Modified Consent Form Utility

Not Applicable

Terminated

• Conditions: Healthy
• Interventions: Other: Modified consent form; Other: Standard consent form

• Registration Number: NCT00715923
• Lead Sponsor: University of California, Davis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-07-11
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-15
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• participation in parent study, English speaking

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Modified consent form	Modified consent form
2	Standard consent form	Standard consent form

Primary Outcome Measures

Name	Time	Method
Subject satisfaction	close of parent study

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States