NCT00593749

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 1, 2013

Status Verified

January 1, 2008

Enrollment Period

2.8 years

First QC Date

January 3, 2008

Last Update Submit

June 28, 2013

Conditions

Keywords

obesity preventioncorner storesschools

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • To understand the correlates and determinants of corner store shopping behavior.

    post

Study Arms (2)

HCS

ACTIVE COMPARATOR

Intervention group

Behavioral: Healthy Corner Store Initiative

Control

PLACEBO COMPARATOR

Control

Behavioral: Control

Interventions

modification of snacks and beverages offered in corner store surrounding 10 schools

Also known as: HCSI
HCS
ControlBEHAVIORAL

control group in study

Control

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • th, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University - Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • Borradaile KE, Sherman S, Vander Veur SS, McCoy T, Sandoval B, Nachmani J, Karpyn A, Foster GD. Snacking in children: the role of urban corner stores. Pediatrics. 2009 Nov;124(5):1293-8. doi: 10.1542/peds.2009-0964. Epub 2009 Oct 12.

Study Officials

  • Gary D Foster, PhD

    Temple University- Center for Obesity Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

September 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 1, 2013

Record last verified: 2008-01

Locations