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

Insulin Sensitivity Clinical Trial

— MHIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972109
• Other study ID #: 22-38247
• Secondary ID: R01DK132870
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: Sweet Study Contact
• Phone: 415-600-5848
• Email: sweet[@]sutterhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Obesity, Abdominal

Intervention

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.

Locations

Country	Name	City	State
United States	Sutter Health/California Pacific Medical Center Research Institute	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	California Pacific Medical Center Research Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sutter Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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