalable, efficient approach for obesity prevention in the workplace. 
Following recent trials demonstrating the effectiveness of online obesity counseling using nonmedical 
providers, we test a remote counseling intervention delivered by trained health coaches.38,39 The SSB 
sales ban is a food environment intervention that is easily adopted through changes in procurement 
policy and that promotes health equity by impacting the workforce as a whole. 
  
Across all aims of the proposed study, we will assess the heterogeneity of intervention effects across 
higher-risk employee groups from ethnic minority backgrounds, lower occupational status and >25 
baseline BMI.  A recognized limitation of this study is that our disparities analyses will be confined to 
people in the workforce.  If the interventions tested here prove effective, however, future studies can 
test them in other congregate settings that touch populations outside the labor market (e.g., in criminal 
justice settings, community colleges). 
 
 
Brief SSB counseling interventions are promising but underutilized for obesity prevention. Brief 
interventions are short (~15 minute) counseling sessions that use motivational interviewing to offer 
advice and set goals to modify health behaviors. They are the standard of care for tobacco and alcohol 
prevention, with diverse applications in primary care,7 emergency rooms,8 and trauma centers,9 and are 
effective when delivered by nonmedical providers (e.g., probation officers,10 college counselors40). 
Despite this track record, brief interventions have not been widely deployed in obesity prevention.  Our 
literature review found only four smaller-scale studies examining the effectiveness of brief motivational 
interventions for SSB reduction.41-44  All found that telephone or online brief counseling, with booster 
contacts using text messages or mobile apps, produce significant declines in SSB consumption and/or 
BMI.  Under Aim 1, we will conduct the first fully powered trial of brief counseling for SSB reduction in the 
context of a large employer. 
 
 
 
 
Workplace SSB sales bans have promise for obesity prevention, but studies are limited.  A sales ban 
entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage 
options while still allowing employees to bring SSBs from home.  Informed by behavioral economics, 
sales bans are designed to “nudge” employees towards healthier options,44,45 while reducing the 
environmental cues and triggers that drive hedonic consumption.46  There is robust prior research 
demonstrating that workplace sales bans on tobacco lead to declines in consumption and broader 
normative shifts.48-52  Thus, a growing number of health systems, health departments, city governments, 
schools and universities have launched SSB sales bans.53 54-58  But evaluations are limited with as yet no 
published controlled trials.59-61 In an observational study of 2556 employees, we found that a sales ban 
resulted in an average decline in employee SSB consumption of 1.5 oz/day.12  In a subsequent 
microsimulation analysis, we estimated that SSB sales bans could save employers about $300,000 per 
10,000 employees over 10 years in healthcare savings and productivity gains.62  Our proposed Aim 1 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
6
analyses will contribute new knowledge by testing the effectiveness of sales bans using anthropometrics 
and blood biomarkers in the first fully-powered randomized controlled trial. 
 
 
Our preliminary studies suggest that brief SSB counseling interventions and workplace sales bans 
could be potentially synergistic with respects to obesity prevention:  The proposed trial leverages 
multiple levels of the socioecological model in mutually-reinforcing ways.63  While the sales ban intends 
to reduce availability, and the environmental cues associated with SSBs in the workplace, the brief 
intervention provides employees with a motivational boost to cut down or quit.  In our UCSF pilot study 
of heavy SSB drinkers, all were exposed to a sales ban and half were randomized to a brief motivational 
counseling intervention.  We found that the combined effects led to reductions in SSB consumption of 
24 oz/day compared to an 8 oz/day reduction for employees exposed to the sales ban alone (see 
“Preliminary Studies”).11,12  This pilot study, however, was not fully powered or able to test the brief 
intervention in the absence of a sales ban. Under Aim 2, we will pursue the hypothesis that reduced SSB 
availability and cues under a sales ban, combined with the motivational boost of a brief intervention, will 
optimize outcomes. 
 
 
Exploring mechanisms of change. The NIH Common Fund is spearheading the Science of Behavior 
Change (SoBC) Initiative to urge scientists to explore the mechanisms of action in behavior change 
interventions, thus promoting the cumulative advancement of science.64  The SoBC model (see Figure 2 
below) allows scientists to systematically explore the “how and why” behind changes in obesogenic 
behaviors, thus contributing to the development of blueprints for more effective obesity prevention.  
Our pilot study found that employees who reported drinking SSBs due to strong cravings did not benefit 
from the sales ban alone.12  But if those who received the brief intervention reduced their consumption 
by over 19 oz/day. SSB cravings could, therefore, be a mechanism on the critical pathway leading from 
the multilevel intervention to changes in central obesity (see “Preliminary Studies”).  If the multilevel 
intervention proves to be effective, mediation analyses proposed under Aim 3 will help shed light on why.  
If not effective, they will help us to build future interventions that are more effective. 
 
Public health impact: If effective, the proposed employer-sponsored multilevel intervention will offer an 
efficient, scalable strategy for preventing obesity in millions of American working adults.  This study will 
also contribute to science on mechanisms of change in obesity prevention and inform the design of 
interventions that exploit synergies between individual behavior change strategies and food 
environment policies. 
 
 
4. 
METHODS:  
 
 
(4a) General Study Design:   
This is a prospective, double-randomized study in which 16-Sutter Health affiliate hospital campuses will be 
cluster randomized to control (no SSB sales ban) vs. intervention (removal of SSBs).  Across these 16 
campuses, we will enroll 700 employees and then randomize those who self-report consuming >30 oz of 
SSB per week to receive a brief counseling intervention or control (no intervention). 
 
 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
7
 
(4b) Procedures:  
 
Cluster Randomization of 16 Sutter Health Affiliates 
Sutter Health affiliates will be eligible to participate in the study who meet the criteria:  1) the affiliate 
has not participated in a SSB intervention; 2) the affiliate is not in a county that has instituted a SSB sales 
tax.  Affiliates will be stratified by their location (urban vs. rural) and number of employees and will be 
randomly assigned using a computer program to be assigned to either control or intervention.  Sutter 
Health leadership (James Conforti and Conrad Vial, MD) have signed a letter of support to conduct this 
study. 
 
