Food LabelingNCT01604499
Building on a Point-of-purchase Intervention to Encourage Healthy Food Choices
A study testing Feedback letters and Feedback plus incentives in people with Food Labeling, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study builds on the framework of a previously implemented color-coded food labeling intervention in a hospital cafeteria by testing the incremental effectiveness of providing employees with individual feedback and incentives for increasing healthy purchases in a 3-arm randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Labeling
- What is being tested?
- Feedback letters and Feedback plus incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,672 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2013
- 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
- Employee at Massachusetts General Hospital who uses a cafeteria debit card to pay for cafeteria purchases
Who cannot join
- Employees who do not have a cafeteria debit card
- Employees with cafeteria debit card but who use it fewer than 3 times a month for the 3 months prior to start of trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study builds on the framework of a previously implemented color-coded food labeling intervention in a hospital cafeteria by testing the incremental effectiveness of providing employees with individual feedback and incentives for increasing healthy purchases in a 3-arm randomized controlled trial. The investigators hypothesize that employees assigned to receive feedback will increase healthy purchases more than employees who receive no contact and that employees who receive feedback plus incentives will increase healthy purchases more than those who receive feedback alone.
- Conditions
- Food Labeling
- Being tested
- Feedback letters, Feedback plus incentives
- Keywords
- Healthy eating, Incentives, Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback lettersBehavioural
Subjects receive feedback letters about the proportion of green, yellow, and red purchases in the cafeteria per month with comparisons to "all employees" and to the "healthiest employees eaters"
Feedback plus incentivesBehavioural
Subjects receive feedback letters plus small incentives to increase healthy (green-labeled) purchases in the next month
| Study group | Role | What they receive |
|---|---|---|
| Feedback only | Experimental | Subjects receive feedback letters about the proportion of green, yellow, and red purchases in the cafeteria per month with comparisons to "all employees" and to the "healthiest employees eaters" Receives: Behavioral: Feedback letters |
| Feedback plus incentives | Experimental | Subjects receive feedback letters plus small incentives to increase healthy (green-labeled) purchases in the next month Receives: Behavioral: Feedback plus incentives |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employee purchases of healthy (green-labeled) items
Measured: 6 months
Secondary outcomes (1)
Employee purchases of unhealthy (red-labeled) items
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionMay 2013
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 Food LabelingStudies 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
- 2,672 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- 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
- NCT01604499
- Sponsor's protocol ID
- 2011D004784
- Status last verified
- Oct 2015
- First submitted
- 21 May 2012
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Thorndike AN, Riis J, Levy DE. Social norms and financial incentives to promote employees' healthy food choices: A randomized controlled trial. Prev Med. 2016 May;86:12-8. doi: 10.1016/j.ypmed.2016.01.017. Epub 2016 Jan 29.
PubMed 26827617
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
- Building on a Point-of-purchase Intervention to Encourage Healthy Food Choices
- ClinicalTrials.gov ID
- NCT01604499
- Acronym / sponsor ID
- 2011D004784
- Conditions
- Food Labeling
- Keywords
- Healthy eating, Incentives, Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,672 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 May 2012 (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.
This study builds on the framework of a previously implemented color-coded food labeling intervention in a hospital cafeteria by testing the incremental effectiveness of providing employees with individual feedback and incentives for increasing healthy purchases in a 3-arm randomized controlled trial. The investigators hypothesize that employees assigned to receive feedback will increase healthy purchases more than employees who receive no contact and that employees who receive feedback plus incentives will increase healthy purchases more than those who receive feedback alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feedback only | Experimental | Behavioral: Feedback lettersSubjects receive feedback letters about the proportion of green, yellow, and red purchases in the cafeteria per month with comparisons to "all employees" and to the "healthiest employees eaters" |
| Feedback plus incentives | Experimental | Behavioral: Feedback plus incentivesSubjects receive feedback letters plus small incentives to increase healthy (green-labeled) purchases in the next month |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employee at Massachusetts General Hospital who uses a cafeteria debit card to pay for cafeteria purchases
Key exclusion criteria (2 listed)
- Employees who do not have a cafeteria debit card
- Employees with cafeteria debit card but who use it fewer than 3 times a month for the 3 months prior to start of trial
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 |
|---|---|---|
| Feedback lettersSubjects receive feedback letters about the proportion of green, yellow, and red purchases in the cafeteria per month with comparisons to "all employees" and to the "healthiest employees eaters" | Behavioural | Feedback only |
| Feedback plus incentivesSubjects receive feedback letters plus small incentives to increase healthy (green-labeled) purchases in the next month | Behavioural | Feedback plus incentives |
Primary outcome
Employee purchases of healthy (green-labeled) items
Time frame: 6 months
1 secondary outcome
Employee purchases of unhealthy (red-labeled) items
Time frame: 6 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 26827617Thorndike AN, Riis J, Levy DE. Social norms and financial incentives to promote employees' healthy food choices: A randomized controlled trial. Prev Med. 2016 May;86:12-8. doi: 10.1016/j.ypmed.2016.01.017. Epub 2016 Jan 29.
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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 Feedback letters and Feedback plus incentives in people with Food Labeling, 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 1 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. 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?
Employee purchases of healthy (green-labeled) items (time frame: 6 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 NCT01604499, 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.