ObesityBHRRNCT02279849
Multi-level Communications and Access Strategies to Improve the Food Environment
A study testing Communications, Pricing and Combined (Communications & Pricing) in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The overarching goal of B'More Healthy Retail Rewards (BHRR) is to develop, implement, and evaluate a pilot multi-level communications and pricing intervention to improve access to and consumption of healthy foods in low-income areas of Baltimore City, Maryland. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Communications, Pricing and Combined (Communications & Pricing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2014
- Phase
- Interventional
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 yrs of age and a regular customer at participating corner store.
Who cannot join
- Under 21 years of age and not a regular customer of participating store.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-level Communications and Access Strategies to Improve the Food Environment:B'More Healthy: Retailer Rewards (BHRR)
The overarching goal of B'More Healthy Retail Rewards (BHRR) is to develop, implement, and evaluate a pilot multi-level communications and pricing intervention to improve access to and consumption of healthy foods in low-income areas of Baltimore City, Maryland. BHRR has three primary aims: (1) to conduct formative research with representatives of multiple levels of the Baltimore food environment (i.e., local wholesalers, retail food store owners, and consumers) in order to select key foods for promotion, and determine appropriate communications and healthy food price reduction strategies, (2) to pilot the multi-level program with 2 local wholesale stores, and 24 small corner stores and their customers, and assess program implementation through detailed process evaluation, and (3) to assess impact of multilevel health communications and pricing strategies, combined and separately, on consumer dietary patterns and food source use, food purchasing behaviors, psychosocial variables, food security, and individual weight and height.
Read the detailed description
Innovative and culturally appropriate multilevel health communications interventions are desperately needed to address the chronic disease epidemic in high-risk populations, such as low-income urban African Americans. However, the vast majority of communications strategies have focused on educating individual consumers about healthy food choices, while in poor urban settings the lower availability of affordable healthy food choices greatly limits the impact of these messages. The study team worked with 1 wholesaler and 24 small retail food stores to develop and test novel strategies in Baltimore, Maryland, including: 1) multilevel health communications alone directed at wholesalers, retailers and low-income African American consumers intended to enhance willingness to stock and/or purchase healthy foods; 2) pricing strategies (performance based allowances) directed at wholesalers and retailers to increase their stocking of healthy foods at reduced prices; and 3) combined health communications and pricing strategies. Intervention strategies were tailored to meet the needs of the target populations based on formative research and stakeholder input. This research study is based on significant field experience in this setting, including the development of evaluation tools to assess change in stocking and pricing of key foods (at the store level), and psychosocial factors, dietary intake, and food purchasing behaviors (at the consumer level). There are 3 main study aims:
- Formative research with representatives of multiple levels of the Baltimore food environment (i.e., local wholesalers and retail food store owners) in order to select key foods for promotion, determine appropriate communication strategies (e.g., messages, channels, materials) for each level, and select the most appropriate pricing approach (i.e., performance based allowance structure and stipulations).
- Pilot the multilevel program with three wholesalers and 24 food stores (6 control, 6 health communications only, 6 pricing only, 6 combined), and assess program implementation through detailed process evaluation.
- Assess impact of the pilot program on a) the stocking, pricing, marketing, and sales volume of promoted foods at wholesale and retail levels, and b) food purchasing behaviors and associated psychosocial variables (i.e., self-efficacy, intentions, perceived cost) at the consumer level (final sample n=12 consumers/store, 288 total).
The proposed research seeks to develop effective, multilevel communication strategies to improve diet and reduce risk for diet-related chronic diseases. The study team anticipates this design will demonstrate the value of a multi-pronged and multilevel health communications approach to obesity and chronic disease prevention, and will lead to a large-scale trial and informed policies designed to improve food availability and affordability in low-income urban settings.
- Conditions
- Obesity
- Being tested
- Communications, Pricing, Combined (Communications & Pricing)
- Keywords
- multi-level intervention, price discounts, communication, low income population, dietary intervention, obesity prevention, store-based intervention
- Medical subject headings
- Obesity, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommunicationsOther
Communication materials were used to promote healthier items to consumers in corner stores.
PricingOther
The pricing incentives were used to help promote sales of healthier food items.
