Does Statin Initiation Undermine Dietary Behavior? | NCT00224159

Studies
Does Statin Initiation Undermine Dietary Behavior?

NCT00224159

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Feb 21, 2011Estimated

Enrollment

100

Phase

Not provided

Conditions

All English Speaking Adults From the Manhattan VA Clinic Who Have Recently Received Their First Prescription for a Statin

Interventions

Drug and Dietary behavior

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

Feb 2011

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

Feb 2005

Primary Completion Date

Not provided

Completion Date

Jun 2006

First Submitted Date

Sep 20, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 22, 2005Estimated

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

Feb 18, 2011

Last Update Posted Date

Feb 21, 2011Estimated

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED

Description Module

Brief Summary

The purpose of this research is to improve our understanding of the effects that taking cholesterol reducing pills have on dietary behavior as well as other health related behaviors

Detailed Description

This study explores the impact of initiating statin therapy on subsequent dietary as well as other lifestyle beliefs, attitudes and behaviors.

Specific aims:

To test whether the initiation of statin therapy increases dietary saturated fat intake among statin naive patients.
To determine what role attitudes, beliefs, expectations, motivation, intention and self-efficacy regarding drug or diet therapy may play in observed changes in dietary behavior after starting statin therapy.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
Drug and Dietary behavior	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
How drug or dietary therapy may play a role in dietary behavior.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All English-speaking adults who have recently (within 1 week)received their first prescription for a statin will be eligible.

Exclusion Criteria:

Will include a history of any of the following:

Prior CVD (myocardial infarction, angina, angioplasty, stroke, CABG. or arterial bypass surgery)
Diabetes patients
Psychiatric patients
AIDS patients
Substance abuse patients
Prior cholesterol lowering medication use
Inability to complete the interviews

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All English-speaking adults who have recently (within 1 week)received their first prescription for a statin will be eligible.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sundar Natarajan, MD, MSc	Weill Medical College of Cornell University	Principal Investigator
Devin Mann, MD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The New York Presbyterian Hospital-Weill Medical Center		New York	New York	10021	United States

Condition Browse Module

MeSH Terms

ID	Term
D001519	Behavior

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004364	Pharmaceutical Preparations

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided