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Completed

NCT Number: NCT02585336

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

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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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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:

  • 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.
  • 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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief intervention

Behavioral

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.

Primary outcomes

  1. Homeostatic Model Assessment ratio (HOMA)

    Time frame: 10 month minus baseline

    insulin sensitivity measure derived from fasting glucose and insulin

Secondary outcomes

  1. Waist-hip circumference ratio

    Time frame: 10 month minus baseline

    A measure of abdominal adiposity

  2. Consumption of sugar-sweetened beverages

    Time frame: 2 weeks post-SSB sales ban (1-3 months after initial visit) minus baseline

    outcome for intervention efficacy analysis only

Other outcomes

  1. Reward-based eating drive

    Time frame: 10 month minus baseline

    self-report measure of hedonic drive in eating

  2. Consumption of sugar-sweetened beverages

    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

  3. Total dietary sugar consumption

    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

  4. Glycated hemoglobin (HbA1c)

    Time frame: 10 month minus baseline

    Indicator of long-term glycemic control

  5. Fasting triglycerides

    Time frame: 10 month minus baseline

    Marker of metabolic health and cardiovascular risk

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: IMPROVE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2015
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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