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Clinical Trials/NCT01924130
NCT01924130CompletedNot Applicable

Increasing Breakfast Consumption and Decreasing Childhood Obesity Among Low-income, Ethnically Diverse Youth.

Temple University2 sites in 1 country2,000 target enrollmentStarted: July 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,000
Locations
2
Primary Endpoint
Breakfast Consumption habits

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
7 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

One Healthy Breakfast Program

Experimental

Classroom feeding, nutrition education lessons, social marketing, and parent outreach.

Intervention: Nutrition education lessons (Behavioral)

Control

No Intervention

Only receive assessments.

One Healthy Breakfast Program

Experimental

Classroom feeding, nutrition education lessons, social marketing, and parent outreach.

Intervention: Classroom feeding (Other)

One Healthy Breakfast Program

Experimental

Classroom feeding, nutrition education lessons, social marketing, and parent outreach.

Intervention: Social Marketing (Behavioral)

One Healthy Breakfast Program

Experimental

Classroom feeding, nutrition education lessons, social marketing, and parent outreach.

Intervention: Parent outreach (Behavioral)

Outcomes

Primary Outcomes

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.

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.

School meal participation rates

Time Frame: Every month for 34 months (September 2013-June 2016)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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