- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774330
Impact of the Minneapolis Staple Foods Ordinance (STORE)
January 22, 2019 updated by: University of Minnesota
Impact of a Local Staple Foods Ordinance on Food Choice and Calories Purchased
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.
Study Overview
Detailed Description
The aim of this study is to evaluate the impact of a local policy change (i.e., the Minneapolis Staple Foods Ordinance) that establishes minimum stocking criteria for a wide array of healthy foods as a requirement of food store licensing.
Recent calls to action from the Institute of Medicine, the Centers for Disease Control and Prevention and other authorities have identified improving access to healthy foods as a primary strategy for local governments to use in advancing obesity prevention efforts, but policy initiatives in this area have been limited.
In this study, the impact of the Minneapolis Staple Foods Ordinance will be evaluated by assessing objectively measured changes in: (a) food environments among small- to mid-sized, urban food stores, including availability, promotion, advertising, quality, price, and placement of both healthy and unhealthy foods and beverages, (b) nutritional quality of consumer purchases at small food stores, including assessment of energy density and calories via customer intercept surveys and direct observation of purchases and (c) home food environments, including availability of healthy and unhealthy foods/beverages and an overall home food obesogenicity score, among households that frequently shop at small- to mid-sized stores.
These changes will be assessed pre-policy implementation, as well as 4-, 12- and 24-months post-policy implementation, in two Minnesota cities: Minneapolis and St. Paul, (our control community).
The proposed scope of work in this study is important because its takes advantage of a unique opportunity to evaluate an innovative local policy addressing a recommended action area for obesity prevention that aligns with key recommendations by leading obesity prevention authorities.
To our knowledge, the Minneapolis Staple Food Ordinance is the only policy of its kind in the US, and as such it could serve as an important model policy for other local governments if it is successful.
Study Type
Observational
Enrollment (Actual)
3488
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
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- University of Minnesota, Division of Epidemiology and Community Health
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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
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Customers exiting small- to mid-size food stores after having purchased a food or beverage item
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not meeting inclusion criteria
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
St. Paul, Minnesota Customers
No policy exists in St. Paul, Minnesota.
This is the control condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Healthy Food Supply (store-level)
Time Frame: 24 months post-policy implementation (i.e., 12-months post-policy enforcement)
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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).
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24 months post-policy implementation (i.e., 12-months post-policy enforcement)
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Calories purchased (customer-level)
Time Frame: 24 months post-policy implementation (i.e., 12-months post-policy enforcement)
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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).
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24 months post-policy implementation (i.e., 12-months post-policy enforcement)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthy home food availability/obesogenicity score (customer-level)
Time Frame: 24 months post-policy implementation (i.e., 12-months post-policy enforcement)
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Trained staffers will visit the homes of participants who report frequently shopping in small- and non-traditional food stores to complete a home food inventory using a validated assessment tool.
(See Fulkerson et al, International Journal of Behavioral Nutrition and Physical Activity 2008;5(55).)
Data collected using this tool will be used to create a validated summative obesogenicity score, as detailed in Fulkerson et al 2008.
Changes in this score will be examined over time.
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24 months post-policy implementation (i.e., 12-months post-policy enforcement)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Melissa N Laska, PhD, University of Minnesota
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.
General Publications
- 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.
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 (Actual)
September 1, 2014
Primary Completion (Actual)
December 18, 2017
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
May 4, 2016
First Submitted That Met QC Criteria
May 16, 2016
First Posted (Estimate)
May 17, 2016
Study Record Updates
Last Update Posted (Actual)
January 24, 2019
Last Update Submitted That Met QC Criteria
January 22, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 1311S45924
- 1410S54204 (Other Identifier: University of Minnesota Institutional Review Board)
- R01DK104348 (U.S. NIH Grant/Contract)
- U48DP005022 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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