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Behavioral Intervention

Sugary Drink Ban + Counseling for Metabolic Health Improvement (MHIP Trial)

N/A

Recruiting

Led By Laura A Schmidt, Ph.D

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if banning sugary drinks in hospitals and counselling employees can improve their health.

Who is the study for?

This trial is for full-time employees at certain Sutter Health sites who drink three or more sugary drinks a week, can speak and read English, and are willing to have two fasting blood tests. Pregnant individuals cannot participate.

What is being tested?

The study examines the effects of not selling sugary drinks (SSBs) at work and giving motivational counseling on employee health, specifically focusing on insulin resistance and abdominal obesity.

What are the potential side effects?

There may be minimal side effects from participating in this trial as it involves lifestyle changes rather than medication. However, some participants might experience cravings or withdrawal symptoms from reducing sugar intake.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Abdominal Adiposity (Waist Circumference)

Change in Insulin Sensitivity (HOMA)

Secondary study objectives

Change in ApoB Levels

Change in Body Mass Index (BMI)

Change in Fasting Glucose Levels

+3 more

Other study objectives

Change in HbA1C Levels

Change in Uric Acid Levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Workplace SSB sales ban onlyExperimental Treatment1 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.

Group II: Multilevel Intervention (workplace SSB sales ban + brief intervention)Experimental Treatment2 Interventions

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 III: Brief intervention onlyExperimental Treatment1 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 IV: Control: No workplace SSB sales ban, no brief interventionActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brief Intervention

2008

Completed Phase 3

~5860

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