Combined (Communications & Pricing)Other
Communications with Pricing incentives were used to promote the sale/consumption of healthier foods.
| Study group | Role | What they receive |
|---|---|---|
| Communications | Experimental | These 6 stores received the communications intervention. Communications materials were developed for each program phase; 1) Healthier Drinks, 2) Healthier Essentials, and 3) Healthier Snacks. Each phase's materials included posters, recipe cards, educational handouts, shelf talkers, price tags, door signs, educational displays, and promotional giveaways (i.e., drink tumblers, re-usable shopping bags) to encourage healthy food purchasing and consumption. Stores receiving the communications intervention also received either a small refrigerator or freezer to help provide the environmental supports needed to stock perishable fruits and vegetables. Receives: Other: Communications |
| Control | No intervention | These 6 stores received no intervention. |
| Pricing | Experimental | These 6 stores received a pricing intervention. 10-30% with discounts for specific foods contingent on price elasticity of demand, initial wholesale price, and projected store-level sales. Items were given the minimum discount needed to increase store supply and consumer demand. For example, brand name frozen vegetables were discounted 30% at the wholesaler, in order to provide the storeowner with enough incentive to stock the item. The % discount passed from the storeowner to the consumer was ultimately a decision made by the storeowner, but was suggested to be at least 50% in order to increase consumer demand. Discounts were automatically applied at wholesaler registers to stores receiving the pricing intervention. Receives: Other: Pricing |
| Combined (Communications & Pricing) | Experimental | These 6 stores received communications materials as well as pricing incentives as intervention (see Communications \& Pricing Arms Descriptions). Receives: Other: Combined (Communications & Pricing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy food purchasing and related-psychosocial factors
We analyzed the average change in consumer purchase of promoted foods and related consumer psychosocial variables across treatment groups from baseline and post-intervention by examine intervention effects by analyzing the change variable obtained by subtracting the pretest score from post-test score (exploratory analysis); and 2) conduct confirmatory testing of intervention effects using ANOVA and mixed models.
Measured: Up to 8 months
Secondary outcomes (1)
Consumer dietary intake and consumption of promoted foods
We analyzed the average change in consumer dietary intake and consumption of promoted foods across treatment groups from baseline and post-intervention by examine intervention effects by analyzing the change variable obtained by subtracting the pretest score from post-test score (exploratory analysis); and 2) conduct confirmatory testing of intervention effects using ANOVA and mixed models.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Gittelsohn, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279849
- Sponsor's protocol ID
- NIH110547
- Acronym
- BHRR
- Status last verified
- Mar 2018
- First submitted
- 18 Feb 2014
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Budd N, Cuccia A, Jeffries JK, Prasad D, Frick KD, Powell L, Katz FA, Gittelsohn J. B'More Healthy: Retail Rewards--design of a multi-level communications and pricing intervention to improve the food environment in Baltimore City. BMC Public Health. 2015 Mar 24;15:283. doi: 10.1186/s12889-015-1616-6.
PubMed 25885923
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Communications and Access Strategies to Improve the Food Environment:B'More Healthy: Retailer Rewards (BHRR)
- ClinicalTrials.gov ID
- NCT02279849
- Acronym / sponsor ID
- BHRR / NIH110547
- Conditions
- Obesity
- Keywords
- multi-level intervention, price discounts, communication, low income population, dietary intervention, obesity prevention, store-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 Oct 2014 (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.
The overarching goal of B'More Healthy Retail Rewards (BHRR) is to develop, implement, and evaluate a pilot multi-level communications and pricing intervention to improve access to and consumption of healthy foods in low-income areas of Baltimore City, Maryland. BHRR has three primary aims: (1) to conduct formative research with representatives of multiple levels of the Baltimore food environment (i.e., local wholesalers, retail food store owners, and consumers) in order to select key foods for promotion, and determine appropriate communications and healthy food price reduction strategies, (2) to pilot the multi-level program with 2 local wholesale stores, and 24 small corner stores and their customers, and assess program implementation through detailed process evaluation, and (3) to assess impact of multilevel health communications and pricing strategies, combined and separately, on consumer dietary patterns and food source use, food purchasing behaviors, psychosocial variables, food security, and individual weight and height.
Detailed description
Innovative and culturally appropriate multilevel health communications interventions are desperately needed to address the chronic disease epidemic in high-risk populations, such as low-income urban African Americans. However, the vast majority of communications strategies have focused on educating individual consumers about healthy food choices, while in poor urban settings the lower availability of affordable healthy food choices greatly limits the impact of these messages. The study team worked with 1 wholesaler and 24 small retail food stores to develop and test novel strategies in Baltimore, Maryland, including: 1) multilevel health communications alone directed at wholesalers, retailers and low-income African American consumers intended to enhance willingness to stock and/or purchase healthy foods; 2) pricing strategies (performance based allowances) directed at wholesalers and retailers to increase their stocking of healthy foods at reduced prices; and 3) combined health communications and pricing strategies. Intervention strategies were tailored to meet the needs of the target populations based on formative research and stakeholder input. This research study is based on significant field experience in this setting, including the development of evaluation tools to assess change in stocking and pricing of key foods (at the store level), and psychosocial factors, dietary intake, and food purchasing behaviors (at the consumer level). There are 3 main study aims:
- Formative research with representatives of multiple levels of the Baltimore food environment (i.e., local wholesalers and retail food store owners) in order to select key foods for promotion, determine appropriate communication strategies (e.g., messages, channels, materials) for each level, and select the most appropriate pricing approach (i.e., performance based allowance structure and stipulations).