Sites randomized to the SSB will eliminate sugar-sweetened beverages from the cafeterias, vending 
machines, Walgreens, vendors, and from patient care areas.   Sutter Health has already implemented 
Healthy Beverage Initiatives (HBI) at Alta Bates, Palo Alto Medical Foundation (PAMF) and all CPMC 
campuses.   
 
 
Study Procedure 
Description 
Baseline 
6 Months 
12 Months 
Informed Consent 
Procedures Described Below 
X 
 
 
Demographics 
Self-reported gender, ethnicity, 
household income, education, work 
location, hours, shifts 
X 
X 
X 
Medical History 
Self-reported concurrent medications 
and general medical history with an 
emphasis on diabetes 
X 
X 
X 
Height 
Measured using a stadiometer on a 
standardized scale at a semi-private 
location on the affiliate campus. 
X 
 
 
Weight 
Obtained on a standardized scale at a 
semi-private location on the affiliate 
campus. 
X 
X 
X 
Waist Circumference 
A tape measure with instructions will 
be provided to the participant to 
measure at the designated timepoints. 
X 
X 
X 
Fasting Blood Draw 
The collection will include:  complete 
metabolic and lipid panel, uric acid, 
ApoB, GGT, glucose, insulin, HbA1c.  
These are biomarkers that are risk 
factors for poor metabolic health, 
diabetes, and cardiovascular disease 
X 
 
X 
BevQ 
This questionnaire seeks to quantify the 
frequency, type and volume of 
beverages consumed at work and 
home.   
X 
X 
X 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
8
ASA 24 
This is a web-based, 24-hour dietary 
recall tool developed by the National 
Cancer Institute 
X 
X 
X 
Stanford Leisure Time 
Scale (L-CAT) 
This is a scale that measures physical 
activity. 
X 
X 
X 
*PROMIS4a Depression 
Assesses the presence and severity of 
symptoms of depression. 
X 
X 
X 
Beverage Craving 
Questionnaire  
(FCQ-T-R) 
Assesses the following:  1) 
preoccupation with sweetened 
beverages; 2) loss of control; 3) positive 
outcome expectancy; 4) emotional 
cravings 
X 
 
 
Reward Based Eating 
Drive (RED-13) 
Assesses three aspects of drive to eat: 
1) loss of control; 2) lack of satiety; 3) 
preoccupation with food 
X 
X 
X 
Perceived Stress Scale 
This is a widely used questionnaire to 
assess stress levels.  It evaluates the 
degree to which an individual has 
perceived life as unpredictable, 
uncontrollable, and overloading over 
the previous month.   
X 
X 
X 
Copenhagen Burnout 
Inventory (CBI) 
This six-item inventory measures 
personal burnout experienced by 
participants. 
x 
x 
x 
Self-Efficacy 
These questions are used to determine 
if an individual exhibits intention to 
reduce SSB consumption. 
X 
X 
X 
Science of Behavior 
Change Texts  
Parent Grant 
Assesses craving, psychological stress, 
consumption and self-efficacy (two 
texts/day x four days/week) 
X 
X 
X 
Science of Behavior 
Change Texts 
Supplemental Grant 
Assesses craving, psychological stress, 
consumption and self-efficacy (two 
texts/day x four days/week) 
Additional texts will be sent at the 
following time periods: 
1, 2, and 3 months after SSB 
intervention.   
EPIC EMR 
Lab results from the blood draw will be 
extracted from EPIC utilizing the 
resources of the Center for Health 
Services Research (CHSR).  Limited data 
from the medical record will be 
extracted by CHSR that looks at 
metabolic health. 
X 
 
X 
Incentive Gift 
 
X 
X 
X 
 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
9
*Patient-Reported Outcomes Measurement Information System (PROMIS): We have selected a self-
report measures of depression which are person-centered which all study participants will be asked to 
complete. We will investigate the possible correlation between SSB consumption, general health and 
depression as well as change over time between the intervention and control campuses. Subjects who 
report high levels of depression will be provided with contact information to Sutter Health’s Employee 
Assistance Program (EAP).  No documentation will be placed in the subject’s medical or employment 
record.  
 
REDCap will be set-up with a notification alerting the CRCs when the depression scores result with 
severe depression. When the participant completes their questionnaires, the Clinical Research 
Coordinators will review the depression questionnaire.  If a participant scores a severe depression 
(score, a phone call will be made to the participant using a script.  A form has been created and will be 
used as documentation.  This includes a script for leaving a message and for a live call.  During a live call 
only, the Clinical Research Coordinator will inform the participant of their high score and will with the 
phone number to Sutter Health’s EAP.   
 
Demographics: Including gender, ethnicity, primary work location, occupational status, income, 
and usual number of worked shifts each week will be recorded via REDCap. 
 
Medical History: Concurrent medications and general medical history will be obtained directly 
from study participants with an emphasis on metabolic history such as diabetes.  Data will be 
recorded via REDCap 
 
Height, weight, and waist circumference measurements: Subjects will be asked to record their 
self-reported height in REDCap.  Height and weight will be measured using a standard scale with 
an attached stadiometer in a semi-private location at the affiliate and record their weight and 
height in REDCap.  A tape measure and instructions on measuring waist will be sent to the 
participant’s home.  They will record the measurement in REDCap. 
 
Fasting Blood Draw:  A fasting blood draw will take place at the draw station of the local affiliate.  
Labs will be drawn at baseline and at 12-months.  The panels will be comprised of metabolic and 
lipid panels that pertain to metabolic syndrome.  Labs will be accessible to participants using My 
Health Online. 
 
Medical Record:  Medical record data will be requested for the Sutter EHR (Epic) over a seven-
year period (to include one year prior to enrollment, the 12-month study period and for five years 
thereafter).  Data collection will include metabolic parameters related to obesity, such as:  lipid 
panels, glucose, insulin, liver panels, height, weight, and past and prospective history.  Medical 
records data collection will include medication history, progress reports, discharge summaries, 
and other data allowing us to look at the long-term impact of metabolic health in this population.   
 
