Clinical trial NCT02585336: Changes in Sugar-sweetened Beverage Intake and Metabolic Health: Improving Metabolic Profile Very Effortlessly
Official title: Effects of Sugar-sweetened Beverage Consumption Changes on Metabolic Health: Improving Metabolic Profile Very Effortlessly (IMPROVE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Health
Keywords: Sugar-Sweetened beverages
Metabolic health
Soft drinks
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 214
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Homeostatic Model Assessment ratio (HOMA)
timeFrame: 10 month minus baseline
Secondary outcomes:
measure: Waist-hip circumference ratio
timeFrame: 10 month minus baseline
measure: Consumption of sugar-sweetened beverages
timeFrame: 2 weeks post-SSB sales ban (1-3 months after initial visit) minus baseline
Other outcomes:
measure: Reward-based eating drive
timeFrame: 10 month minus baseline
measure: Consumption of sugar-sweetened beverages
timeFrame: 10 month minus baseline
measure: Total dietary sugar consumption
timeFrame: 10 month minus baseline
measure: Glycated hemoglobin (HbA1c)
timeFrame: 10 month minus baseline
measure: Fasting triglycerides
timeFrame: 10 month minus baseline
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elissa Epel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.