Cardiovascular DiseasesNCT03243253
The Association of Fast Food Densities With Mortality From Cardiovascular Disease
An observational study of Cardiovascular Diseases, run by Chinese Academy of Sciences.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- all the data collection have done by CDC.
- How many people
- 17,000,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 1 Feb 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- age>35 years
Who cannot join
- None
- -
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- all the data collection have done by CDC.
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all the data collection have done by CDC.Other
In this study there was no intervention, just simple data collection via CDC.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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).
Measured: 2011 to 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Jan 2011
- Primary completion1 Jan 2012
- Study completion1 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 17,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, John Speakman, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243253
- Sponsor's protocol ID
- CDC
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all of our data are in public available, www.CDC.org
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.
PubMed 28566310Speakman 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.
PubMed 27477955Mazidi 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.
PubMed 29802148
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Fast Food and Full Service Restaurant Densities With Mortality From Cardiovascular Disease and Stroke, and the Prevalence of Diabetes
- ClinicalTrials.gov ID
- NCT03243253
- Acronym / sponsor ID
- CDC
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,000,000 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2012 (actual)
- Study completion
- 1 Feb 2013 (actual)
- First posted
- 8 Aug 2017 (actual)
- 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.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- age>35 years
Key exclusion criteria (2 listed)
- None
- -
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 |
|---|---|---|
| all the data collection have done by CDC.In this study there was no intervention, just simple data collection via CDC. | Other | – |
Primary outcome
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).
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 8 Aug 2017.
- Results publication: PubMed 28566310Mazidi 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.
- Results publication: PubMed 27477955Speakman 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.
- Derived from this study: PubMed 29802148Mazidi 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.
- CDC websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all of our data are in public available, www.CDC.org
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Chinese Academy of Sciences.
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 2 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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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). 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 NCT03243253, which also lists 3 linked publications.
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 8 Aug 2017.