Depression:  We will investigate the possible correlation between SSB consumption, general 
health and depression as well as change over time between the intervention and control 
campuses.  

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
10
 
Benefits: In cooperation with SutterSelect, we will obtain aggregate claim information for subjects 
at the intervention and control campuses. The aim of this data is to evaluate differences in health 
plan costs between the two groups. No individual health claims information will be collected. The 
data access form will review the security and privacy controls to ensure protections are in place.  
This data will be collected one year prior to enrollment, the 12-month study period and five years 
after. 
 
Questionnaires: Subjects will complete all questionnaires remotely using a secure instance of 
REDCap. 
 
 
BEVQ:  BEVQ is a food frequency questionnaire measuring specific beverage items.  We will use 
an adapted version of the BEV-Q field tested in the UCSF studies that captures beverage 
consumption while in the workplace and while not at work. The questions ask the type and 
frequency of consuming specific types of beverages on a typical day: regular/non-diet soda, diet 
soda, 100% fruit juice, fruit drinks (lemonade, smoothies), sports or energy drinks, sweetened 
coffee or tea drinks (Arizona iced tea, Frappucinos), and water. Participants also report how much 
(in ounces) they consume of each beverage each time over a limited, one week, recall period. 
Daily intake can be calculated for each beverage type by multiplying the frequency and serving 
size 
 
The Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24):  The ASA24 is a 
free, web-based tool that enables multiple, automatically coded, self-administered 24-hour diet 
recalls and/or single or multi-day food records.  ASA24 was developed by the National Cancer 
Institutes. Participants will be asked to complete one 24-hour recall at enrollment, 6 and 12 
months using a link and password sent to them.   
 
The Stanford Leisure-Time Categorical Item (L-CAT):  The L-CAT is a questionnaire asking 
participants to rank their activity level from inactive to very active.  This tool has been validated 
and can detect statistical differences when used over time.   
 
 
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression:  The 
PROMIS Depression 4-item questionnaire banks assess self-reported negative mood (sadness, 
guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal 
alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and 
purpose). The depression short forms are universal rather than disease specific. All assess 
depression over the past seven days. If they score in the severe range the Clinical Research 
Coordinators will contact the participant and will provide them with the EAP contact information 
and will encourage them to call EAP.   
 
 
Food Craving Questionnaire-Trait, Reduced (FCQ-T-r): The 15-item FCQ-T-R assesses (1) 
preoccupation with SSB (i.e., obsessive thought about food and eating), (2) loss of control (i.e., 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
11
difficulty regulating eating behavior when exposed to food cues), (3) positive outcome expectancy 
(i.e., believing eating to be positively reinforcing), and (4) emotional craving (i.e., tending to crave 
food when experiencing negative emotion). 
 
Reward Based Eating Drive (Red-13): The 13-item RED assesses three aspects of drive to eat (loss 
of control, lack of satiety, and preoccupation with food). Items are answered on a Likert scale 
from 0 (Strongly Disagree) to 5 (Strongly Agree). Example items include "I feel out of control in 
the presence of delicious food" and "When I start eating, I just can't seem to stop." 
 
             Copenhagen Burnout Inventory (CBI):  The 6-item portion of the CBI assess personal burnout as  
is a state of prolonged physical and psychological exhaustion.  Participants quantity the frequency 
of physical and emotional fatigue, as well as their susceptibility to illness, from on a six-point scale 
from “Always” to “Never”. Formulated in a way that all human beings can answer it (regardless 
of job status), the measure was validated through the PUMA study. 
 
             
Participant Randomization 
Upon completion of five enrollment measurements (questionnaires, height/weight, waist, ASA24, and 
blood draw) participants will be randomly assigned to either a control group, or a group receiving a 
brief, remote motivational intervention, known as the Metabolic Health Improvement Plan 
(MHIP).  Participants are randomized by a REDCap randomization module, using stratified random 
sampling by location.  Those randomized to intervention will be contacted as described below. 
 
 
SSB Brief Motivational Counseling Intervention- The Health Improvement Program  
Participants randomly assigned to the health improvement program and will be contacted to participate 
in an education session with a trained coach via phone or video conference.  The session led by a trained 
coach will describe the amount of sugar ingested in SSBs per week and will then proceed to provide 
personal guidance on health risks and the benefits of reducing sugar intake.  Next, the coach will engage 
the participant in achievable, gradual goals to reduce SSB consumption reviewing and providing 
education materials.  This will include discussing substitution beverages and preferred alternatives.  
Coaches will provide tools to the participate to increase self-efficacy and mediate the impact of stress, 
and cravings.  The brief counseling session ends with the coach providing education materials including 
recordings relevant to the discussion, which can include topics of stress reduction and mindfulness.  
Depending on the participant, the brief intervention will take between 15 and 25 minutes to complete.   
 
The coach will make two, 5-minute booster telephone calls within 4-6 weeks of the initial call. The first 
will be about two weeks after the initial session and the second call will be about two weeks later.  The 
coach will revisit goals and obstacles and determine compliance to the educational materials.   
 
Elissa Epel, PhD and Rachel Radin, PhD will supervise the training of Sutter Health externs/interns who 
are seeking hours towards their graduate education.  Interns will meet the following minimum 
requirements: psychologist trainees enrolled in a masters-level or doctoral-level American Psychology 
Association accredited graduate program, with a minimum of 1 year of prior supervised clinical/clinical 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
12
research experience, interest in Motivational Intervention and/or health psychology, and ability to 
commit to 6 months of this practicum opportunity.  Training sessions will include mock sessions until 
coaches are comfortable and proficient with the intervention.  To assure a high degree of fidelity with 
the registered intervention protocol, 20% of counseling sessions will be recorded and reviewed by Dr. 
Radin.  During these observations, she will record any breeches with protocol and other guidance using 
a standard checklist.  Checklist data will be collated during analysis to capture an overall assessment of 
fidelity in implementation of the clinical protocol.   
 
