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

Primary Purpose

Obesity, Abdominal, Insulin Sensitivity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Workplace SSB sales ban
Brief Intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Abdominal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sutter Health/California Pacific Medical Center Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control: No workplace SSB sales ban, no brief intervention

Workplace SSB sales ban only

Brief intervention only

Multilevel Intervention (workplace SSB sales ban + brief intervention)

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).
Change in ApoB Levels
Blood level of ApoB. The study will measure the change between baseline and 12 month ApoB blood levels.
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.
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.

Full Information

First Posted
July 25, 2023
Last Updated
July 25, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sutter Health, California Pacific Medical Center Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05972109
Brief Title
Metabolic Health Improvement Program: Effects of a Workplace Sugary Beverages Sales Ban and Motivational Counseling
Acronym
MHIP
Official Title
Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational Counseling Intervention on Adiposity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sutter Health, California Pacific Medical Center Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal, Insulin Sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
None (Open Label)
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.
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control: No workplace SSB sales ban, no brief intervention
Arm Type
No Intervention
Arm Description
Participants receive no workplace SSB sales ban (environmental intervention) and no brief counseling intervention.
Arm Title
Workplace SSB sales ban only
Arm Type
Experimental
Arm Description
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.
Arm Title
Brief intervention only
Arm Type
Experimental
Arm Description
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.
Arm Title
Multilevel Intervention (workplace SSB sales ban + brief intervention)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Workplace SSB sales ban
Intervention Description
Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Abdominal Adiposity (Waist Circumference)
Description
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.
Time Frame
Baseline and 12 Months
Title
Change in Insulin Sensitivity (HOMA)
Description
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.
Time Frame
Baseline and 12 Months
Secondary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
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.
Time Frame
Baseline and 12 Months
Title
Change in Quantity of SSB Consumption
Description
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.
Time Frame
Baseline and 12 Months
Title
Change in Lipid Profile Measurements
Description
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).
Time Frame
Baseline and 12 Months
Title
Change in ApoB Levels
Description
Blood level of ApoB. The study will measure the change between baseline and 12 month ApoB blood levels.
Time Frame
Baseline and 12 Months
Title
Change in Fasting insulin Levels
Description
Fasting blood level of insulin. The study will measure the change between baseline and 12 month Fasting insulin blood levels.
Time Frame
Baseline and 12 Months
Title
Change in Fasting Glucose Levels
Description
Fasting blood level of glucose. The study will measure the change between baseline and 12 month Fasting Glucose blood levels.
Time Frame
Baseline and 12 Months
Other Pre-specified Outcome Measures:
Title
Change in Uric Acid Levels
Description
Blood level of Uric Acid. The study will measure the change between baseline and 12 month Uric Acid blood levels.
Time Frame
Baseline and 12 Months
Title
Change in HbA1C Levels
Description
Blood Level of HbA1C. The study will measure the change between baseline and 12 month HbA1C blood levels.
Time Frame
Baseline and 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sweet Study Contact
Phone
415-600-5848
Email
sweet@sutterhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Schmidt, Ph.D
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elissa Epel, Ph.D
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamey Schmidt
Organizational Affiliation
Sutter Health/California Pacific Medical Center Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sutter Health/California Pacific Medical Center Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamey M Schmidt, RD
Phone
415-600-1182
Email
jamey.schmidt@sutterhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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