- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03243253
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
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:
- 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
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
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
- Mazidi M, Speakman JR. Higher densities of fast-food and full-service restaurants are not associated with obesity prevalence. Am J Clin Nutr. 2017 Aug;106(2):603-613. doi: 10.3945/ajcn.116.151407. Epub 2017 May 31.
- Speakman JR, Heidari-Bakavoli S. Type 2 diabetes, but not obesity, prevalence is positively associated with ambient temperature. Sci Rep. 2016 Aug 1;6:30409. doi: 10.1038/srep30409.
- Mazidi M, Speakman JR. Association of Fast-Food and Full-Service Restaurant Densities With Mortality From Cardiovascular Disease and Stroke, and the Prevalence of Diabetes Mellitus. J Am Heart Assoc. 2018 May 25;7(11):e007651. doi: 10.1161/JAHA.117.007651.
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)
January 1, 2011
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
February 1, 2013
Study Registration Dates
First Submitted
August 2, 2017
First Submitted That Met QC Criteria
August 3, 2017
First Posted (ACTUAL)
August 8, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 8, 2017
Last Update Submitted That Met QC Criteria
August 3, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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