Dr. Radin and the externs will be onboarded at Sutter Health to work on this project using one of two 
methods:   
 
Method 1:  Dr. Radin and the externs will be onboarded as a volunteer.  Dr. Radin will lead the training 
and will review the coaching sessions.   
Method 2:  Dr. Radin and the externs will be onboarded as paid interns. 
 
To communicate with the participants, the externs/interns will utilize a Sutter Health TEAMS or ZOOM 
approved for PHI use.  It is preferred that either method will have recording capabilities.  In the event 
they do not, a Sutter Health approved encrypted audio recorder will be used.   
 
Recordings will be saved in a folder on a Sutter Health drive only accessible by research team members. 
 
 
SSB Cravings and Stress Text Based Data Collection  
Using the Ecological Momentary Assessment (EMA) approach, cravings will be measured by study 
participants using smart phones.  Using the REDCap platform, participants will receive a short set of 
questions at the following timepoints:  baseline, 1, 2, and 3 months after SSB intervention starts at 
randomized affiliates, and 6 and 12-months.  Two texts will be sent each day (morning and evening) four 
of the seven days of the week.  Participants will be asked to quickly record the following: cravings (if any) 
for sugar sweetened beverages, psychological stress, consumption, and psychological stress. The primary 
target for this exploratory analysis is cravings for SSBs but we will also have access to information on 
whether or not subjects consumed SSBs in response to the craving.  Each text should take one to-five 
minutes each.  The content of the text is as follows: 
- 
Introductory text at the start of each assessment period (Sunday afternoon) shall read:  
o Greetings Sweet Study Participant – this week, we’ll text you 4 clickable links in 
the morning and 4 in the evening on Tues, Thurs, Fri, and Sat. Each link will take 
1-5 minutes to complete – Short and Sweet! The week after you finish the 
surveys, we’ll email you a $10 gift code. Please complete at least 6 of the 8 texts 
in order to receive a gift code. 
 
Each day, the texts will be labeled as morning Sweet text 1, 2, 3, 4 and evening Sweet text 
1, 2, 3, 4.   
 
Location (asked in evening) 
 
Today, were you physically working at your Sutter Health workplace?  

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
13
- 
Yes 
- 
No 
 
Can define a sugary drink here.  
 
Craving Battery – Evening – Supplement and Parent 
1. Today, did you crave a sugary drink?  Yes / No  
·         If No, skip #2 and #3    
·         If Yes: Move on to #2.   
  
2. At its most severe point, how strong was your craving for a sugary drink today?  
 
Sliding bar, slider starting at middle or optimally nowhere and it gets placed when the 
respondent touches the screen, if starting in the middle then movement of bar required to 
advance to next question  
 
*For #3, make these checkboxes, with the first two non-exclusive, and the “no” exclusive 
3. Did you drink anything in response to ANY of these cravings?   
• 
Yes, a sugary drink  
• 
Yes, water, a sugar-free drink, or a drink with no added sugar 
• 
No 
 
Psychological Stress Battery - Evening – Supplement and Parent 
What was your overall mood like during the day? 
1. I felt stressed, anxious, overwhelmed. 
2. I felt joyful, glad, happy. 
3. I felt in control, coping well, on top of things. 
4. I felt sad, downhearted, unhappy. 
  
Scale:  
0 = Not at all 
1 = A little bit  
2 = Somewhat      
3 = Moderately    
4 =Extremely 
 
Consumption Battery – Evening, last item administered – Supplement  
1. Thinking back on how much sugary drinks you had today, which is most true for you:  
 
Response options: Assessment 1 (baseline) 
- 
I drank less than I usually do 
- 
I drank about as much as I usually do 
- 
I drank more than I usually do  
 
Response options: Assessment 2 and beyond  
(1-month post-Ban and all further assessments) 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
14
- 
I drank less than I usually did before the Sweet study 
- 
I drank about as much as I usually did before the Sweet study 
- 
I drank more than I usually did before the Sweet study 
 
Self-Efficacy Battery – Morning 
If going to work:  
1) How sure are you that you will avoid drinking sugary drinks today while at your Sutter Health 
workplace? 
 
Not sure at all ---------- Extremely sure  
 
Sliding bar, slider starting at middle or optimally nowhere and it gets placed when the 
respondent touches the screen, if starting in the middle then movement of bar required to 
advance to next question  
 
 Don’t know 
 I don’t plan to go to my Sutter Health workplace today 
 
2) How sure are you that you will avoid drinking sugary drinks today while not at your Sutter 
Health Workplace? 
[1] Not sure at all 
[2]  
[3] Somewhat sure 
[4] 
[5] Extremely sure 
 I do not drink sugary drinks 
 Don’t know 
 
 
Blood Draw 
The orders for the blood draw will be signed off by Nisha S. Patel, MD the study physician.  Results will be 
sent to patients via My Health Online.  The study participants will be asked to review out of range labs 
with their primary care physician 
 
 
  
(4c) Methods of Data Analysis:   
 
Analysis Plan for Aim 1: How well does each intervention work alone? We will assess the independent 
effects of the brief counseling intervention and workplace SSB sales ban on changes in primary and 
secondary outcomes. 
 
Introduction: Aim 1 analyses will compare primary and secondary outcomes for employees exposed to 
the brief intervention only, the SSB sales ban only, and no intervention. Our operative hypothesis is that 
both the brief counseling intervention and sales ban will independently decrease HOMA and waist 
circumference relative to no intervention. Of four smaller studies testing the effects of brief SSB 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
15
counseling interventions, all found decreases in SSB consumption and BMI.41-44  A pilot study and current 
trial by this team found that workplace sales bans reduce SSB consumption, waist circumference and 
some blood biomarkers for metabolic disease.11   
 
Analyses for all aims will also consider the hypothesis that those at highest risk for obesity and 
metabolic disease will benefit more from the interventions. This is justified by our pilot study showing 
that employees with a baseline BMI <25 benefitted most from the sales ban and brief intervention.11 
Preliminary studies (described above) suggest that ethnic minority and lower occupational status 
employees may experience disproportionate reductions in SSB consumption following an employer sales 
ban.   
 
