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Dietary ModificationPhase 3NCT02574052

Medical College Students' Responds to Menu Labeling

A Phase 3 study testing participants' food choices, menu labelling without nutrition education and menu labelling with nutrition education in people with Dietary Modification, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.

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

The purpose of this study is to evaluate whether exposure to nutrition information with or without nutrition education would influence college students' dietary choices and improved the previous photographs-based dietary assessment tools. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Dietary Modification
What is being tested?
participants' food choices, menu labelling without nutrition education and menu labelling with nutrition education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Oct 2014to Dec 2014
Phase
Phase 3
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Grade 2012, 2013 undergraduate students and Grade 2013 graduate students

Who cannot join

  • Participants who sent the photographs less than six times in any one of the three meals at any stage
  • Participants who did not complete their questionnaires
  • Participants who withdrew from the experiment at any stage

About this study

Official title: Medical College Students' Responds to Menu Labeling With or Without Nutrition

The purpose of this study is to evaluate whether exposure to nutrition information with or without nutrition education would influence college students' dietary choices and improved the previous photographs-based dietary assessment tools.

Read the detailed description
  1. The investigators improved the previous photographs-based dietary assessment tools and utilized the improved approach to evaluate participants' calorie and nutrients intake.
  2. A pre-post non-controlled study design was implemented in the medical college and was divided into three stages: just recording the dietary selection in the three meals daily, recording the dietary selection with the provision of menu labeling accompanying with or without nutrition education. The investigators adopted photographs-based dietary assessment tools and a mobile phone application 'WeChat' was utilized as the photographs and nutrition knowledge transfer platform. Two professional researchers respectively read the received photographs and calculated participants' calorie and nutrients intake.
Being tested
participants' food choices, menu labelling without nutrition education, menu labelling with nutrition education
Keywords
Menu Labelling;, Nutrition Education;, dietary assessment tools;

What participants receive

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

  • participants' food choicesBehavioural

    just recorded the participants' food choices in the school cafeteria

  • menu labelling without nutrition educationBehavioural

    The investigators provided every participant with a menu labeling without any interpretation and recorded their dietary selections

  • menu labelling with nutrition educationBehavioural

    The investigators not only sent a menu labeling to every participant, but also delivered nutrition education to participants by providing them with nutrition and health knowledge through WeChat daily.

Study groups in NCT02574052
Study groupRoleWhat they receive
BehavioralOtherThe whole experiment was divided into three phases with each phase lasting two weeks. First Stage-Behavioral: just record participants' food choices Second Stage-Behavioral: menu labelling without nutrition education Third Stage- Behavioral; menu labelling with nutrition education
Receives: Behavioral: participants' food choices; Behavioral: menu labelling without nutrition education; Behavioral: menu labelling with nutrition education

What is being measured

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

  1. Descriptive Name of Scale: Composite outcome measure of calorie (kcal/day), protein(g/day), fat intake (g/day) and carbohydrate intake (g/day) of participants

    Through the receiving photographs the participants took about their three meals, the investigators estimated the calorie content (kcal/day), protein content (g/day), fat content (g/day), carbohydrate content (g/day) participants ate.

    Measured: up to six weeks

Timeline

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

  1. First posted12 Oct 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionNov 2014
  4. Study completionDec 2014

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02574052
Sponsor's protocol ID
XHEC-C-2014-094
Status last verified
Oct 2015
First submitted
7 Oct 2015
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Chu YH, Frongillo EA, Jones SJ, Kaye GL. Improving patrons' meal selections through the use of point-of-selection nutrition labels. Am J Public Health. 2009 Nov;99(11):2001-5. doi: 10.2105/AJPH.2008.153205. Epub 2009 Sep 17.

    PubMed 19762664

  • Harnack LJ, French SA, Oakes JM, Story MT, Jeffery RW, Rydell SA. Effects of calorie labeling and value size pricing on fast food meal choices: results from an experimental trial. Int J Behav Nutr Phys Act. 2008 Dec 5;5:63. doi: 10.1186/1479-5868-5-63.

    PubMed 19061510

  • Elbel B, Gyamfi J, Kersh R. Child and adolescent fast-food choice and the influence of calorie labeling: a natural experiment. Int J Obes (Lond). 2011 Apr;35(4):493-500. doi: 10.1038/ijo.2011.4. Epub 2011 Feb 15.

    PubMed 21326209

  • Finkelstein EA, Strombotne KL, Chan NL, Krieger J. Mandatory menu labeling in one fast-food chain in King County, Washington. Am J Prev Med. 2011 Feb;40(2):122-7. doi: 10.1016/j.amepre.2010.10.019.

    PubMed 21238859

  • Sinclair SE, Cooper M, Mansfield ED. The influence of menu labeling on calories selected or consumed: a systematic review and meta-analysis. J Acad Nutr Diet. 2014 Sep;114(9):1375-1388.e15. doi: 10.1016/j.jand.2014.05.014. Epub 2014 Jul 16.

    PubMed 25037558

  • Conklin MT, Cranage DA, Lambert CU. College students' use of point of selection nutrition information. Top Clin Nutr 2005;20:97-108.

  • Huybregts L, Roberfroid D, Lachat C, Van Camp J, Kolsteren P. Validity of photographs for food portion estimation in a rural West African setting. Public Health Nutr. 2008 Jun;11(6):581-7. doi: 10.1017/S1368980007000870. Epub 2007 Aug 9.

    PubMed 17686204

  • Lazarte CE, Encinas ME, Alegre C, Granfeldt Y. Validation of digital photographs, as a tool in 24-h recall, for the improvement of dietary assessment among rural populations in developing countries. Nutr J. 2012 Aug 29;11:61. doi: 10.1186/1475-2891-11-61.

    PubMed 22931128

  • Martin CK, Correa JB, Han H, Allen HR, Rood JC, Champagne CM, Gunturk BK, Bray GA. Validity of the Remote Food Photography Method (RFPM) for estimating energy and nutrient intake in near real-time. Obesity (Silver Spring). 2012 Apr;20(4):891-9. doi: 10.1038/oby.2011.344. Epub 2011 Dec 1.

    PubMed 22134199

  • Farley TA, Caffarelli A, Bassett MT, Silver L, Frieden TR. New York City's fight over calorie labeling. Health Aff (Millwood). 2009 Nov-Dec;28(6):w1098-109. doi: 10.1377/hlthaff.28.6.w1098. Epub 2009 Oct 6.

    PubMed 19808704

  • Roberto CA, Larsen PD, Agnew H, Baik J, Brownell KD. Evaluating the impact of menu labeling on food choices and intake. Am J Public Health. 2010 Feb;100(2):312-8. doi: 10.2105/AJPH.2009.160226. Epub 2009 Dec 17.

    PubMed 20019307

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing participants' food choices, menu labelling without nutrition education and menu labelling with nutrition education in people with Dietary Modification, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.

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 3 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Descriptive Name of Scale: Composite outcome measure of calorie (kcal/day), protein(g/day), fat intake (g/day) and carbohydrate intake (g/day) of participants (time frame: up to six weeks). 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 NCT02574052, which also lists 11 linked publications.

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 12 Oct 2015.

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