NCT04725630Completed
Healthy Food Prescription Incentive Program
A Healthy Food Prescription Incentive Program for Adults With Type 2 Diabetes Who Are Experiencing Food Insecurity
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 597 (actual)
- First submitted
- 19 Jan 2021
- Start date
- 29 May 2021
- Primary completion date
- 28 Feb 2024
- Lead sponsor
- University of Calgary
- Diseases
- Type 2 diabetes
- NCT number
- NCT04725630
What you commit to
- Study type: Interventional
- Participants enrolled: 597
- From 29 May 2021 to the primary completion date, 28 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A household member is currently or has previously participated in this trial
Other illness
- Diagnosis of eating disorder(s) (e.g., anorexia nervosa, bulimia)
Other
- A1c \<6.5% or \> 12% given the recommendation for anti-hyperglycemic treatment escalation for those with A1c\>12%
- Reside in a facility that provides meals (e.g., shelter, long-term care, prison)
- Exhibit signs/symptoms of metabolic decompensation (weight loss, polyuria, polydipsia)
- Have experienced diabetic ketoacidosis or a hyperglycemic hyperosmolar emergency in the past year
- Experienced a hypoglycemic event in the past 3 months
- Are trying to conceive, pregnant and/or breastfeeding
- Are currently participating in other clinical trials
- Unwilling/unable to shop in study-affiliated supermarkets for the next 12 months
- Plan to leave for Canada for more than 2 weeks in the next 12 months
- Unable to complete data collection at follow-up (e.g., due to moving)
Who the study is looking for
- Adults (18-85 years) with type 2 diabetes (or diabetes of unknown etiology)
- Persistent hyperglycemia (i.e. hemoglobin A1C 6.5-12%)
- Are currently experiencing food insecurity and/or report that it is difficult/very difficult to make ends meet
- Can communicate in English or have someone to translate
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Primary Care Clinics Coordinator of this site? Confirm its status | Various Cities | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.