Evaluation of California's SB 19 Pupil Nutrition Act - Tabular View

Tracking Information

First Received Date ^ICMJE

August 28, 2003

Last Updated Date

October 26, 2005

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00067847 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Evaluation of California's SB 19 Pupil Nutrition Act

Official Title ^ICMJE

Brief Summary

Four California school districts will be randomized to early implementation of California's SB 19 Pupil Nutrition Act or to business as usual. Over 5000 4th, 5th and 7th graders will be evaluated at baseline, 4-month, and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity policies have had an impact on students' risk of excess body weight. The impact of early implementation of SB 19 on academic achievement will also be assessed.

Detailed Description

Four California school districts will be randomized to early implementation of California's SB 19 Pupil Nutrition Act or to business as usual.

The nutrition provisions in SB19 include assuring that NO elementary school sells carbonated beverages at any time and that no middle schools sell carbonated beverages until after the end of the lunch hour each day. The nutrition provisions also include some restrictions on the sale of high-fat, high-sugar snack foods as well as encouragement to make fruits and vegetables more available to students. The legislation further encourages school districts to invest more heavily in providing students with opportunities to be physically active. High schools are NOT affected by this legislation.

Over 5000 4th, 5th, and 7th graders from 28 schools will be evaluated at baseline, 4-month and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity policies have had an impact on students' risk of excess body weight. The principal outcome measure is sex- and age-adjusted BMI percentile as determined from the CDC growthchart percentiles. Other measures include waist circumference, time to complete one mile run/walk, and blood pressure.

The impact of early implementation of SB 19 on academic achievement will also be assessed, using students' standardized math and language arts achievement test scores.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Behavioral: State-directed nutrition policy change

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

5020

Completion Date

May 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

healthy 4th, 5th or 7th graders able to fill out a 30-minute questionnaire in English and able to participate in aerobic physical activity.

Gender

Both

Ages

8 Years to 14 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00067847

Responsible Party

Study ID Numbers ^ICMJE

ECSB19PNA

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

University of California, Los Angeles
University of California, Berkeley
California Department of Education
The California Endowment

Investigators ^ICMJE

Principal Investigator:

William J McCarthy, Ph.D.

WestEd-Los Alamitos & UCLA Division of Cancer Prevention and Control Research

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

October 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP