Healthy Corner Store Initiative (HCSI)

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT00593749
First received: January 3, 2008
Last updated: June 28, 2013
Last verified: January 2008
  Purpose

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.


Condition Intervention
Obesity Prevention
Behavioral: Healthy Corner Store Initiative
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Healthy Corner Store Initiative

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • 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. [ Time Frame: post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: post ] [ Designated as safety issue: No ]
  • To understand the correlates and determinants of corner store shopping behavior. [ Time Frame: post ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: September 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HCS
Intervention group
Behavioral: Healthy Corner Store Initiative
modification of snacks and beverages offered in corner store surrounding 10 schools
Other Name: HCSI
Placebo Comparator: Control
Control
Behavioral: Control
control group in study

Detailed 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.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593749

Locations
United States, Pennsylvania
Temple University - Center for Obesity Research and Education
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Gary D Foster, PhD Temple University- Center for Obesity Research and Education
  More Information

No publications provided by Temple University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00593749     History of Changes
Other Study ID Numbers: NEP - 10520, 10520
Study First Received: January 3, 2008
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
obesity prevention
corner stores
schools

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014