← Back to all trials
Completed
NCT04725630
Healthy Food Prescription Incentive Program
Conditions: Diet, Healthy, Diabetes Mellitus, Type 2, Diabetes Complications
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 597
Sponsor: University of Calgary
Location: Primary Care Clinics Various Cities Alberta
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.
Eligibility Criteria
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 \ 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)
Source: ClinicalTrials.gov (NCT04725630). StuddyBuddy aggregates publicly available trial information.