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Trial record 1 of 1 for:    NCT01924130
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School Breakfast Policy Initiative Study (SBPI)

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ClinicalTrials.gov Identifier: NCT01924130
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : August 30, 2016
Sponsor:
Collaborators:
The Food Trust
The School District of Philadelphia
Information provided by (Responsible Party):
Temple University

Brief Summary:
The purpose of this study is to develop and evaluate the effects of a school breakfast policy initiative (SBPI) on the incidence of overweight and obesity as well as breakfast patterns (both inside and outside of school) among 4th-6th grade children. The study integrates research, education and extension to promote healthy breakfast consumption among low-income children in urban schools and will leverage ongoing SNAP-Ed and the School Breakfast Program efforts.

Condition or disease Intervention/treatment Phase
Childhood Obesity Hunger Other: Classroom feeding Behavioral: Nutrition education lessons Behavioral: Social Marketing Behavioral: Parent outreach Not Applicable

Detailed Description:

Policy makers have promoted school breakfast participation as a tool to help prevent childhood obesity. No randomized controlled trials have examined the effects of a school breakfast feeding program on obesity. We propose to develop and evaluate a School Breakfast Policy Initiative (SBPI) that combines classroom feeding, in-school nutrition education, social marketing and parent outreach. Specifically, we will promote the benefits of a healthy breakfast at school or home and deter buying "breakfast" at corner stores where purchases are high in energy, solid fats and added sugars. This intervention will be evaluated in the "real world" of urban schools that make frequent use of the SNAP-Ed and the School Breakfast Program. The specific aims are:

  1. To develop the SBPI intervention within the context of SNAP Ed and the National School Breakfast Program in the School District of Philadelphia.
  2. To conduct a pilot feasibility study among 4 schools (2 intervention and 2 control) to assess feasibility and acceptability.
  3. To compare participants in the intervention (n=8) and comparison schools (n=8) on the incidence of overweight and obesity. We predict that intervention schools, compared to the comparison schools, will have a significantly lower incidence rate of overweight and obesity over a 2 y period.
  4. To compare participants in the intervention (n=8) and comparison schools (n=8) on eating one breakfast. We predict that intervention schools, compared to the comparison schools, will have significantly greater percentage of children eating one breakfast per day over a 2 y period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increasing Breakfast Consumption and Decreasing Childhood Obesity Among Low-income, Ethnically Diverse Youth.
Study Start Date : July 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: One Healthy Breakfast Program
Classroom feeding, nutrition education lessons, social marketing, and parent outreach.
Other: Classroom feeding
Students are fed breakfast in the classroom at the start of the school, rather than the cafeteria before school.

Behavioral: Nutrition education lessons
Students receive breakfast specific nutrition education lessons.

Behavioral: Social Marketing
A social marketing campaign designed to promote consumption of one healthy breakfast a day. The marketing includes a healthy breakfast points-based reward program designed by the students and promotional campaigns.

Behavioral: Parent outreach
A variety of communication methods that engage families and offer education that meets their needs, including school breakfast menus, parent newsletters, and information tables at parent-teacher meetings.

No Intervention: Control
Only receive assessments.



Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: Pilot Study: baseline (September-October 2012), 8-9 month follow up (May 2014). Main Trial: baseline (September-December 2013), 16 month follow up (January-March 2015), 32 month follow up (April-June 2016) ]
    BMI is calculated using students' height and weight measurements.

  2. Breakfast Consumption habits [ Time Frame: Pilot Study: baseline (September-October 2012), 8-9 month follow up (May 2014). Main Trial: baseline (September-December 2013), 16 month follow up (January-March 2015), 32 month follow up (April-June 2016) ]
    Measured using a breakfast intake questionnaire.

  3. Hunger [ Time Frame: Pilot Study: baseline (September-October 2012), 8-9 month follow up (May 2014). Main Trial: baseline (September-December 2013), 16 month follow up (January-March 2015), 32 month follow up (April-June 2016) ]
    Measured using a hunger scale questionnaire.

  4. School meal participation rates [ Time Frame: Every month for 34 months (September 2013-June 2016) ]


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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 4th-8th grade Philadelphia public school students.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924130


Locations
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United States, Pennsylvania
Temple University - Center for Obesity Research and Education
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
The Food Trust
The School District of Philadelphia
Investigators
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Principal Investigator: Jennifer O Fisher, PhD Temple University - Center for Obesity Research and Education
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01924130    
Other Study ID Numbers: 20452
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight