NCT01990508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

November 15, 2013

Last Update Submit

October 2, 2015

Conditions

Keywords

sugar-sweetened beveragestraffic-light labelsfinancial incentiveslow-income communityobesity prevention

Outcome Measures

Primary Outcomes (1)

  • Purchase of sugar-sweetened beverages

    4 months

Secondary Outcomes (1)

  • Consumption of sugar-sweetened beverages

    4 months

Other Outcomes (1)

  • Purchase of red-labeled beverages

    6 months

Study Arms (2)

Targeted beverage education and financial incentives

EXPERIMENTAL

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

Behavioral: Targeted beverage education and financial incentivesBehavioral: Traffic-light labeling of all beverages in store

Control

SHAM COMPARATOR

Monthly letters with generic nutrition information only

Behavioral: Traffic-light labeling of all beverages in store

Interventions

Targeted beverage education and financial incentives

All beverages in the supermarket will be labeled as red, yellow, or green

ControlTargeted beverage education and financial incentives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • purchase \>75% of groceries at targeted supermarket (regular customer)
  • at least one child \<= 18 years old living at home

You may not qualify if:

  • not fluent in Spanish or English
  • no address or phone for contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Anne N Thorndike, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 21, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 6, 2015

Record last verified: 2015-10

Locations