Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02585336 |
| Other study ID # |
15-16880 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 28, 2015 |
| Est. completion date |
October 16, 2016 |
Study information
| Verified date |
January 2021 |
| Source |
University of California, San Francisco |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
