Trial Summary
What is the purpose of this trial?
It is important for individuals with type 2 diabetes (T2DM) to adhere to a healthy dietary pattern to maintain optimal blood glucose levels and overall health. The increasing costs of healthy foods, however, is a barrier to maintaining healthful dietary patterns, particularly for individuals with T2DM who are experiencing food insecurity (i.e., inadequate or insecure access to food due to financial constraints). Lower diet quality may result in difficulties maintaining optimal blood glucose levels, leading to higher rates of diabetes complications, and increased acute care usage and costs. Effective strategies to address this issue are lacking despite the well-known impact of food insecurity on maintaining optimal blood glucose levels. One way to address this problem is to provide incentives to purchase healthy foods through healthy food prescription programs. These programs may help to reduce food insecurity and improve diet quality, thereby improving blood glucose control and reducing diabetes complications over time. This study will investigate the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of a healthy food prescription incentive program among adults who are experiencing food insecurity and persistent hyperglycemia through three concurrent studies; a randomized controlled trial, an implementation study, and a modelling study. The randomized controlled trial will examine the effectiveness of a healthy food prescription incentive program compared to a healthy food prescription alone in reducing blood glucose levels among adults who are experiencing food insecurity and persistent hyperglycemia.
Research Team
Dana Olstad, PhD
Principal Investigator
University of Calgary
Eligibility Criteria
This trial is for adults aged 18-85 with type 2 diabetes and persistent high blood sugar, who struggle to afford healthy food. Participants must speak English or have a translator, not plan extensive travel outside Canada, be able to shop at certain supermarkets, and not live in meal-providing facilities.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Healthy food incentive (Behavioral Intervention)
- Healthy food prescription (Behavioral Intervention)
- Healthy food subsidy (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Dr. Shweta Patel
University of Calgary
Chief Medical Officer since 2020
MD from the University of Baroda Medical College, India
Dr. Edward McCauley
University of Calgary
President and Vice-Chancellor since 2018
PhD in Ecology and Evolutionary Biology from the University of California, Santa Barbara
Nu Skin Enterprises
Industry Sponsor
Nu Skin
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Dr. Paul C. Hébert
Canadian Institutes of Health Research (CIHR)
Chief Executive Officer
MD, University of Ottawa
Dr. Paul C. Hébert
Canadian Institutes of Health Research (CIHR)
Chief Medical Officer
MD, University of Ottawa
Alberta Blue Cross
Collaborator
Alberta Innovates Health Solutions
Collaborator
Alberta Health services
Collaborator
Dr. Verna Yiu
Alberta Health services
Chief Medical Officer
MD
Andre Tremblay
Alberta Health services
Chief Executive Officer
Bachelor's degree in a relevant field