Insulin Sensitivity, Obesity, Abdominal
Conditions
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.
Interventions
OTHERWorkplace SSB sales ban
Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.
BEHAVIORALBrief 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.
Sponsors
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sutter Health
California Pacific Medical Center Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Masking 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura A Schmidt, Ph.D
University of California, San Francisco
PRINCIPAL_INVESTIGATORElissa Epel, Ph.D
University of California, San Francisco
PRINCIPAL_INVESTIGATORJamey Schmidt
Sutter Health/California Pacific Medical Center Research Institute
Outcome results
None listed