Obesity PreventionNCT01990508
Randomized Trial of Financial Incentives to Reduce Sugar-sweetened Beverage Purchases by Low-income, Latino Families
A study testing Targeted beverage education and financial incentives and Traffic-light labeling of all beverages in store in people with Obesity Prevention, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Approximately 15% of the US population is enrolled in the Supplemental Nutrition Assistance Program (SNAP), and 50% are children. Although the goal is to improve nutritional health, preliminary data suggest that enrollment in SNAP is associated with obesity and metabolic risks and that SNAP reimburses $4 billion… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention
- What is being tested?
- Targeted beverage education and financial incentives and Traffic-light labeling of all beverages in store
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- purchase >75% of groceries at targeted supermarket (regular customer)
- at least one child <= 18 years old living at home
Who cannot join
- not fluent in Spanish or English
- no address or phone for contact
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Approximately 15% of the US population is enrolled in the Supplemental Nutrition Assistance Program (SNAP), and 50% are children. Although the goal is to improve nutritional health, preliminary data suggest that enrollment in SNAP is associated with obesity and metabolic risks and that SNAP reimburses $4 billion annually for sugar-sweetened beverages (SSBs). This pilot project tests an innovative strategy to reduce purchase of non-nutritive, SSBs by low-income families with children by combining targeted point-of-purchase education with a randomized trial of financial incentives to discourage purchase of unhealthy beverages. The study will take place at a mid-size grocery store that is located in a low-income, Latino community and where 30% of purchases are made with SNAP. Targeted beverage education will be provided to all study subjects with a traffic-light system to identify healthy and unhealthy beverages at the point-of-purchase. Individual beverage purchases will be tracked by electronically stored cash register sales. Supplementary validation of beverage consumption will be assessed by 24 hour dietary recall. Aim 1 is to conduct a randomized controlled trial to compare purchase and consumption of SSBs by families assigned to a financial incentive to reduce purchase of SSBs with families assigned to control (no incentives). Aim 2 is to compare the purchase of SSBs by families in both arms during the study period when they are exposed to the traffic-light system to a baseline period prior to traffic-light education. Results of this project will provide pilot data for larger scale interventions to promote healthy choices among low-income families.
- Conditions
- Obesity Prevention
- Being tested
- Targeted beverage education and financial incentives, Traffic-light labeling of all beverages in store
- Keywords
- sugar-sweetened beverages, traffic-light labels, financial incentives, low-income community, obesity prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted beverage education and financial incentivesBehavioural
Traffic-light labeling of all beverages in storeBehavioural
All beverages in the supermarket will be labeled as red, yellow, or green
| Study group | Role | What they receive |
|---|---|---|
| Targeted beverage education and financial incentives | Experimental | Study subjects receive monthly letters with beverage education and financial incentives for not purchasing sugar-sweetened beverages Receives: Behavioral: Targeted beverage education and financial incentives; Behavioral: Traffic-light labeling of all beverages in store |
| Control | Sham comparator | Monthly letters with generic nutrition information only Receives: Behavioral: Traffic-light labeling of all beverages in store |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purchase of sugar-sweetened beverages
Measured: 4 months
Secondary outcomes (1)
Consumption of sugar-sweetened beverages
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
- Investigators
- Anne N Thorndike, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990508
- Sponsor's protocol ID
- 2013P001130
- Status last verified
- Oct 2015
- First submitted
- 15 Nov 2013
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Franckle RL, Levy DE, Macias-Navarro L, Rimm EB, Thorndike AN. Traffic-light labels and financial incentives to reduce sugar-sweetened beverage purchases by low-income Latino families: a randomized controlled trial. Public Health Nutr. 2018 Jun;21(8):1426-1434. doi: 10.1017/S1368980018000319. Epub 2018 Mar 1.
PubMed 29493476
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Financial Incentives to Reduce Sugar-sweetened Beverage Purchases by Low-income, Latino Families
- ClinicalTrials.gov ID
- NCT01990508
- Acronym / sponsor ID
- 2013P001130
- Conditions
- Obesity Prevention
- Keywords
- sugar-sweetened beverages, traffic-light labels, financial incentives, low-income community, obesity prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Nov 2013 (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.
Approximately 15% of the US population is enrolled in the Supplemental Nutrition Assistance Program (SNAP), and 50% are children. Although the goal is to improve nutritional health, preliminary data suggest that enrollment in SNAP is associated with obesity and metabolic risks and that SNAP reimburses $4 billion annually for sugar-sweetened beverages (SSBs). This pilot project tests an innovative strategy to reduce purchase of non-nutritive, SSBs by low-income families with children by combining targeted point-of-purchase education with a randomized trial of financial incentives to discourage purchase of unhealthy beverages. The study will take place at a mid-size grocery store that is located in a low-income, Latino community and where 30% of purchases are made with SNAP. Targeted beverage education will be provided to all study subjects with a traffic-light system to identify healthy and unhealthy beverages at the point-of-purchase. Individual beverage purchases will be tracked by electronically stored cash register sales. Supplementary validation of beverage consumption will be assessed by 24 hour dietary recall. Aim 1 is to conduct a randomized controlled trial to compare purchase and consumption of SSBs by families assigned to a financial incentive to reduce purchase of SSBs with families assigned to control (no incentives). Aim 2 is to compare the purchase of SSBs by families in both arms during the study period when they are exposed to the traffic-light system to a baseline period prior to traffic-light education. Results of this project will provide pilot data for larger scale interventions to promote healthy choices among low-income families.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted beverage education and financial incentives | Experimental | Behavioral: Targeted beverage education and financial incentives, Behavioral: Traffic-light labeling of all beverages in storeStudy subjects receive monthly letters with beverage education and financial incentives for not purchasing sugar-sweetened beverages |
| Control | Sham comparator | Behavioral: Traffic-light labeling of all beverages in storeMonthly letters with generic nutrition information only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- purchase >75% of groceries at targeted supermarket (regular customer)
- at least one child <= 18 years old living at home
Key exclusion criteria (2 listed)
- not fluent in Spanish or English
- no address or phone for contact
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 |
|---|---|---|
| Targeted beverage education and financial incentives | Behavioural | Targeted beverage education and financial incentives |
| Traffic-light labeling of all beverages in storeAll beverages in the supermarket will be labeled as red, yellow, or green | Behavioural | Control, Targeted beverage education and financial incentives |
Primary outcome
Purchase of sugar-sweetened beverages
Time frame: 4 months
1 secondary outcome
Consumption of sugar-sweetened beverages
Time frame: 4 months
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 6 Oct 2015.
- Derived from this study: PubMed 29493476Franckle RL, Levy DE, Macias-Navarro L, Rimm EB, Thorndike AN. Traffic-light labels and financial incentives to reduce sugar-sweetened beverage purchases by low-income Latino families: a randomized controlled trial. Public Health Nutr. 2018 Jun;21(8):1426-1434. doi: 10.1017/S1368980018000319. Epub 2018 Mar 1.
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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.
Anne N Thorndike, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted beverage education and financial incentives and Traffic-light labeling of all beverages in store in people with Obesity Prevention, run by Massachusetts General Hospital 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 2 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 6 Oct 2015. 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. Some participants in this study may receive a placebo. 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?
Purchase of sugar-sweetened beverages (time frame: 4 months). 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 NCT01990508, which also lists 1 linked publication.
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 6 Oct 2015.