A Randomized Controlled Trial of Students for Nutrition and eXercise (SNaX)

August 1, 2013 updated by: Boston Children's Hospital

A Community-Academic Partnership to Address Disparities in Obesity Among Youth

Objectives: We conducted a randomized controlled trial (RCT) of Students for Nutrition and eXercise (SNaX), a middle-school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education and marketing.

Methods: We randomly selected schools from the Los Angeles Unified School District (LAUSD) and assigned five to the intervention group and five to a wait-list control group. School records were obtained for number of fruits and vegetables served, students served lunch, and snacks sold per attending student. Pre- and post-intervention surveys assessed psychosocial variables among 2,997 seventh-graders (75% of all seventh-graders across schools).

Hypotheses: For the RCT of SNaX, we hypothesized that SNaX would lead to increases in the proportion of students served in the cafeteria (because SNaX markets cafeterias' healthy foods); increased fruit and vegetable servings (because SNaX increases access to sliced/bite-sized fruits and vegetables); decreased school store snack sales; and greater water consumption. We also hypothesized that SNaX would lead to more positive attitudes about the cafeteria and water, improve obesity-prevention knowledge, and increase intentions to drink water.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

2997

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Santa Monica, California, United States, 90401
        • RAND Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • schools with >50% NSLP-eligible students (a proxy for low-income) and <900 - seventh-graders

Exclusion Criteria:

  • schools with <50% NSLP-eligible students and >900 seventh-graders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: Control
These schools did not receive the intervention.
Experimental: Students for Nutrition and eXercise
These schools received the entirety of Students for Nutrition and eXercise, a middle-school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education and marketing
These schools received the entirety of Students for Nutrition and eXercise, a middle-school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education and marketing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility
Time Frame: 5 months
We obtained the number of students obtaining lunch per day (by National School Lunch Program (NSLP) eligibility) from schools.
5 months
Number of fruits and vegetables served per day
Time Frame: 5 months
We obtained the number of fruits and vegetables served per day from the school cafeterias.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attitudes about the cafeteria
Time Frame: 5 months
Attitudes about the cafeteria were calculated by survey data using the mean of two 7-point scales representing attitudes about the cafeteria: unsatisfying/satisfying and bad for my health/good for my health.
5 months
Attitudes about water
Time Frame: 5 months
Attitudes about water were measured with a survey including an 11-point scale (very negatively/very positively).
5 months
Knowledge about healthy eating and physical activity
Time Frame: 5 months
Knowledge about healthy eating and physical activity was measured with a survey containing 6 true/false items.
5 months
Intentions to drink water
Time Frame: 5 months
Intentions to drink water were assessed with two survey items, "How likely is it that you will drink water [or drink water from a refillable water bottle] the next day you are in school?" with 5-point scales (extremely likely/extremely unlikely).
5 months
Water consumption frequency
Time Frame: 5 months
Water consumption frequency was assessed by survey with, "How often do you usually drink tap water?" and "How often do you usually use a refillable water bottle to drink water?" (every day, a few times a week, once a week, twice a month, once a month, less than once a month, never).
5 months
Number of snacks sold per day
Time Frame: 5 months
We obtained the data on the number of snacks sold per day from the school store.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark A. Schuster, MD, PhD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • R24MD001648 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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