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

NCT05972109 | Completed

• 2 other identifiers: 22-38247R01DK132870
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Abdominal; Insulin Sensitivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in Body Mass Index (BMI)

  Baseline and 12 Months

• Change in Quantity of SSB Consumption

  Baseline and 12 Months

• Change in Lipid Profile Measurements

  Baseline and 12 Months

• Change in ApoB Levels

  Baseline and 12 Months

• Change in Fasting insulin Levels

  Baseline and 12 Months

Other Outcomes (2)

• Change in Uric Acid Levels

  Baseline and 12 Months

• Change in HbA1C Levels

  Baseline and 12 Months

Study Arms (4)

Control: No workplace SSB sales ban, no brief intervention

NO INTERVENTION

Participants receive no workplace SSB sales ban (environmental intervention) and no brief counseling intervention.

Workplace SSB sales ban only

EXPERIMENTAL

Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options.

Other: Workplace SSB sales ban

Brief intervention only

EXPERIMENTAL

Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.

Behavioral: Brief Intervention

Multilevel Intervention (workplace SSB sales ban + brief intervention)

EXPERIMENTAL

Sales ban: Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options. Brief Intervention: Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.

Other: Workplace SSB sales ban; Behavioral: Brief Intervention

Interventions

Workplace SSB sales ban OTHER

Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.

Multilevel Intervention (workplace SSB sales ban + brief intervention); Workplace SSB sales ban only

Brief Intervention BEHAVIORAL

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.

Brief intervention only; Multilevel Intervention (workplace SSB sales ban + brief intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant

Sponsors & Collaborators

• Sutter Health: collaborator
• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• California Pacific Medical Center Research Institute: collaborator

Study Sites (1)

Sutter Health/California Pacific Medical Center Research Institute

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Obesity, Abdominal; Insulin Resistance

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)