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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01990508
Other study ID # 2013P001130
Secondary ID
Status Completed
Phase N/A
First received November 15, 2013
Last updated October 2, 2015
Start date January 2014
Est. completion date September 2014

Study information

Verified date October 2015
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Targeted beverage education and financial incentives

Traffic-light labeling of all beverages in store
All beverages in the supermarket will be labeled as red, yellow, or green

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Harvard School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Purchase of red-labeled beverages Pre-post evaluation of purchase of red-labeled beverages before and after the labels are in place 6 months No
Primary Purchase of sugar-sweetened beverages 4 months No
Secondary Consumption of sugar-sweetened beverages 4 months No
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