All English Speaking Adults From the Manhattan VA Clinic Who Have Recently Received Their First Prescription for a StatinNCT00224159

Does Statin Initiation Undermine Dietary Behavior?

An observational study of All English Speaking Adults From the Manhattan VA Clinic Who Have Recently Received Their First Prescription for a Statin, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: All English Speaking Adults From the Manhattan VA Clinic Who Have Recently Received Their First Prescription for a Statin
What is being tested?: Drug and Dietary behavior
Type of treatment: Lifestyle or therapy programme
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Feb 2005to Jun 2006
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The New York Presbyterian Hospital-Weill Medical Center
New York, New York, 10021

Other trials in United States

About this study

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

Read the 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.

Conditions: All English Speaking Adults From the Manhattan VA Clinic Who Have Recently Received Their First Prescription for a Statin
Being tested: Drug and Dietary behavior
Keywords: Statin therapy, Dietary behavior, Attitudes and beliefs, Self efficacy
Medical subject headings: Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug and Dietary behaviorBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

How drug or dietary therapy may play a role in dietary behavior.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005Jun 2006

First posted22 Sep 2005 (estimated)
Study startFeb 2005
Study completionJun 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for All English Speaking Adults From the Manhattan VA Clinic Who Have Recently Received Their First Prescription for a StatinStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Enrolment: 100 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00224159
Sponsor's protocol ID: 00710
Status last verified: Feb 2011
First submitted: 20 Sep 2005
Last updated: 21 Feb 2011
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Statin Initiation Undermine Dietary Behavior?
ClinicalTrials.gov ID: NCT00224159
Acronym / sponsor ID: 00710
Conditions: All English Speaking Adults From the Manhattan VA Clinic Who Have Recently Received Their First Prescription for a Statin
Keywords: Statin therapy, Dietary behavior, Attitudes and beliefs, Self efficacy
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: Agency for Healthcare Research and Quality (AHRQ)
Study start: Feb 2005
Study completion: Jun 2006
First posted: 22 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All English-speaking adults who have recently (within 1 week)received their first prescription for a statin will be eligible.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

Prior CVD (myocardial infarction, angina, angioplasty, stroke, CABG. or arterial bypass surgery)
Diabetes patients
Psychiatric patients
AIDS patients
Substance abuse patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug and Dietary behavior	Behavioural	–

Primary outcome

How drug or dietary therapy may play a role in dietary behavior.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sundar Natarajan, MD, MSc principal investigator

Weill Medical College of Cornell University

Devin Mann, MD principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

How drug or dietary therapy may play a role in dietary behavior.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00224159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2011.