Analyses for all aims will also consider the possibility that study participants exposed to the 
interventions could compensate for reduced SSB consumption during work hours by increasing their 
consumption of SSBs at home, or by increasing calories from sugary foods or in the total diet.107,108 In our 
evaluation of the UCSF sales ban, we observed no compensatory at-home SSB consumption but rather, 
spillover effects of the intervention:  After 12 months of exposure to a sales ban, the average SSB intake 
of heavy drinkers not only declined at work but also by 40% at home (by 9.3 oz/day) (data unpublished). 
 
Research Design for Aim 1: The main analysis will focus on ANOVA and regression modeling to 
determine the independent effects of each intervention on primary and secondary outcomes. 
 
Key Measures for Aim 1: As described in section C3d above: HOMA, waist circumference, 
abdominal adiposity, SSB consumption, insulin sensitivity, BMI, lipid profile, triglycerides, 
triglycerides:HDL ratio, liver function, glucose control, demographics, risk factors/disparities, and 
intervention assignment.  
        Analytic Plan: We will analyze Aim 1 using all data collected at the baseline, 6- and 12-month time 
points.  First, we will use ANOVA to compare group means and determine whether there is a significant 
main effect for each intervention (the sales ban and the brief intervention).  Based on theory and our 
previous studies, we know that baseline risk factors and demographics are likely relevant to the impact 
of these interventions; those at greater baseline risk tend to benefit more from the interventions. 
Therefore, each dependent variable will also be examined using a linear regression model, which allows 
us to observe the main effects of these factors. For example, the model predicting HOMA change would 
include assignment to the sales ban condition (coded as 0/1), assignment to the brief intervention 
condition (coded as 0/1), baseline HOMA, baseline SSB consumption, baseline BMI, race/ethnicity, and 
sex. Subsequent models can consider baseline BMI > 25, ethnicity and job classification. The procedure 
for analyzing each outcome would be the same, but with each primary and secondary outcome 
substituted for HOMA in turn.  
 
For SSB consumption, we will examine at-work consumption, at-home consumption, and total 
consumption as separate outcomes to thoroughly investigate the impact of the interventions across 
work and home environments.  We will similarly check for potential compensatory consumption in sugar 
from calories and total calories for participants in the intervention conditions relative to controls. If ASA-
24-based total calories or calories from sugar disproportionately increase in the intervention groups, this 
suggests a compensatory effect. 
 
Although we believe our strategy of cluster randomization and controlling for individual 
differences that can vary regionally (such as ethnic distribution) is sufficient, we will also analyze the 
effects of the brief intervention via an exploratory mixed regression model, with individuals nested 
within sites, to see if study site was an important factor. If it is, we will consider mixed models where 
possible. 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
16
 
Power Calculations: Power calculations are based on changes observed in the pilot study and 
response rates from the current Sutter Health trial.  Calculations are conservative, based on 80% 
retention of participants after 12 months. With an initial N of 700 drawn from 16 Sutter Health sites 
randomly assigned to the sales ban and control conditions, and with participants within those sites 
randomly assigned to brief intervention/no brief intervention conditions, 80% retention would result in 
an overall N of 550 at 12 months.  This results in approximately 138 in each of four experimental 
conditions: brief intervention + sales ban, the brief intervention only, sales ban only, and no 
intervention.  Power analysis for a full factorial design conducted with the BDEsize109 package within R110 
indicates that with 80% power and an alpha level of .05, we will be able to detect effect sizes as small as 
.08 for the effect of each intervention on each outcome.   
 
Anticipated Problems and Alternative Approaches: One potential problem is attrition, 
particularly biased attrition. We have calculated the sample to allow for up to 20% attrition; this is a 
conservative number based on our current Sutter Health data. In the UCSF pilot, which took place 
entirely pre-pandemic, we achieved a 94.4% response rate for blood draws. The existing study team has 
experience with the challenges of retaining a sample of health care workers during a challenging time 
and can use the same techniques (e.g., email and phone outreach) to reduce attrition here. We will 
conduct statistical tests to determine if attrition is biased on baseline risk levels, demographic factors 
(including regional differences), or study condition.  
 
As with all self-report data, the survey data on SSB consumption could be biased, perhaps 
particularly for intervention participants who want to self-present improvement.  However, the 
anthropometric and blood measures are objective and should show a consistent pattern with the SSB 
changes. Standard data cleaning procedures should reveal any extreme cases of self-representation bias. 
For SSB consumption data, we have also established a convention in previous studies of pruning outliers 
that are more than 4 SD away from the mean to reduce error from participants who may have 
responded inaccurately. 
We have several primary and secondary outcomes.  To avoid bias from multiple statistical tests, we 
will closely examine patterns of data. Many of the biomarkers are related, for example, as are the 
anthropometric measurements. Thus, it will be apparent whether or not each result is consistent with 
the overall pattern of health impacts. 
 
Expected Outcomes: We expect statistically significant main effects for both study condition 
variables in the ANOVA analysis, specifically that the means for each of the three groups exposed to the 
sales ban and/or brief interventions will demonstrate more improvement (reduction in HOMA, 
abdominal adiposity, blood lipids, SSB consumption, BMI, etc.) than those in the group receiving neither 
intervention. We also anticipate statistically significant coefficients for each study condition variable in 
the regression analysis that again indicates that those interventions are linked to better outcomes.  This 
would indicate that each intervention has an effect. 
 
Analysis Plan for Aim 2: Does a multilevel intervention work better? We will assess the multilevel effects 
of combining a brief intervention and SSB sales ban on outcomes. 
 
 
Introduction: The goal of Aim 2 is to test the hypothesis that the combined intervention will have a 
greater effect on outcomes than the brief intervention or sales ban alone. This is justified by our pilot 
study findings that employees benefitted most from the multilevel intervention (see Figure 1)11 and by 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
17
the socioecological model which argues that obesity prevention should address multiple levels of 
intervention at once.99 
 
Research Design for Aim 2: The analysis will use ANOVA and regression models similar to those 
above, but with the key addition of an interaction term for the two interventions, allowing us to explore 
the possibility that they work better in combination than separately. 
 
