Metabolic HealthIMPROVENCT02585336
Changes in Sugar-sweetened Beverage Intake and Metabolic Health: Improving Metabolic Profile Very Effortlessly
A study testing Brief intervention in people with Metabolic Health, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Metabolic Health
- What is being tested?
- Brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2015to 16 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Employed at UCSF
- Reports drinking an average of 60oz or more of sugar-sweetened beverages per week (approximately 8oz/day), over the past month.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Effects of Sugar-sweetened Beverage Consumption Changes on Metabolic Health: Improving Metabolic Profile Very Effortlessly (IMPROVE)
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.
Read the 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:
- 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.
- Conditions
- Metabolic Health
- Being tested
- Brief intervention
- Keywords
- Sugar-Sweetened beverages, Metabolic health, Soft drinks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Not described |
| Brief intervention | Experimental | Not described Receives: Behavioral: Brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostatic Model Assessment ratio (HOMA)
insulin sensitivity measure derived from fasting glucose and insulin
Measured: 10 month minus baseline
Secondary outcomes (2)
Waist-hip circumference ratio
A measure of abdominal adiposity
Measured: 10 month minus baseline
Consumption of sugar-sweetened beverages
outcome for intervention efficacy analysis only
Measured: 2 weeks post-SSB sales ban (1-3 months after initial visit) minus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start28 Jul 2015
- Primary completion16 Oct 2016
- Study completion16 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic HealthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elissa Epel, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585336
- Sponsor's protocol ID
- 15-16880
- Acronym
- IMPROVE
- Status last verified
- Jan 2021
- First submitted
- 21 Oct 2015
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Share database on open science framework.
Publications
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.
PubMed 31657840Wojcicki 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.
PubMed 34235373Mason 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.
PubMed 33778854
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sugar-sweetened Beverage Consumption Changes on Metabolic Health: Improving Metabolic Profile Very Effortlessly (IMPROVE)
- ClinicalTrials.gov ID
- NCT02585336
- Acronym / sponsor ID
- IMPROVE / 15-16880
- Conditions
- Metabolic Health
- Keywords
- Sugar-Sweetened beverages, Metabolic health, Soft drinks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- 16 Oct 2016 (actual)
- Study completion
- 16 Oct 2016 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | – |
| Brief intervention | Experimental | Behavioral: Brief intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Employed at UCSF
- Reports drinking an average of 60oz or more of sugar-sweetened beverages per week (approximately 8oz/day), over the past month.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief interventionAn 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. | Behavioural | Brief intervention |
Primary outcome
Homeostatic Model Assessment ratio (HOMA)
Time frame: 10 month minus baseline
insulin sensitivity measure derived from fasting glucose and insulin
2 secondary outcomes
Waist-hip circumference ratio
Time frame: 10 month minus baseline
Consumption of sugar-sweetened beverages
Time frame: 2 weeks post-SSB sales ban (1-3 months after initial visit) minus baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Results publication: PubMed 31657840Epel 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.
- Derived from this study: PubMed 34235373Wojcicki 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.
- Derived from this study: PubMed 33778854Mason 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.
- Individual participant dataSharing planned: Yes. Share database on open science framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elissa Epel, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief intervention in people with Metabolic Health, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostatic Model Assessment ratio (HOMA) (time frame: 10 month minus baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585336, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.