The Association Between Food Insecurity and Incident Type 2 Diabetes in Canada: A Population-based Cohort Study

August 7, 2017 updated by: Christopher Tait

A pervasive and persistent finding is the health disadvantage experienced by those in food insecure households. While clear associations have been identified between food insecurity and diabetes risk factors, less is known about the relationship between food insecurity and incident type 2 diabetes.

The objective of this study is to investigate the association between household food insecurity and the future development of type 2 diabetes.

The investigators used data from Ontario adult respondents to the 2004 Canadian Community Health Survey, linked to health administrative data (n = 4,739). Food insecurity was assessed with the Household Food Security Survey Module and incident type 2 diabetes cases were identified by the Ontario Diabetes Database. Multivariable adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for type 2 diabetes as a function of food insecurity.

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

Globally, there are over 200 million people living with type 2 diabetes. Aging populations, steadily increasing obesity rates, increases in sedentary behaviours, and decreases in diabetes-related mortality signal that the global prevalence of type 2 diabetes will continue to grow.

In Canada, type 2 diabetes is one of the most prevalent chronic conditions and is the 7th leading cause of mortality. Over the last decade, the prevalence of type 2 diabetes in Canada has increased by 72%, with 11 million Canadians currently living with diabetes or pre-diabetes. This number is expected to rise to 13.9 million (33% of Canadians) by 2026.

Much of the body of literature concerning type 2 diabetes focuses on management and control. Research that is geared towards prevention focuses heavily on the modification of individual risk behaviours, while less attention is given to the broader social determinants of increased type 2 diabetes risk.

Household food security is a broad measure of socioeconomic status that is not traditionally included in health research. Household food insecurity is experienced when there is uncertainty regarding, or disruption in, food intake or eating patterns by at least one member of a household due to financial constraints, resulting in inadequate or insecure access to food.

Food insecurity has been identified as a significant social and health problem in Canada . It was first measured in 2004, where it was estimated that 9.2% of Canadian households were food insecure. The most recent estimate from 2014 indicates that this number has risen to 12%, representing 3.2 million Canadians.

While there exists the perception that food insecurity leads to caloric restriction, food insecurity has been associated with lower nutrient intakes and consumption of a less healthy diet compared to those who are food secure. Prior evidence from cross-sectional studies has demonstrated that there is an association between food insecurity and chronic disease risk including hypertension, cardiovascular disease, and type 2 diabetes.

Though clear associations have been identified between food insecurity and diabetes risk factors such as dietary consumption, weight gain, and obesity, less is known about the direct relationship between food insecurity and incident type 2 diabetes. Moreover, limited studies have investigated this association longitudinally in a population-based sample.

Prospective, longitudinal assessment is critical as cross-sectional studies lack the ability to infer the direction of the relationship between food insecurity and type 2 diabetes. For example, the 'health selection' hypothesis has been studied, positing that a decline in health status may precede and ultimately cause downward social mobility and a decrease in income leading to food insecurity. Consequently, this theory presents evidence for reverse causation, by which poor health may precede financial difficulties, especially in cases where early age of diagnosis, and thus longer duration of disease, might predispose individuals to being in a food insecure household.

Current estimates of the future health consequences associated with food insecurity are needed to inform health decision-makers of potential areas for upstream intervention to alleviate the burden type 2 diabetes places on the Canadian healthcare system. Data linkages provide a novel opportunity to study this relationship in a prospective, population-based sample. Accordingly, the objectives of this study are to estimate the risk of type 2 diabetes as a function of food insecurity in the Canadian population, and to investigate the extent to which this association may be mediated by obesity.

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.
4739

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The investigators used data from Ontario adult respondents to Cycle 2.2 of Canadian Community Health Survey conducted in 2004, deterministically linked to the Ontario Diabetes Database. The Canadian Community Health Survey is a cross-sectional survey administered by Statistics Canada that uses a multi-stage, stratified, clustered probability sample that is representative of 98% of the Canadian population. Those who are full-time members of the Canadian Forces, reside on First Nations Reserves or Crown Lands, are institutionalized, and who reside in certain remote areas reflect the 2% of the population not captured by the survey. Detailed descriptions of the survey methodology have been published elsewhere.

Description

The investigators restricted the analyses to individuals ≥ 18 years of age at baseline who were successfully linked to the Ontario Diabetes Database (n = 5,539). The investigators further excluded pregnant women from the sample to increase the accuracy of body weight measurements (n = 36), prevalent cases of diabetes before respondents' 2004 Canadian Community Health Survey interview date (n = 636), underweight individuals (n = 112), and those who had missing information on food security status (n = 16). After these exclusions, the analytic cohort consists of 4,739 individuals, 2,050 men and 2,689 women.

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
Type 2 diabetes
Time Frame: 2004-2016
Incident type 2 diabetes
2004-2016

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.
Christopher Tait

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ontario Agency for Health Protection and Promotion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Tait, PhD(c), University of Toronto - Dalla Lana School of Public Health

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, 2004

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.
March 31, 2016

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.
March 31, 2016

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 4, 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 7, 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 7, 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.
  • PROTOCOL REFERENCE # 32143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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