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

Not Applicable

Recruiting

• Conditions: Obesity, Abdominal; Insulin Sensitivity
• Interventions: Behavioral: Brief Intervention; Other: Workplace SSB sales ban

• Registration Number: NCT05972109
• Lead Sponsor: University of California, San Francisco

Brief 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.

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 Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-07-25
• Study Start: 2023-08-01
• Study First Posted: 2023-08-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Brief intervention only	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.
Workplace SSB sales ban only	Workplace SSB 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.
Multilevel Intervention (workplace SSB sales ban + brief intervention)	Workplace SSB sales ban	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.
Multilevel Intervention (workplace SSB sales ban + brief intervention)	Brief Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Insulin Sensitivity (HOMA)	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.
Change in Abdominal Adiposity (Waist Circumference)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Lipid Profile Measurements	Baseline and 12 Months	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).
Change in Fasting Glucose Levels	Baseline and 12 Months	Fasting blood level of glucose. The study will measure the change between baseline and 12 month Fasting Glucose blood levels.
Change in Quantity of SSB Consumption	Baseline and 12 Months	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.
Change in Body Mass Index (BMI)	Baseline and 12 Months	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.
Change in ApoB Levels	Baseline and 12 Months	Blood level of ApoB. The study will measure the change between baseline and 12 month ApoB blood levels.
Change in Fasting insulin Levels	Baseline and 12 Months	Fasting blood level of insulin. The study will measure the change between baseline and 12 month Fasting insulin blood levels.

Trial Locations

Locations (1)

Sutter Health/California Pacific Medical Center Research Institute; 🇺🇸 San Francisco, California, United States