NCT02774330

Brief Summary

Improving healthy food availability and decreasing the availability of high calorie, low nutrient products, particularly in underserved communities, has been identified as a leading strategy for local governments to prevent obesity. However, policy action in this area to date has been limited. This R01 will examine the impact of a local policy change that establishes minimum stocking criteria for a wide array of healthy foods as a requirement of food store licensing. To our knowledge, this is the only policy of its kind in the US. As such, if it is successful, it could serve as an important model policy for other local governments seeking to increase healthy food availability and prevent obesity through local policy action.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,488

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

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

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

May 4, 2016

Last Update Submit

January 22, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Healthy Food Supply (store-level)

    To assess changes in healthy and unhealthy food availability, we will use a tool developed at the Yale Rudd Center for Food Policy and Obesity to evaluate the impact of 2009 Special Supplemental Nutrition Program for Women, Infants, and Children policy revisions in small stores, with minor adaptations to suit the needs of our study (See Andreyeva et al, J Acad Nutr Diet. 2012;112(6):850-858). As detailed in Andreyeva et al, we will create and use an an adapted Healthy Food Supply (HFS) score that summarizes availability, price, quality, and variety in the stores in our sample.We will examine changes in healthy food supply scores over time in stores in our sample in Minneapolis (where the policy is in place, i.e., our "intervention" community) versus those in St. Paul (where no such policy exists, i.e., our "control" community).

    24 months post-policy implementation (i.e., 12-months post-policy enforcement)

  • Calories purchased (customer-level)

    Our staff will examine all foods and beverages purchased (via a "bag check") by participating customers existing stores in our sample and will record item names, product types and weights/sizes. We will conduct detailed nutrient analyses on these purchases to assess total calories purchased and possible changes in calories purchased over time, comparing relative changes in purchasing among participants recruited outside of stores in Minneapolis (where the policy is in place, i.e., our "intervention" community) versus those in St. Paul (where no such policy exists, i.e., our "control" community).

    24 months post-policy implementation (i.e., 12-months post-policy enforcement)

Other Outcomes (1)

  • Healthy home food availability/obesogenicity score (customer-level)

    24 months post-policy implementation (i.e., 12-months post-policy enforcement)

Study Arms (2)

Minneapolis, Minnesota Customers

Minneapolis, Minnesota has a policy in place whereby minimum quantities and varieties of healthy food are required for all licensed food stores. The policy is our "intervention" condition.

Other: Policy

St. Paul, Minnesota Customers

No policy exists in St. Paul, Minnesota. This is the control condition.

Interventions

PolicyOTHER

This local policy change (i.e., the Minneapolis Staple Foods Ordinance) establishes minimum stocking criteria for a wide array of healthy foods as a requirement of food store licensing. To our knowledge, it is the first and only policy of its kind in the U.S. This Staple Foods Ordinance requires stores to stock specific types of foods in minimum quantities and varieties, including fruits and vegetables, low-fat dairy, and whole grains. A full list of all requirements can be found online through the City of Minneapolis: http://www.minneapolismn.gov/health/living/eating/staple-foods.

Minneapolis, Minnesota Customers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Customers exiting small- to mid-size food stores after having purchased a food or beverage item

You may qualify if:

  • Must be 18 years of age or older
  • Must be able to speak and understand English
  • Must have purchased at least one food or beverage item from a randomly selected store that meets the following criteria:
  • Outside the central downtown commercial core
  • Not authorized to accept benefits from the Special Supplemental Nutrition Program for Women, Infants, and Children
  • Valid licensing address
  • \>100 square feet of retail floor space
  • Not small vendors in market areas or specialty stores
  • Non-supermarket
  • Permission from store staff to recruit participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota, Division of Epidemiology and Community Health

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (3)

  • Caspi CE, Winkler MR, Lenk KM, Harnack LJ, Erickson DJ, Laska MN. Store and neighborhood differences in retailer compliance with a local staple foods ordinance. BMC Public Health. 2020 Feb 4;20(1):172. doi: 10.1186/s12889-020-8174-2.

  • Laska MN, Caspi CE, Lenk K, Moe SG, Pelletier JE, Harnack LJ, Erickson DJ. Evaluation of the first U.S. staple foods ordinance: impact on nutritional quality of food store offerings, customer purchases and home food environments. Int J Behav Nutr Phys Act. 2019 Sep 18;16(1):83. doi: 10.1186/s12966-019-0818-1.

  • Caspi CE, Lenk K, Pelletier JE, Barnes TL, Harnack L, Erickson DJ, Laska MN. Association between store food environment and customer purchases in small grocery stores, gas-marts, pharmacies and dollar stores. Int J Behav Nutr Phys Act. 2017 Jun 5;14(1):76. doi: 10.1186/s12966-017-0531-x.

MeSH Terms

Interventions

Policy

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Study Officials

  • Melissa N Laska, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 17, 2016

Study Start

September 1, 2014

Primary Completion

December 18, 2017

Study Completion

November 30, 2018

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations