Food PolicySTORENCT02774330
Impact of the Minneapolis Staple Foods Ordinance
An observational study of Food Policy, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Policy
- What is being tested?
- Policy
- How many people
- 3,488 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Customers exiting small- to mid-size food stores after having purchased a food or beverage item
Who may be able to join
- 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
Show all 10Show fewer
- >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
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Division of Epidemiology and Community Health
Minneapolis, Minnesota, 55454
About this study
Official title: 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.
Read the 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.
- Conditions
- Food Policy
- Being tested
- Policy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Policy | |
| St. Paul, Minnesota Customers | No policy exists in St. Paul, Minnesota. This is the control condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 24 months post-policy implementation (i.e., 12-months post-policy enforcement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startSep 2014
- Primary completion18 Dec 2017
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Food PolicyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,488 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Melissa N Laska, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774330
- Sponsor's protocol ID
- 1311S45924
- Other IDs
- 1410S54204, R01DK104348, U48DP005022
- Acronym
- STORE
- Status last verified
- Jan 2019
- First submitted
- 4 May 2016
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 32019508Laska 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.
PubMed 31533737Caspi 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.
PubMed 28583131
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Local Staple Foods Ordinance on Food Choice and Calories Purchased
- ClinicalTrials.gov ID
- NCT02774330
- Acronym / sponsor ID
- STORE / 1311S45924
- Conditions
- Food Policy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,488 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Centers for Disease Control and Prevention
- Study start
- Sep 2014 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minneapolis, Minnesota Customers | – | Other: PolicyMinneapolis, 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. |
| St. Paul, Minnesota Customers | – | –No policy exists in St. Paul, Minnesota. This is the control condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Customers exiting small- to mid-size food stores after having purchased a food or beverage item
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolicyThis 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. | Other | Minneapolis, Minnesota Customers |
Primary outcome
Healthy Food Supply (store-level)
Time frame: 24 months post-policy implementation (i.e., 12-months post-policy enforcement)
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).
Calories purchased (customer-level)
Time frame: 24 months post-policy implementation (i.e., 12-months post-policy enforcement)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Derived from this study: PubMed 32019508Caspi 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.
- Derived from this study: PubMed 31533737Laska 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.
- Derived from this study: PubMed 28583131Caspi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa N Laska, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Policy, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Food Supply (store-level) (time frame: 24 months post-policy implementation (i.e., 12-months post-policy enforcement)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02774330, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.