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Randomized Trial of Financial Incentives to Reduce Sugar-sweetened Beverage Purchases by Low-income, Latino Families

Primary Purpose

Obesity Prevention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted beverage education and financial incentives
Traffic-light labeling of all beverages in store
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity Prevention focused on measuring sugar-sweetened beverages, traffic-light labels, financial incentives, low-income community, obesity prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Targeted beverage education and financial incentives

Control

Arm Description

Study subjects receive monthly letters with beverage education and financial incentives for not purchasing sugar-sweetened beverages

Monthly letters with generic nutrition information only

Outcomes

Primary Outcome Measures

Purchase of sugar-sweetened beverages

Secondary Outcome Measures

Consumption of sugar-sweetened beverages

Full Information

First Posted
November 15, 2013
Last Updated
October 2, 2015
Sponsor
Massachusetts General Hospital
Collaborators
Harvard School of Public Health (HSPH)
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1. Study Identification

Unique Protocol Identification Number
NCT01990508
Brief Title
Randomized Trial of Financial Incentives to Reduce Sugar-sweetened Beverage Purchases by Low-income, Latino Families
Official Title
Randomized Trial of Financial Incentives to Reduce Sugar-sweetened Beverage Purchases by Low-income, Latino Families
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Harvard School of Public Health (HSPH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Prevention
Keywords
sugar-sweetened beverages, traffic-light labels, financial incentives, low-income community, obesity prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted beverage education and financial incentives
Arm Type
Experimental
Arm Description
Study subjects receive monthly letters with beverage education and financial incentives for not purchasing sugar-sweetened beverages
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Monthly letters with generic nutrition information only
Intervention Type
Behavioral
Intervention Name(s)
Targeted beverage education and financial incentives
Intervention Type
Behavioral
Intervention Name(s)
Traffic-light labeling of all beverages in store
Intervention Description
All beverages in the supermarket will be labeled as red, yellow, or green
Primary Outcome Measure Information:
Title
Purchase of sugar-sweetened beverages
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Consumption of sugar-sweetened beverages
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Purchase of red-labeled beverages
Description
Pre-post evaluation of purchase of red-labeled beverages before and after the labels are in place
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne N Thorndike, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29493476
Citation
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.
Results Reference
derived

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Randomized Trial of Financial Incentives to Reduce Sugar-sweetened Beverage Purchases by Low-income, Latino Families

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