Metabolic Health Improvement Program: Effects of a Workplace Sugary Beverages Sales Ban and Motivational Counseling

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational Counseling Intervention on Adiposity

Conditions
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Obesity, Abdominal, Insulin Sensitivity

Intervention / Treatment
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* Other: Workplace SSB sales ban
* Behavioral: Brief Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control: No workplace SSB sales ban, no brief intervention<br>Participants receive no workplace SSB sales ban (environmental intervention) and no brief counseling intervention. | |
| Experimental: Workplace SSB sales ban only<br>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. | Other: Workplace SSB sales ban<br>* Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.<br>|
| Experimental: Brief intervention only<br>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. | Behavioral: Brief Intervention<br>* 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.<br>|
| Experimental: Multilevel Intervention (workplace SSB sales ban + brief intervention)<br>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. | Other: Workplace SSB sales ban<br>* Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.<br>Behavioral: Brief Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline and 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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. | 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. | 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. | Baseline and 12 Months |