Key Measures for Aim 2. Measures are the same as those described above under Aim 1. 
 
Analytic Plan for Aim 2: Having established the main effects of each intervention under Aim 1, 
our analyses for Aim 2 focus on the interaction between them. Specifically, we anticipate that the 
combined intervention will have an effect above and beyond the simple additive effects of the two 
interventions. This analysis will require replicating the ANOVA and regression models used for Aim 1 
with the addition to each of an interaction term for the two interventions. For example, the model 
predicting HOMA change will include assignment to the sales ban condition (coded as 0/1), assignment 
to the brief intervention condition (coded as 0/1), the interaction term for the two conditions (sales 
ban*brief intervention), baseline HOMA, baseline SSB consumption, baseline BMI, race/ethnicity, job 
classification (if sample size allows, as above), and sex. The procedure for analyzing each outcome is the 
same, but with each primary and secondary outcome substituted for HOMA in turn. This time, the main 
variable of interest will be the interaction term.  We will graph and deconstruct each significant 
interaction term to determine the details of the interaction. 
 
Power Calculations: As with Aim 1 above, power calculations are based on findings from the 
UCSF pilot and retention rates from the Sutter pilot. We will have 175 participants in each of the 
following groups. With 80% retention, this allows a final N of 550, with approximately 138 in each of the 
four experimental conditions. Power analysis for a full factorial design conducted with the BDEsize109 
package within R110 indicates that at 80% power and an alpha level of .05 we will be able to detect effect 
sizes as small as .12 for the interaction between the two interventions.  
 
Anticipated Problems and Alternative Approaches: As with Aim 1, attrition and self-report bias 
are the primary potential issues we anticipate; handling of each is described above.  
 
Expected Outcomes: We anticipate a significant interaction term, and more specifically, that the 
effect of the sales ban and brief intervention together will be stronger than each is individually. 
Participants assigned to the brief intervention and working at sites with a sales ban would thus 
demonstrate the greatest amount of change, and more change than one would expect if the effect of 
the two conditions were simply additive.  
 
 
Analysis Plan for Aim 3: (Exploratory): How does the intervention work? We will test whether changes in 
SSB craving mediate the effects of the multilevel intervention on outcomes.  
 
 
 
Introduction: The goal of this analysis is to examine SSB craving as a mediator in the relationship 
between the multilevel intervention and primary and secondary health outcomes. This is justified by our 
pilot study analysis showing that employees with a high level of baseline craving benefited more from 
the multilevel intervention than comparable employees exposed to the sales ban alone.12  This study is 
designed to test the mediation model for the sales ban and brief intervention separately, helping us to 
understand the “active ingredients” in the multilevel intervention. We can also explore differential 
benefits for members of high-risk groups. 
 
Research Design for Aim 3: This exploratory analysis will estimate mixed effects using logistic 
regression models. In contrast to some approaches toward mediation analysis (e.g.,111-114), ours will 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
18
simultaneously test all paths, including indirect effects through the mediator,112-114 regardless of the 
presence of a statistically significant total intervention effect.114  Available measures allow us to examine 
the extent that changes in SSB cravings and SSB consumption after cravings mediate the effects of the 
multilevel intervention on outcomes. 
 
Key Measures for Aim 3: In addition to measures described above, this aim incorporates text 
message-based EMA data that captures SSB cravings in the context of day-to-day life.  
 
Analytic Plan for Aim 3: Participants will respond to a question asking if they experienced a 
craving for SSBs as yes or no. We will use this SSB craving variable (M), along with group assignment (X), 
to predict 12-month SSB consumption (Y). This simultaneous mediation model will comprise, first, a 
mixed effects logistic regression model (Path A in Figure 2 above, from X to M). This model will include 
random effects for day nested within study period, nested within person for each of the possible reports 
per day (morning, afternoon, evening, and “any other time not previously reported”). The dependent 
variable will be the dichotomous primary outcomes reflecting the experience of a craving or whether a 
craving was acted upon. Model covariates (fixed effects) include time of day, study period, 
randomization group, and the interaction of study period by randomization group. This will allow us to 
estimate the odds of having a craving or indulging in one at 6- and 12-months compared to baseline, 
separately for each experimental arm, as well as allowing for direct comparisons between study arms at 
each time point.  
 
A second component of the model is a mixed effects linear regression model (Path B in Figure 2 
above, from M to Y) that links a change in cravings between baseline and the 6-month follow up 
(measured as the change in the proportion of responses in which subjects reported cravings) to SSB 
consumption and HOMA at 12 months. We will perform this mediation model first without covariates115 
and then will perform it with other predictors of SSB consumption (e.g., demographics, high-risk group) 
as in Aim 1. This analysis will allow us to estimate the proportions of variance in SSB consumption at 12 
months that are related to changes in SSB craving experiences.  
 
The relationship between the interventions and SSB consumption without the inclusion of 
craving (Path C) will have already been established in the analyses for Aims 1 and 2, so lastly, we will 
examine Path C’ (interventions predicting consumption and waist change with the inclusion of the 
craving mediator). This will necessitate a model similar to those used in Aims 1 and 2, but with the 
addition of craving change and an interaction term for intervention*craving change.  
 
Anticipated problems and Alternative Approaches: This is an exploratory analysis, and thus 
may not be able to detect very small mediation effects. However, based on our pilot analysis with a 
much smaller sample, we do not anticipate this will be an issue.  The same caveats about retention and 
self-report bias described in the Aim 1 analysis plan also apply here.   
 
Expected Outcomes: We anticipate that participants in the multilevel intervention group will 
have a greater reduction in cravings than those in the sales ban or brief intervention groups alone and 
no intervention groups. We also anticipate that a greater reduction in cravings will be associated with 
greater reduction in SSB consumption and HOMA at 12 months.  
 
 
(4d) Subject Selection:  
 
Inclusion Criteria: 
1. Full-time employee who works on campus at one of the 16 Sutter Health participating sites. 
2. English speaking. 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
19
3. Reports drinking >3 SSBs/week. 
4. Agrees to having two fasting blood draws. 
 
