- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593749
Healthy Corner Store Initiative (HCSI)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Temple University - Center for Obesity Research and Education
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
control group in study
|
Active Comparator: HCS
Intervention group
|
modification of snacks and beverages offered in corner store surrounding 10 schools
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
post
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
post
|
To understand the correlates and determinants of corner store shopping behavior.
Time Frame: post
|
post
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gary D Foster, PhD, Temple University- Center for Obesity Research and Education
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEP - 10520
- 10520 (Registry Identifier: DAIDS ES Registry ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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