Clinical trial NCT02279849: Multi-level Communications and Access Strategies to Improve the Food Environment
Official title: Multi-level Communications and Access Strategies to Improve the Food Environment:B'More Healthy: Retailer Rewards (BHRR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: multi-level intervention
price discounts
communication
low income population
dietary intervention
obesity prevention
store-based intervention
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 444
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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. 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:

1. 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).
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 21 yrs of age and a regular customer at participating corner store.

Exclusion Criteria:

* Under 21 years of age and not a regular customer of participating store.

Primary outcomes:
measure: Healthy food purchasing and related-psychosocial factors
timeFrame: Up to 8 months
Secondary outcomes:
measure: Consumer dietary intake and consumption of promoted foods
timeFrame: Up to 8 months
Other outcomes:
measure: Store owner psychosocial variables to stock/sell promoted foods
timeFrame: Up to 8 months
measure: Sales of promoted foods
timeFrame: Up to 8 months
measure: Consumer Body Mass Index (BMI)
timeFrame: Up to 11 months
measure: Household food security, food assistance, health beliefs, socio-demographics
timeFrame: Up to 11 months
measure: Wholesaler sales of promoted foods
timeFrame: Up to 8 months
measure: Process Evaluation
timeFrame: Up to 8 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
References:
citation: 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.