 
Exclusion Criteria: 
1. Pregnant  
 
 
5.     RISKS/DISCOMFORTS 
Blood Draw:  there is a risk of pain, bruising, and/or infection at the needle stick site.  This is minimal risk. 
 
Confidentiality:  there is a risk of loss of confidentiality which is minimal.  Controls are in place as described in 
the data access plan to collect data in Sutter Health applications. 
 
6.    ALTERNATIVES 
Employees can choose not to participate. 
 
7. 
BIBLIOGRAPHY:  
See Attached:  Literature Cited 
 
 
 
 
PART II:  Subject Recruitment and Consent 
 
► Does your study involve recruiting, obtaining consent or any other kind of subject 
intervention/interaction? (This means research-related activity that involves any contact with 
participants, even a minimal intervention such as an anonymous survey.) 
  
☒ Yes  
 
Complete all of [Part II: Subject Recruitment and Consent] below  
(“1. Recruitment” and “2. Consent”). 
☐ No* 
 
   
 
Skip [Part II: Subject Recruitment and Consent] and go to [Part III: Waiver of 
Informed Consent]. 
* Answer “no” and skip to [PART III:  Waiver of Informed Consent] if your study 
involves ONLY data collection without consent or without any other interaction 
with study participants.  
 
 
1. RECRUITMENT 
A. Please indicate your prospective subject pool (check all that apply): 
☐  Patients from Sutter Health investigators’ own medical practice at Sutter 
☐  Patients from Sutter Health entities but outside investigators’ own medical practice 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
20
☒  Sutter Health workforce members  
☐  Sutter Health physicians 
☐  Non- Sutter Health Patients 
☐  Other (please explain):            
 
B. What method(s) will be used to identify potential participants for the study (check all that apply)? 
☐  Patient clinic visit 
☐  Physician/provider (non-investigator) referral  
☐  Database search. If checked, please answer the following: 
 
       (i)   Please identify all databases(s) that will be used (e.g., EPIC):       
 
(ii)  Who will be conducting the data search (e.g., PI, CRC, data steward?):        
☐ Patient (or other potential participant) response to advertisement/solicitation. If checked, please 
indicate type of solicitation (check all that apply): 
☐  MyHealthOnline (MHO) message 
☒  Email (other than via MHO) 
☒  Advertisement (flyers, radio/TV/social media, sponsor or other study website) 
☒  Other (please explain): see below 
 
C. Recruitment Procedures: After potential participants are identified (via methods explained under B 
above), what will be the procedures for making initial contact to follow-up and initiate further 
recruitment and consent? Please provide a narrative of all procedures, in chronological, step-by-step 
fashion (starting with how potential subjects’ contact information will be obtained and used). For each 
step, identify the individuals involved in these procedures by role (e.g., PI, Sub-I(s), investigators’ regular 
clinical staff, research institute or research center staff, etc.). If non-Sutter Health personnel or entity will 
be involved, please be sure to make that explicit in your narrative.   
 
 
Direct Mail to Employees Home 
 An IRB-approved letter will be sent from the Sutter Health mailroom to employees who work at each 
participating affiliate.   
 
The flyer and all content described below will include a description of the study, phone number, email, 
and QR code an employee can use to seek additional information about participation. 
 
Emails to Employees Using Distribution Lists 
IRB-approved content will be sent from hospital leadership approved Distribution Lists.   
 
Flyers Distributed in Affiliates 
IRB-approved flyers and screen savers will be distributed to departments including the cafeteria.   
 
Electronic Content 
IRB-approved screen savers and content will be used to submit to affiliate and Sutter Health newsletters.   

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
21
 
General Management Meetings and Town Halls 
IRB-approved content will be used to present the study in different forums throughout each affiliate. 
 
All methods of recruitment will be managed by a Clinical Research Coordinators employed by CPMCRI.  
QR code inquires will go directly to a recruitment instance of REDCap.  Employees will answer questions 
to determine if they qualify and if so, they will provide an email if they would like to consent for the study.  
Contact information will be provided at all timepoints allowing an employee to seek additional 
information from a study team member.    
 
 
D. Please describe any other recruitment methods or information you think is relevant to recruitment 
that has not been described above. If none, please put n/a: n/a 
 
IMPORTANT ►  
► All recruitment materials (e.g., newspaper advertisements, flyers, posted signs, MHO messages) must 
be submitted for IRB approval prior to use.   
► Any use or sharing of PHI for recruitment purposes without patient authorization prior to consent 
requires an IRB-approved HIPAA waiver, unless access to the PHI is limited to those who are already in a 
treatment relationship with the patient. To apply for a HIPAA waiver, please complete Section 4 of the 
Data Access Plan form. 
 
 
 
2. CONSENT 
A.  Will a signed informed consent form be obtained prior to study participation from study subjects or their 
legal representative?  
☒ Yes    
Go to next question (B) and complete rest of this section (B-F) 
☐ No      
Skip rest of Part II; go to Part III. 
 
B.   Who will be conducting the informed consent process? Please list all individuals by role (e.g., PI, Sub-I(s),  
        investigators’ regular clinical staff, research staff, etc.):  
 
Informed consent will be conducted remotely using REDCap 
 
C.   Consent Process: 
Describe the general procedures for obtaining consent, including the timing of obtaining consent (e.g., 
generally how much time will patients have to decide to participate?) and how subjects’ comprehension 
of the study will be ensured. If electronic, video, telephonic, or other remote (not in-person) methods will 
be used, please include in your description:  
 
Interested employees will seek information using multiple methods. 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
22
1.  Employees may use their personal phone and scan the QR code.  When they scan the QR code, 
they will be asked inclusion/exclusion criteria.  If they qualify using this method, they will be asked 
to provide an email address so we may send an electronic consent via REDCap.  If employees have 
any questions and concerns at any timepoint, they may contact the study team via email or phone 
number provided to seek additional information. 
2. Employees may send an email or call the study team seeking to determine if they qualify.  If so, 
the study team will email/call the employee and provide information about the study and review 
the inclusion/exclusion criteria.  Upon meeting criteria, the study team will ask if the employee 
would like to be consented and if so, the employee will provide an email and the study team will 
send a consent via REDCap.   
Prior to initiation of any study activities the completed informed consent document will be reviewed and 
verified by the study team.  REDCap consent has been set up so that participants cannot submit unless a 
signature and date and all other fields are complete. We encourage all participants to call the listed phone 
number with any questions, concerns or clarification requests. Compliance and monitoring will be 
documented in REDCap. 
 
