Changes in Sugar-sweetened Beverage Intake and Metabolic Health: Improving Metabolic Profile Very Effortlessly (IMPROVE)

Effects of Sugar-sweetened Beverage Consumption Changes on Metabolic Health: Improving Metabolic Profile Very Effortlessly (IMPROVE)

Sugar-sweetened beverages (SSBs) have been epidemiologically linked to serious health problems including heart disease, liver disease, and diabetes. This study will recruit frequent SSB drinkers who are employees at the University of California, San Francisco (UCSF) and measure markers of metabolic health on two occasions, 10 months apart. During this time, UCSF will cease selling SSBs at all campus and medical center locations. Additionally, at the first assessment half of participants will be randomly assigned to a brief intervention to help reduce SSB consumption, consisting of a 10-20 minute semi-structured interview designed to share health information about SSBs, elicit motivations to reduce consumption, and help set concrete plans to reduce consumption. The investigators will be able to compare changes in metabolic health among those who do and do not reduce SSB consumption. This will make a unique contribution to the growing evidence regarding both the effects of SSB consumption on health and the modifiability of SSB-related health conditions.

Study Overview

• Status: Completed
• Conditions: Metabolic Health
• Intervention / Treatment: Behavioral: Brief intervention

Detailed Description

Sugar-sweetened beverages (SSBs) have been epidemiologically linked to serious health problems including heart disease, liver disease, and diabetes. This study will recruit frequent SSB drinkers who are employees at the University of California, San Francisco (UCSF) and measure markers of metabolic health on two occasions, 10 months apart. During this time, UCSF will cease selling SSBs at all campus and medical center locations. Additionally, at the first assessment half of participants will be randomly assigned to a brief intervention to help reduce SSB consumption, consisting of a 10-20 minute semi-structured interview designed to share health information about SSBs, elicit motivations to reduce consumption, and help set concrete plans to reduce consumption. We will be able to compare changes in metabolic health among those who do and do not reduce SSB consumption. This will make a unique contribution to the growing evidence regarding both the effects of SSB consumption on health and the modifiability of SSB-related health conditions.

Two key clarifications about the design of this study:

1. The cessation of sugar-sweetened beverage sales is a pre-existing workplace initiative. This study is taking advantage of its initiation but it is not part of the study intervention.
2. The primary predictor in this study is SSB consumption, not condition assignment. Although we will report on the efficacy of the brief intervention, the main goal of the study is to examine the correlational relationship between changes in SSB consumption and changes in health, whether the reduction is associated with the intervention or with other factors.

Planned analyses:

1. For all outcomes other than sugar consumption and SSB consumption (see below), the primary analytic strategy will be to correlate changes in SSB consumption with changes in the outcome.
2. We will additionally assess the efficacy of the university initiative and the brief counseling intervention using a linear mixed regression model estimating the effects of 1) time (pre to post), representing the effect of the university SSB initiative, and 2) assignment to the brief intervention interacting with time.

For both types of analysis, we will include demographic and job-related covariates based on fit criteria to guide model selection.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Employed at UCSF
• Reports drinking an average of 60oz or more of sugar-sweetened beverages per week (approximately 8oz/day), over the past month.

Exclusion Criteria:

• Unwilling or medically advised not to fast in preparation for a fasting blood draw
• Reports vasovagal response (fainting) following blood draws or needle sticks in the past.
• Pregnant (health outcome measures from pre- to post-partum will not be comparable).
• Diagnosed with diabetes (type 1 or type 2)
• Not fluent in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observation
Experimental: Brief intervention	Behavioral: Brief intervention; An interviewer provides health information, elicits motivation to reduce SSB consumption, and helps participants make implementation plans. Booster phone calls occur at 1 week after the intervention visit, and at 2 weeks and 24 weeks following the date on which SSBs sales ended at the participant's work location.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homeostatic Model Assessment ratio (HOMA)	insulin sensitivity measure derived from fasting glucose and insulin	10 month minus baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist-hip circumference ratio	A measure of abdominal adiposity	10 month minus baseline
Consumption of sugar-sweetened beverages	outcome for intervention efficacy analysis only	2 weeks post-SSB sales ban (1-3 months after initial visit) minus baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reward-based eating drive	self-report measure of hedonic drive in eating	10 month minus baseline
Consumption of sugar-sweetened beverages	In most analyses treated as a predictor, but used as an outcome when testing the efficacy of the intervention	10 month minus baseline
Total dietary sugar consumption	In most analyses treated as a predictor, but used as an outcome when testing the efficacy of the intervention	10 month minus baseline
Glycated hemoglobin (HbA1c)	Indicator of long-term glycemic control	10 month minus baseline
Fasting triglycerides	Marker of metabolic health and cardiovascular risk	10 month minus baseline

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Publications and helpful links

General Publications

• Epel ES, Hartman A, Jacobs LM, Leung C, Cohn MA, Jensen L, Ishkanian L, Wojcicki J, Mason AE, Lustig RH, Stanhope KL, Schmidt LA. Association of a Workplace Sales Ban on Sugar-Sweetened Beverages With Employee Consumption of Sugar-Sweetened Beverages and Health. JAMA Intern Med. 2020 Jan 1;180(1):9-16. doi: 10.1001/jamainternmed.2019.4434.
• Wojcicki JM, Lustig RH, Jacobs LM, Mason AE, Hartman A, Leung C, Stanhope K, Lin J, Schmidt LA, Epel ES. Longer Leukocyte Telomere Length Predicts Stronger Response to a Workplace Sugar-Sweetened Beverage Sales Ban: An Exploratory Study. Curr Dev Nutr. 2021 May 26;5(7):nzab084. doi: 10.1093/cdn/nzab084. eCollection 2021 Jul.
• Mason AE, Schmidt L, Ishkanian L, Jacobs LM, Leung C, Jensen L, Cohn MA, Schleicher S, Hartman AR, Wojcicki JM, Lustig RH, Epel ES. A Brief Motivational Intervention Differentially Reduces Sugar-sweetened Beverage (SSB) Consumption. Ann Behav Med. 2021 Oct 27;55(11):1116-1129. doi: 10.1093/abm/kaaa123.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2015
• Primary Completion (Actual): October 16, 2016
• Study Completion (Actual): October 16, 2016

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Metabolic health; Sugar-Sweetened beverages; Soft drinks
• Other Study ID Numbers: 15-16880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share database on open science framework.
• IPD Sharing Time Frame: 5 years
• IPD Sharing Access Criteria: Deidentified participant data open to all researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF