Changes in Sugar-sweetened Beverage Intake and Metabolic Health: Improving Metabolic Profile Very Effortlessly
IMPROVE
Effects of Sugar-sweetened Beverage Consumption Changes on Metabolic Health: Improving Metabolic Profile Very Effortlessly (IMPROVE)
1 other identifier
interventional
214
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2016
CompletedJanuary 25, 2021
January 1, 2021
1.2 years
October 21, 2015
January 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Homeostatic Model Assessment ratio (HOMA)
insulin sensitivity measure derived from fasting glucose and insulin
10 month minus baseline
Secondary Outcomes (2)
Waist-hip circumference ratio
10 month minus baseline
Consumption of sugar-sweetened beverages
2 weeks post-SSB sales ban (1-3 months after initial visit) minus baseline
Other Outcomes (5)
Reward-based eating drive
10 month minus baseline
Consumption of sugar-sweetened beverages
10 month minus baseline
Total dietary sugar consumption
10 month minus baseline
- +2 more other outcomes
Study Arms (2)
Observation
NO INTERVENTIONBrief intervention
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Employed at UCSF
- Reports drinking an average of 60oz or more of sugar-sweetened beverages per week (approximately 8oz/day), over the past month.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
Related Publications (3)
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.
PMID: 31657840RESULTWojcicki 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.
PMID: 34235373DERIVEDMason 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.
PMID: 33778854DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elissa Epel, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 23, 2015
Study Start
July 28, 2015
Primary Completion
October 16, 2016
Study Completion
October 16, 2016
Last Updated
January 25, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 5 years
- Access Criteria
- Deidentified participant data open to all researchers.
Share database on open science framework.