Clinical trial NCT01914471: A Randomized Controlled Trial of Students for Nutrition and eXercise
Official title: A Community-Academic Partnership to Address Disparities in Obesity Among Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 2997
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility
timeFrame: 5 months
measure: Number of fruits and vegetables served per day
timeFrame: 5 months
Secondary outcomes:
measure: Attitudes about the cafeteria
timeFrame: 5 months
measure: Attitudes about water
timeFrame: 5 months
measure: Knowledge about healthy eating and physical activity
timeFrame: 5 months
measure: Intentions to drink water
timeFrame: 5 months
measure: Water consumption frequency
timeFrame: 5 months
measure: Number of snacks sold per day
timeFrame: 5 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: RAND Corporation
state: California
Study officials:
affiliation: Boston Children's Hospital
name: Mark A. Schuster, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.