Healthy Food Prescription Incentive Program (NCT04725630) | Clinical Trial Compass
CompletedNot Applicable
Healthy Food Prescription Incentive Program
Canada597 participantsStarted 2021-05-29
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* Diagnosis of eating disorder(s) (e.g., anorexia nervosa, bulimia)
* 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
* A household member is currently or has previously participated in this trial
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood glucose levels via hemoglobin A1C
Timeframe: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)