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Modified Consent Form Utility

NCT ID: NCT00715923

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Modified consent form

Group Type EXPERIMENTAL

Modified consent form

Intervention Type OTHER

modified consent form used

2

Standard consent form

Group Type ACTIVE_COMPARATOR

Standard consent form

Intervention Type OTHER

standard consent form used

Interventions

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Modified consent form

modified consent form used

Intervention Type OTHER

Standard consent form

standard consent form used

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* participation in parent study, English speaking

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Alexander A. Kon, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander A Kon, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California Davis

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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200715802

Identifier Type: -

Identifier Source: org_study_id