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Modified Consent Form Utility

NCT00715923 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-12-03

No results posted yet for this study

Summary

Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be randomized to receive either a standard informed consent document or a modified document that is shorter and more easily understood than the standard document. The hypothesis is that using a shorter form that is more easily understood and more visually simple will lead to greater subject satisfaction in the consent process and will not compromise subject comprehension of key study aspects. Consent for study inclusion has been waived by the IRB because informing subjects of the nature and process of the study would likely affect the findings, and both the standard and modified consent forms were approved for use in the nutrition study.

Conditions

  • Healthy

Interventions

OTHER

Modified consent form

modified consent form used

OTHER

Standard consent form

standard consent form used

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Alexander A Kon, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-09-30
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00715923 on ClinicalTrials.gov