Development and Validation of the Food Acceptability Ques... | NCT00412724

Studies
Development and Validation of the Food Acceptability Questionnaire

NCT00412724

Sponsor

Physicians Committee for Responsible Medicine

Status

Completed

Last Update Posted

Aug 7, 2012Estimated

Enrollment

189Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Dec 14, 2006

First Submission Date that Met QC Criteria

Dec 15, 2006

First Posted Date

Dec 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2012

Last Update Posted Date

Aug 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Food Acceptability Questionnaire (FAQ) is a self-report measure of palatability, ease of preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed or self-selected diet. This study intends to develop a reliable and valid food acceptability questionnaire for use in clinical studies in which dietary interventions are administered.

Detailed Description

Two hundred adult participants who follow a therapeutic diet will be recruited from the Washington DC area. Participants will be asked to rate their impression on the foods that they were eating in the past two weeks. Fifty participants will be chosen at random and asked to complete the questionnaire a second time, three weeks later, to assess reliability. Ratings will be used to assess the validity and reliability of the Food Acceptability Questionnaire (FAQ).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

189Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be older than 18 years and follow any kind of therapeutic diet.

Exclusion Criteria:

Those who have difficulty eating by themselves will be excluded. No vulnerable subjects will be included.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Men and women following a theraputic diet for at least 1 month

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neal Barnard, MD	Physicians Committee for Responsible Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Physicians Committee for Responsible Medicine		Washington D.C.	District of Columbia	20016	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15129892	Background	Ahlgren SS, Shultz JA, Massey LK, Hicks BC, Wysham C. Development of a preliminary diabetes dietary satisfaction and outcomes measure for patients with type 2 diabetes. Qual Life Res. 2004 May;13(4):819-32. doi: 10.1023/B:QURE.0000021694.59992.a1.
3981480	Background	Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.

ID	Term
D001522	Behavior, Animal
D001519	Behavior