<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03243136</url>
  </required_header>
  <id_info>
    <org_study_id>PROTOCOL REFERENCE # 32143</org_study_id>
    <nct_id>NCT03243136</nct_id>
  </id_info>
  <brief_title>The Association Between Food Insecurity and Incident Type 2 Diabetes in Canada: A Population-based Cohort Study</brief_title>
  <official_title>The Association Between Food Insecurity and Incident Type 2 Diabetes in Canada: A Population-based Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christopher Tait</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ontario Agency for Health Protection and Promotion</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pervasive and persistent finding is the health disadvantage experienced by those in food&#xD;
      insecure households. While clear associations have been identified between food insecurity&#xD;
      and diabetes risk factors, less is known about the relationship between food insecurity and&#xD;
      incident type 2 diabetes.&#xD;
&#xD;
      The objective of this study is to investigate the association between household food&#xD;
      insecurity and the future development of type 2 diabetes.&#xD;
&#xD;
      The investigators used data from Ontario adult respondents to the 2004 Canadian Community&#xD;
      Health Survey, linked to health administrative data (n = 4,739). Food insecurity was assessed&#xD;
      with the Household Food Security Survey Module and incident type 2 diabetes cases were&#xD;
      identified by the Ontario Diabetes Database. Multivariable adjusted Cox proportional hazards&#xD;
      models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for type&#xD;
      2 diabetes as a function of food insecurity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Globally, there are over 200 million people living with type 2 diabetes. Aging populations,&#xD;
      steadily increasing obesity rates, increases in sedentary behaviours, and decreases in&#xD;
      diabetes-related mortality signal that the global prevalence of type 2 diabetes will continue&#xD;
      to grow.&#xD;
&#xD;
      In Canada, type 2 diabetes is one of the most prevalent chronic conditions and is the 7th&#xD;
      leading cause of mortality. Over the last decade, the prevalence of type 2 diabetes in Canada&#xD;
      has increased by 72%, with 11 million Canadians currently living with diabetes or&#xD;
      pre-diabetes. This number is expected to rise to 13.9 million (33% of Canadians) by 2026.&#xD;
&#xD;
      Much of the body of literature concerning type 2 diabetes focuses on management and control.&#xD;
      Research that is geared towards prevention focuses heavily on the modification of individual&#xD;
      risk behaviours, while less attention is given to the broader social determinants of&#xD;
      increased type 2 diabetes risk.&#xD;
&#xD;
      Household food security is a broad measure of socioeconomic status that is not traditionally&#xD;
      included in health research. Household food insecurity is experienced when there is&#xD;
      uncertainty regarding, or disruption in, food intake or eating patterns by at least one&#xD;
      member of a household due to financial constraints, resulting in inadequate or insecure&#xD;
      access to food.&#xD;
&#xD;
      Food insecurity has been identified as a significant social and health problem in Canada . It&#xD;
      was first measured in 2004, where it was estimated that 9.2% of Canadian households were food&#xD;
      insecure. The most recent estimate from 2014 indicates that this number has risen to 12%,&#xD;
      representing 3.2 million Canadians.&#xD;
&#xD;
      While there exists the perception that food insecurity leads to caloric restriction, food&#xD;
      insecurity has been associated with lower nutrient intakes and consumption of a less healthy&#xD;
      diet compared to those who are food secure. Prior evidence from cross-sectional studies has&#xD;
      demonstrated that there is an association between food insecurity and chronic disease risk&#xD;
      including hypertension, cardiovascular disease, and type 2 diabetes.&#xD;
&#xD;
      Though clear associations have been identified between food insecurity and diabetes risk&#xD;
      factors such as dietary consumption, weight gain, and obesity, less is known about the direct&#xD;
      relationship between food insecurity and incident type 2 diabetes. Moreover, limited studies&#xD;
      have investigated this association longitudinally in a population-based sample.&#xD;
&#xD;
      Prospective, longitudinal assessment is critical as cross-sectional studies lack the ability&#xD;
      to infer the direction of the relationship between food insecurity and type 2 diabetes. For&#xD;
      example, the 'health selection' hypothesis has been studied, positing that a decline in&#xD;
      health status may precede and ultimately cause downward social mobility and a decrease in&#xD;
      income leading to food insecurity. Consequently, this theory presents evidence for reverse&#xD;