- Pilot the multilevel program with three wholesalers and 24 food stores (6 control, 6 health communications only, 6 pricing only, 6 combined), and assess program implementation through detailed process evaluation.
- Assess impact of the pilot program on a) the stocking, pricing, marketing, and sales volume of promoted foods at wholesale and retail levels, and b) food purchasing behaviors and associated psychosocial variables (i.e., self-efficacy, intentions, perceived cost) at the consumer level (final sample n=12 consumers/store, 288 total).
The proposed research seeks to develop effective, multilevel communication strategies to improve diet and reduce risk for diet-related chronic diseases. The study team anticipates this design will demonstrate the value of a multi-pronged and multilevel health communications approach to obesity and chronic disease prevention, and will lead to a large-scale trial and informed policies designed to improve food availability and affordability in low-income urban settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Communications | Experimental | Other: CommunicationsThese 6 stores received the communications intervention. Communications materials were developed for each program phase; 1) Healthier Drinks, 2) Healthier Essentials, and 3) Healthier Snacks. Each phase's materials included posters, recipe cards, educational handouts, shelf talkers, price tags, door signs, educational displays, and promotional giveaways (i.e., drink tumblers, re-usable shopping bags) to encourage healthy food purchasing and consumption. Stores receiving the communications intervention also received either a small refrigerator or freezer to help provide the environmental supports needed to stock perishable fruits and vegetables. |
| Control | No intervention | –These 6 stores received no intervention. |
| Pricing | Experimental | Other: PricingThese 6 stores received a pricing intervention. 10-30% with discounts for specific foods contingent on price elasticity of demand, initial wholesale price, and projected store-level sales. Items were given the minimum discount needed to increase store supply and consumer demand. For example, brand name frozen vegetables were discounted 30% at the wholesaler, in order to provide the storeowner with enough incentive to stock the item. The % discount passed from the storeowner to the consumer was ultimately a decision made by the storeowner, but was suggested to be at least 50% in order to increase consumer demand. Discounts were automatically applied at wholesaler registers to stores receiving the pricing intervention. |
| Combined (Communications & Pricing) | Experimental | Other: Combined (Communications & Pricing)These 6 stores received communications materials as well as pricing incentives as intervention (see Communications \& Pricing Arms Descriptions). |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 21 yrs of age and a regular customer at participating corner store.
Key exclusion criteria (1 listed)
- Under 21 years of age and not a regular customer of participating store.
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 |
|---|---|---|
| CommunicationsCommunication materials were used to promote healthier items to consumers in corner stores. | Other | Communications |
| PricingThe pricing incentives were used to help promote sales of healthier food items. | Other | Pricing |
| Combined (Communications & Pricing)Communications with Pricing incentives were used to promote the sale/consumption of healthier foods. | Other | Combined (Communications & Pricing) |
Primary outcome
Healthy food purchasing and related-psychosocial factors
Time frame: Up to 8 months
We analyzed the average change in consumer purchase of promoted foods and related consumer psychosocial variables across treatment groups from baseline and post-intervention by examine intervention effects by analyzing the change variable obtained by subtracting the pretest score from post-test score (exploratory analysis); and 2) conduct confirmatory testing of intervention effects using ANOVA and mixed models.
1 secondary outcome
Consumer dietary intake and consumption of promoted foods
Time frame: Up to 8 months
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 27 Mar 2018.
- Derived from this study: PubMed 25885923Budd N, Cuccia A, Jeffries JK, Prasad D, Frick KD, Powell L, Katz FA, Gittelsohn J. B'More Healthy: Retail Rewards--design of a multi-level communications and pricing intervention to improve the food environment in Baltimore City. BMC Public Health. 2015 Mar 24;15:283. doi: 10.1186/s12889-015-1616-6.
- website detailing ongoing projects to improve the food environmentLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communications, Pricing and Combined (Communications & Pricing) in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health 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 1 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 27 Mar 2018. 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 purchasing and related-psychosocial factors (time frame: Up to 8 months). 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 NCT02279849, which also lists 1 linked publication.
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 27 Mar 2018.