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

Not Applicable

Completed

• Conditions: Metabolic Health
• Interventions: Behavioral: Brief intervention

• Registration Number: NCT02585336
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

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 Timeline

• Study Start: 2015-07-28
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2016-10-16
• Study Completion: 2016-10-16
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief intervention	Brief intervention	-

Primary Outcome Measures

Name	Time	Method
Homeostatic Model Assessment ratio (HOMA)	10 month minus baseline	insulin sensitivity measure derived from fasting glucose and insulin

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States