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

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.

Study Overview

• Status: Recruiting
• Conditions: Insulin Sensitivity; Obesity, Abdominal
• Intervention / Treatment: Other: Workplace SSB sales ban; Behavioral: Brief Intervention

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 Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sweet Study Contact; Phone Number: 415-600-5848; Email: sweet@sutterhealth.org

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Recruiting
      • Sutter Health/California Pacific Medical Center Research Institute
      • Contact: Jamey M Schmidt, RD; Phone Number: 415-600-1182; Email: jamey.schmidt@sutterhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Uric Acid Levels	Blood level of Uric Acid. The study will measure the change between baseline and 12 month Uric Acid blood levels.	Baseline and 12 Months
Change in HbA1C Levels	Blood Level of HbA1C. The study will measure the change between baseline and 12 month HbA1C blood levels.	Baseline and 12 Months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); California Pacific Medical Center Research Institute; Sutter Health
• Investigators: Principal Investigator: Laura A Schmidt, Ph.D, University of California, San Francisco; Principal Investigator: Elissa Epel, Ph.D, University of California, San Francisco; Principal Investigator: Jamey Schmidt, Sutter Health/California Pacific Medical Center Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Obesity; Insulin Resistance; Obesity, Abdominal
• Other Study ID Numbers: 22-38247; R01DK132870 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No