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

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05972109

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Sutter Health (Other), California Pacific Medical Center Research Institute (Other)

700

Enrollment

Location

Arms

Anticipated Duration (Months)

26.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Abdominal Insulin Sensitivity	Other: Workplace SSB sales ban Behavioral: Brief Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention 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.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)

Masking Description:

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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 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 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 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.
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.

Other Outcome Measures

Change in Uric Acid Levels [Baseline and 12 Months]
Blood level of Uric Acid. The study will measure the change between baseline and 12 month Uric Acid blood levels.
Change in HbA1C Levels [Baseline and 12 Months]
Blood Level of HbA1C. The study will measure the change between baseline and 12 month HbA1C blood levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sutter Health/California Pacific Medical Center Research Institute	San Francisco	California	United States	94115

Sponsors and Collaborators

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

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 Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT05972109

Other Study ID Numbers:

22-38247
R01DK132870

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Insulin Resistance

Obesity, Abdominal

Study Results

No Results Posted as of Aug 2, 2023