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ObesitySNaXNCT01914471

A Randomized Controlled Trial of Students for Nutrition and eXercise

A study testing Students for Nutrition and eXercise in people with Obesity, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Students for Nutrition and eXercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,997 participants
Where
1 siteUnited States
Study dates
Sep 2008to Mar 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • RAND Corporation

    Santa Monica, California, 90401

Other trials in United States

About this study

Official title: 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.

Conditions
Obesity
Being tested
Students for Nutrition and eXercise
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Students for Nutrition and eXerciseBehavioural

    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

Study groups in NCT01914471
Study groupRoleWhat they receive
ControlNo interventionThese schools did not receive the intervention.
Students for Nutrition and eXerciseExperimentalThese 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
Receives: Behavioral: Students for Nutrition and eXercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 months

  2. Number of fruits and vegetables served per day

    We obtained the number of fruits and vegetables served per day from the school cafeterias.

    Measured: 5 months

Secondary outcomes (6)

  1. 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.

    Measured: 5 months

  2. Attitudes about water

    Attitudes about water were measured with a survey including an 11-point scale (very negatively/very positively).

    Measured: 5 months

  3. Knowledge about healthy eating and physical activity

    Knowledge about healthy eating and physical activity was measured with a survey containing 6 true/false items.

    Measured: 5 months

  4. 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).

    Measured: 5 months

  5. 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).

    Measured: 5 months

  6. Number of snacks sold per day

    We obtained the data on the number of snacks sold per day from the school store.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2013 (estimated)
  2. Study startSep 2008
  3. Primary completionJun 2012
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,997 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01914471
Sponsor's protocol ID
R24MD001648
Acronym
SNaX
Status last verified
Jul 2013
First submitted
29 Jul 2013
Last updated
2 Aug 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24784545

Questions about this trial

What is this clinical trial studying?

A study testing Students for Nutrition and eXercise in people with Obesity, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01914471, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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