- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01990508
Randomized Trial of Financial Incentives to Reduce Sugar-sweetened Beverage Purchases by Low-income, Latino Families
October 2, 2015 updated by: Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
216
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- purchase >75% of groceries at targeted supermarket (regular customer)
- at least one child <= 18 years old living at home
Exclusion Criteria:
- not fluent in Spanish or English
- no address or phone for contact
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Targeted beverage education and financial incentives
Study subjects receive monthly letters with beverage education and financial incentives for not purchasing sugar-sweetened beverages
|
All beverages in the supermarket will be labeled as red, yellow, or green
|
|
Sham Comparator: Control
Monthly letters with generic nutrition information only
|
All beverages in the supermarket will be labeled as red, yellow, or green
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Purchase of sugar-sweetened beverages
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Consumption of sugar-sweetened beverages
Time Frame: 4 months
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Purchase of red-labeled beverages
Time Frame: 6 months
|
Pre-post evaluation of purchase of red-labeled beverages before and after the labels are in place
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne N Thorndike, MD, MPH, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
November 15, 2013
First Submitted That Met QC Criteria
November 15, 2013
First Posted (Estimate)
November 21, 2013
Study Record Updates
Last Update Posted (Estimate)
October 6, 2015
Last Update Submitted That Met QC Criteria
October 2, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013P001130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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