 
D.    Do you plan to enroll non-English speaking subjects?  
 
Yes ☐      No ☒        Unknown at this time ☐     
         
 If yes:   
(i) Which languages(s) other than English do you expect?       
(ii) Please confirm you will use certified interpreters/translators and describe your plan for obtaining 
consent from these subjects (e.g., using translated versions of the IRB-approved consent form 
or short-form method?):       
 
IMPORTANT ► Full consent form should be translated into the participant’s language whenever 
possible—particularly in the context of studies that involve investigational drugs and/or devices. 
Federal regulators and SHIRB discourage routine use of the short form method and you are advised to 
limit use of this mechanism to circumstances where translating the full consent form into the subject’s 
language of fluency substantially impedes the ability to obtain a time-sensitive enrollment. For more 
information see SHIRB Guidance on Short Forms, accessible in IRBNet. Translated consents must be 
submitted to SHIRB for approval prior to use, along with the translator’s certificate. 
 
E.     Are minors eligible to be enrolled in the study at your site? Yes ☐     No ☒   
        If yes:   Please explain the consent process for this population and whether a separate assent form 
        will be used for this population:       
 
F.     Do you anticipate obtaining consent from legally authorized representatives (LAR)? Yes ☐     No ☒ 
If yes:  please explain why and what procedures will be followed to determine when a subject does 
not have capacity for consent and when the use of an LAR is appropriate:       
 
IMPORTANT ► If planning on obtaining consent from an LAR, please consult the SHIRB Guidance on 
Surrogate Consent, accessible in IRBNet. 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
23
  
 
PART III:   Waiver of Informed Consent  
 
IMPORTANT ►All studies please answer #1 below, and additional questions if applicable 
 
1. Are you requesting a waiver of informed consent for any portion of your study? Please check the 
boxes below that are applicable to your study and follow directions as indicated: 
 
 
☐  Requesting waiver of obtaining a signed informed consent form. However, participants 
will be informed about the study and convey their consent verbally or in other ways 
(sometimes called “implicit consent” - for example, by taking a survey after reading an 
information sheet).  
            Complete #2 of this Part below.  
 
☐  Requesting waiver of informed consent and participants will not be informed about 
the study. Informed consent will not be obtained, either written, verbal, or in any other 
way.  
            Complete #3 of this Part below. 
☒   Neither of the above applies. The study will be obtaining a signed informed consent 
form from all study participants. 
            Skip the rest of this section and go to [Part IV: Other Comments]. 
 
2. Request for waiver of obtaining signed informed consent form (also known as waiver of 
documentation of consent): 
 
A. By regulations, an IRB may approve a waiver of signed consent form only if ONE of the following 
scenarios applies. Please check which of these applies to your research (if neither applies to your 
research, please submit written consent form with IRB application): 
 
☐ The consent form would be the only record linking the subject to the research and the principal 
risk would be potential harm resulting from a breach of confidentiality.  
☐ The research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context.  
 
 
B. If only verbal (or other type of non-written) consent is obtained, the IRB requires an information 
sheet to be given to potential participants describing the study and key information, unless there 
are special circumstances justifying no information sheet. Will you be using an information 
sheet?  
 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
24
Yes  ☐    Please be sure to submit information sheet with your IRB application. 
No   ☐    Please explain the reason(s) justifying no information sheet:       
 
 
3.  Informed consent will not be obtained, either written, verbal, or any other way. Requesting waiver 
of informed consent. Please answer the following: 
 
By regulations, an IRB may approve a waiver of consent only it if the research could not 
practicably be carried out without the waiver. Please explain why this criterion is met (that is, 
explain why the research would NOT be feasible if you were required to get consent (either 
written or verbal) from participants:        
 
PART IV:  Other Comments 
If you have any comments about the study and/or clarifications to information submitted above that 
you would like the IRB to know about, please describe here.  
 
NOTE: If you are submitting a separate sponsor protocol, please use this space to explain any parts of the 
protocol that will NOT be implemented at your site or other pertinent deviations (for example, if the 
sponsor protocol allows for enrollment of minors but you will only be enrolling adults; or if the protocol is 
phase 1/2 but you will only be implementing the phase 2 part). 
 
 
If no other comments, please put n/a: 
This study is a collaboration with UCSF.  UCSF personnel are involved in study design, training of 
interns, and the analysis of de-identified data.   
Laura Schmidt, PhD- Laura is a co-PI of the prime grant.  She has oversite of the study and works closely 
with the team to ensure the methods and data collection are in alignment with the statistical analysis. 
Laurie Jacobs, PhD- Laurie Jacobs participates in developing the data collection plan.  She will review all 
of the de-identified data, send queries to CPMCRI team members.  She will clean and code the data and 
run statistical analyses of the entire data set. 
Elissa Epel, PhD is a co-PI of the grant.  She has oversite of the study and is the leader of the 
motivational intervention. 
 
 
 
Depression  
The study team is using the PROMIS questionnaires for depression.  Since the PROMIS depression does 
not have a question for suicidal ideation, the team would prefer to provide high scoring (severe) 
individuals with the contact number for EAP.  
 
 
 
 

 
SUTTER HEALTH 
INSTITUTIONAL REVIEW BOARD 
 
Protocol Summary Form  
  
SUTTER HEALTH IRB Protocol Summary Form.  
Version 07Oct2021 
 
25
NOTE: CVs for all investigators must be submitted in IRBNet with your application unless previously 
submitted for an already approved SHIRB study. Depending on the nature of the study, upon review the 
IRB may request additional information on the investigator's background and qualifications to perform 
study procedures.