Clinical trial NCT05972109: Metabolic Health Improvement Program: Effects of a Workplace Sugary Beverages Sales Ban and Motivational Counseling
Official title: Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational Counseling Intervention on Adiposity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Abdominal
Insulin Sensitivity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Sutter Health
name: California Pacific Medical Center Research Institute
First posted: 2023-08-02
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Abdominal Adiposity (Waist Circumference)
timeFrame: Baseline and 12 Months
measure: Change in Insulin Sensitivity (HOMA)
timeFrame: Baseline and 12 Months
Secondary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 12 Months
measure: Change in Quantity of SSB Consumption
timeFrame: Baseline and 12 Months
measure: Change in Lipid Profile Measurements
timeFrame: Baseline and 12 Months
measure: Change in ApoB Levels
timeFrame: Baseline and 12 Months
measure: Change in Fasting insulin Levels
timeFrame: Baseline and 12 Months
measure: Change in Fasting Glucose Levels
timeFrame: Baseline and 12 Months
Other outcomes:
measure: Change in Uric Acid Levels
timeFrame: Baseline and 12 Months
measure: Change in HbA1C Levels
timeFrame: Baseline and 12 Months
Locations:
city: San Francisco
country: United States
facility: Sutter Health/California Pacific Medical Center Research Institute
state: California
Study officials:
affiliation: University of California, San Francisco
name: Laura A Schmidt, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Elissa Epel, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sutter Health/California Pacific Medical Center Research Institute
name: Jamey Schmidt
role: PRINCIPAL_INVESTIGATOR
References: