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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02585336
Acronym
IMPROVE
Enrollment
214
Registered
2015-10-23
Start date
2015-07-28
Completion date
2016-10-16
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Health

Keywords

Sugar-Sweetened beverages, Metabolic health, Soft drinks

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.

Interventions

BEHAVIORALBrief 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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Homeostatic Model Assessment ratio (HOMA)10 month minus baselineinsulin sensitivity measure derived from fasting glucose and insulin

Secondary

MeasureTime frameDescription
Waist-hip circumference ratio10 month minus baselineA measure of abdominal adiposity
Consumption of sugar-sweetened beverages2 weeks post-SSB sales ban (1-3 months after initial visit) minus baselineoutcome for intervention efficacy analysis only

Other

MeasureTime frameDescription
Glycated hemoglobin (HbA1c)10 month minus baselineIndicator of long-term glycemic control
Reward-based eating drive10 month minus baselineself-report measure of hedonic drive in eating
Fasting triglycerides10 month minus baselineMarker of metabolic health and cardiovascular risk
Consumption of sugar-sweetened beverages10 month minus baselineIn most analyses treated as a predictor, but used as an outcome when testing the efficacy of the intervention
Total dietary sugar consumption10 month minus baselineIn most analyses treated as a predictor, but used as an outcome when testing the efficacy of the intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026