University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT02585336
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.
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Interventional
Not applicable
San Francisco, California, 94143, United States
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:
Planned analyses:
For both types of analysis, we will include demographic and job-related covariates based on fit criteria to guide model selection.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 10 month minus baseline
insulin sensitivity measure derived from fasting glucose and insulin
Time frame: 10 month minus baseline
A measure of abdominal adiposity
Time frame: 2 weeks post-SSB sales ban (1-3 months after initial visit) minus baseline
outcome for intervention efficacy analysis only
Time frame: 10 month minus baseline
self-report measure of hedonic drive in eating
Time frame: 10 month minus baseline
In most analyses treated as a predictor, but used as an outcome when testing the efficacy of the intervention
Time frame: 10 month minus baseline
In most analyses treated as a predictor, but used as an outcome when testing the efficacy of the intervention
Time frame: 10 month minus baseline
Indicator of long-term glycemic control
Time frame: 10 month minus baseline
Marker of metabolic health and cardiovascular risk
University of California, San Francisco
Other
Effects of Sugar-sweetened Beverage Consumption Changes on Metabolic Health: Improving Metabolic Profile Very Effortlessly (IMPROVE)
Acronym: IMPROVE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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