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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Students for Nutrition and eXercise
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • RAND Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Students for Nutrition and eXercise

Arm Description

These schools did not receive the intervention.

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

Outcomes

Primary Outcome Measures

Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility
We obtained the number of students obtaining lunch per day (by National School Lunch Program (NSLP) eligibility) from schools.
Number of fruits and vegetables served per day
We obtained the number of fruits and vegetables served per day from the school cafeterias.

Secondary Outcome Measures

Attitudes about the cafeteria
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.
Attitudes about water
Attitudes about water were measured with a survey including an 11-point scale (very negatively/very positively).
Knowledge about healthy eating and physical activity
Knowledge about healthy eating and physical activity was measured with a survey containing 6 true/false items.
Intentions to drink water
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).
Water consumption frequency
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).
Number of snacks sold per day
We obtained the data on the number of snacks sold per day from the school store.

Full Information

First Posted
July 29, 2013
Last Updated
August 1, 2013
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01914471
Brief Title
A Randomized Controlled Trial of Students for Nutrition and eXercise
Acronym
SNaX
Official Title
A Community-Academic Partnership to Address Disparities in Obesity Among Youth
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2997 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
These schools did not receive the intervention.
Arm Title
Students for Nutrition and eXercise
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Students for Nutrition and eXercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility
Description
We obtained the number of students obtaining lunch per day (by National School Lunch Program (NSLP) eligibility) from schools.
Time Frame
5 months
Title
Number of fruits and vegetables served per day
Description
We obtained the number of fruits and vegetables served per day from the school cafeterias.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Attitudes about the cafeteria
Description
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.
Time Frame
5 months
Title
Attitudes about water
Description
Attitudes about water were measured with a survey including an 11-point scale (very negatively/very positively).
Time Frame
5 months
Title
Knowledge about healthy eating and physical activity
Description
Knowledge about healthy eating and physical activity was measured with a survey containing 6 true/false items.
Time Frame
5 months
Title
Intentions to drink water
Description
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).
Time Frame
5 months
Title
Water consumption frequency
Description
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).
Time Frame
5 months
Title
Number of snacks sold per day
Description
We obtained the data on the number of snacks sold per day from the school store.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A. Schuster, MD, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAND Corporation
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24784545
Citation
Bogart LM, Cowgill BO, Elliott MN, Klein DJ, Hawes-Dawson J, Uyeda K, Elijah J, Binkle DG, Schuster MA. A randomized controlled trial of students for nutrition and eXercise: a community-based participatory research study. J Adolesc Health. 2014 Sep;55(3):415-22. doi: 10.1016/j.jadohealth.2014.03.003. Epub 2014 Apr 29.
Results Reference
derived

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A Randomized Controlled Trial of Students for Nutrition and eXercise

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