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

NCT ID: NCT05972109

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2026-10-01

Brief Summary

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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

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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.

Conditions

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Obesity, Abdominal Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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Control: No workplace SSB sales ban, no brief intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Workplace SSB sales ban

Intervention Type OTHER

Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.

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.

Group Type EXPERIMENTAL

Brief Intervention

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Workplace SSB sales ban

Intervention Type OTHER

Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.

Brief Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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Workplace SSB sales ban

Environmental Intervention. The hospital food services will replace sugary drinks with non-sugar added alternative beverages throughout the campus.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Sutter Health

OTHER

Sponsor Role collaborator

California Pacific Medical Center Research Institute

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura A Schmidt, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Elissa Epel, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Jamey Schmidt

Role: PRINCIPAL_INVESTIGATOR

Sutter Health/California Pacific Medical Center Research Institute

Locations

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Sutter Health/California Pacific Medical Center Research Institute

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01DK132870

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-38247

Identifier Type: -

Identifier Source: org_study_id