Healthy Corner Store Initiative

Obesity Prevention Clinical Trial

— HCSI  

Official title:

Healthy Corner Store Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593749
• Other study ID #: NEP - 10520
• Secondary ID: 10520
• Status: Completed
• Phase: N/A
• First received: January 3, 2008
• Last updated: June 28, 2013
• Start date: September 2007
• Est. completion date: June 2010

Study information

• Verified date: January 2008
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The proposed research will evaluate the efficacy of an intervention in urban corner stores. Community-based, environmental manipulation of corner stores is an understudied area and represents the next step in understanding and improving the nutritional intake of school students to prevent obesity.

Description:

The HCSI is a community-based, multi-faceted, and broad-based intervention administered by The Food Trust. The HCSI is designed to permeate multiple aspects (i.e., social, educational, food availability) of the corner store environment. Moreover, it takes into account the unique aspects of each corner store.

Theoretical Framework. The HCSI is grounded in social cognitive theory (SCT). By incorporating the environment, personal factors (including cognitions) and behavior, SCT provides a framework for designing, implementing, and evaluating behavioral change. It supports traditional behavioral methods (positive reinforcement, specific behavioral outcomes). Moreover, it underscores the critical role of the social environment (modeling, social reinforcement, social norms - as well as reducing the antecedents for purchasing unhealthy foods) in affecting change. Our initial work has assessed the feasibility of implementing the HCSI and collecting data (see preliminary studies). We are poised to test the efficacy of the HCSI in the proposed study.

Behavioral Goals. The HCSI intervention seeks to: 1) decrease the purchase of high calorie snacks and beverages and to 2) increase the percentage of healthy snacks and beverages at the store level. Decreasing the purchase of high-calorie foods in the corner stores and/or decreasing sugar-sweetened soft drinks (assuming no change in physical activity) will shift energy balance to favor the prevention of overweight and obesity. These dietary goals are also consistent with the Institute of Medicine report on childhood obesity (Preventing Childhood Obesity: Health in the Balance, 2004). While we will measure BMI in the proposed study, our primary outcome of this initial randomized trial of efficacy is energy intake assessed at the time of purchase.

Although the implementation of the intervention will vary depending on the characteristics of the corner store, the major components of the program are summarized below:

Key informant interviews with corner store owners and teachers at local schools and after-school programs to determine how best to work with these key groups Social marketing campaign to reinforce messages about healthy snacking, Grouping healthy snacks and/or displaying signage for easy identification of healthier items, Integrating healthy snacking information into school and after-school programs to teach youngsters what comprises a healthy snack Involving family members and the community in promoting healthy snacking Working with snack and beverage manufacturers and distributors to increase the number of healthy snacks available in corner stores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• 4th, 5th and 6th grade students

• Schools who meet eligibility for 50% of students eligible to receive free or reduced lunches at their school

• Corner stores surrounding these schools within a 4 block radius in either direction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity Prevention

Intervention

Behavioral:
• Healthy Corner Store Initiative
modification of snacks and beverages offered in corner store surrounding 10 schools
• Control
control group in study

Locations

Country	Name	City	State
United States	Temple University - Center for Obesity Research and Education	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the intervention and control on changes, over a 2 year period, in the energy content of snacks purchased before and after school at corner stores.		post	No
Secondary	To compare the intervention and control groups on the percentage of available healthy snacks, the percentage of dedicated space for shelving healthy snacks, and the allocation of dedicated space where healthy items will be grouped for display.		post	No
Secondary	To understand the correlates and determinants of corner store shopping behavior.		post	No