      causation, by which poor health may precede financial difficulties, especially in cases where&#xD;
      early age of diagnosis, and thus longer duration of disease, might predispose individuals to&#xD;
      being in a food insecure household.&#xD;
&#xD;
      Current estimates of the future health consequences associated with food insecurity are&#xD;
      needed to inform health decision-makers of potential areas for upstream intervention to&#xD;
      alleviate the burden type 2 diabetes places on the Canadian healthcare system. Data linkages&#xD;
      provide a novel opportunity to study this relationship in a prospective, population-based&#xD;
      sample. Accordingly, the objectives of this study are to estimate the risk of type 2 diabetes&#xD;
      as a function of food insecurity in the Canadian population, and to investigate the extent to&#xD;
      which this association may be mediated by obesity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2004</start_date>
  <completion_date type="Actual">March 31, 2016</completion_date>
  <primary_completion_date type="Actual">March 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Type 2 diabetes</measure>
    <time_frame>2004-2016</time_frame>
    <description>Incident type 2 diabetes</description>
  </primary_outcome>
  <enrollment type="Actual">4739</enrollment>
  <condition>Type2 Diabetes</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exposure of interest is food insecurity</intervention_name>
    <description>Households were considered food insecure if any of the following conditions were met in the past 12 months: 1) a member of the household worried that there would not be enough food to eat because of a lack of money, 2) a member's food intake was reduced as a result of there not being enough food to eat, or 3) the desired variety or quality of foods was not eaten because of a lack of money. This exposure variable was operationalized as a binary variable with levels of food secure vs. food insecure.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators used data from Ontario adult respondents to Cycle 2.2 of Canadian&#xD;
        Community Health Survey conducted in 2004, deterministically linked to the Ontario Diabetes&#xD;
        Database. The Canadian Community Health Survey is a cross-sectional survey administered by&#xD;
        Statistics Canada that uses a multi-stage, stratified, clustered probability sample that is&#xD;
        representative of 98% of the Canadian population. Those who are full-time members of the&#xD;
        Canadian Forces, reside on First Nations Reserves or Crown Lands, are institutionalized,&#xD;
        and who reside in certain remote areas reflect the 2% of the population not captured by the&#xD;
        survey. Detailed descriptions of the survey methodology have been published elsewhere.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        The investigators restricted the analyses to individuals ≥ 18 years of age at baseline who&#xD;
        were successfully linked to the Ontario Diabetes Database (n = 5,539). The investigators&#xD;
        further excluded pregnant women from the sample to increase the accuracy of body weight&#xD;
        measurements (n = 36), prevalent cases of diabetes before respondents' 2004 Canadian&#xD;
        Community Health Survey interview date (n = 636), underweight individuals (n = 112), and&#xD;
        those who had missing information on food security status (n = 16). After these exclusions,&#xD;
        the analytic cohort consists of 4,739 individuals, 2,050 men and 2,689 women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Tait, PhD(c)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto - Dalla Lana School of Public Health</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Christopher Tait</investigator_full_name>
    <investigator_title>PhD Candidate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03243136
org study id: PROTOCOL REFERENCE # 32143
nct id: NCT03243136
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Type 2 diabetes
time frame: 2004-2016
description: Incident type 2 diabetes
intervention type: Other
intervention name: Exposure of interest is food insecurity
description: Households were considered food insecure if any of the following conditions were met in the past 12 months: 1) a member of the household worried that there would not be enough food to eat because of a lack of money, 2) a member's food intake was reduced as a result of there not being enough food to eat, or 3) the desired variety or quality of foods was not eaten because of a lack of money. This exposure variable was operationalized as a binary variable with levels of food secure vs. food insecure.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher Tait, PhD(c)
role: Principal Investigator
affiliation: University of Toronto - Dalla Lana School of Public Health
responsible party type: Sponsor-Investigator
investigator affiliation: University of Toronto
investigator full name: Christopher Tait
investigator title: PhD Candidate
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No