NCT03243136

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,739

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

12.3 years

First QC Date

August 4, 2017

Last Update Submit

August 7, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Type 2 diabetes

    Incident type 2 diabetes

    2004-2016

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Officials

  • Christopher Tait, PhD(c)

    University of Toronto - Dalla Lana School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 8, 2017

Study Start

January 1, 2004

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

August 8, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share