- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01914471
A Randomized Controlled Trial of Students for Nutrition and eXercise (SNaX)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Santa Monica, California, United States, 90401
- RAND Corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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
Sponsor
Investigators
- Principal Investigator: Mark A. Schuster, MD, PhD, Boston Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R24MD001648 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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