The Association of Fast Food Densities With Mortality From Cardiovascular Disease

August 3, 2017 updated by: John Speakman, Chinese Academy of Sciences

The Association of Fast Food and Full Service Restaurant Densities With Mortality From Cardiovascular Disease and Stroke, and the Prevalence of Diabetes

In this cross sectional study, county level data for CVD and stroke mortality, and prevalence of T2D, were combined with per capita densities of FFR and FSR and analysed using multiple and simple linear regression. Mortality and diabetes prevalence were corrected for poverty, ethnicity, education, physical inactivity and smoking to reduce confounding effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

the investigators used data on mortality rate (per 100,000 individuals) for CVD and stroke (between 2011 and 2013, age>35years) from the publicly available Centers for disease prevention and control (CDC) web site (www.cdc.gov). CVD mortality was defined as the number of deaths per 100,000 person-years due to circulatory causes (International Statistical Classification of Diseases, Tenth Revision, codes I00-I99). Detailed information on preparation, definition, download and sorting of data on prevalence of T2D (age-adjusted), poverty and ethnicity have been explained elsewhere. In brief, county level data on the prevalence of T2D were downloaded from the USA CDC web site (www.cdc.gov). Data on T2D was estimated using data from the CDC Behavioural Risk Factor Surveillance System (BRFSS) which is a monthly state based telephone survey of a nationally representative sample of adults aged >20 years old. In 2012, the year for which these data were downloaded, the survey included landline telephones only and hence excluded individuals living in care homes or those without a landline telephone. More than 400,000 individuals are contacted annually to take part in the survey which has been running since 1984. Individuals are judged to have diabetes if they respond 'yes;' to the question "Has a doctor ever told participants that you have diabetes?", excluding females who indicate in a follow-up question that they only had diabetes during pregnancy. Previous work indicates that self-report of a physician's prior diagnosis of diabetes is highly reliable compared to medical records. This question does not separate those with type 1 and T2D. In the adult population of the USA more than 96% of diabetes is type 2, the investigators therefore called the estimated prevalence that of T2D. Given the magnitudes of the trends described here they cannot be attributed to differences in prevalence of the type 1 diabetes. Data on rate of mortality (per 100,000 individuals) from CVD and stroke (between 2011 and 2013, age>35years) were also downloaded from CDC web site (www.cdc.gov, National Vital Statistics System and National Centre for Health Statistics). A previous variogram analysis has established that counties are an appropriate spatial level at which to explore the associations of factors to T2D prevalence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17000000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We used data on mortality rate (per 100,000 individuals) for CVD and stroke (between 2011 and 2013, age>35years) from the publicly available Centers for disease prevention and control (CDC) web site (www.cdc.gov).

Description

Inclusion Criteria:

  1. age>35 years

Exclusion Criteria:

None

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
association between densities of fast food (FFR) and full service restaurants (FSR) with mortality from CVD and stroke, and the prevalence of type 2 diabetes (T2D).
Time Frame: 2011 to 2013
association between densities of fast food (FFR) and full service restaurants (FSR) with mortality from CVD and stroke, and the prevalence of type 2 diabetes (T2D).
2011 to 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDC (CDC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all of our data are in public available, www.CDC.org

IPD Sharing Time Frame

2011 to 2013

IPD Sharing Access Criteria

there is nor criteria for the sharing these data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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