Subsidized Healthy Food Prescription Program
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Complications
- Diabetes Mellitus - Type 2
- Diet, Healthy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Masking Description: Investigators will be blinded to group allocation during data collection.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
It is vital for individuals with type 2 diabetes (T2DM) to adhere to a healthy dietary pattern to maintain optimal blood glucose levels and overall health. However, the increasing costs of healthy foods is a barrier to maintaining healthful dietary patterns, particularly for individuals with T2DM wh...
It is vital for individuals with type 2 diabetes (T2DM) to adhere to a healthy dietary pattern to maintain optimal blood glucose levels and overall health. However, the increasing costs of healthy foods 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. Although the adverse impact of food insecurity on maintaining optimal blood glucose levels is well documented, effective strategies to address food insecurity among individuals with T2DM are lacking. One approach to address this problem is to provide subsidies for individuals to purchase healthy foods through subsidized healthy food prescription programs. These programs may help to reduce food insecurity and improve diet quality, thereby improving blood glucose levels and reducing diabetes complications over time. Using a type 2 hybrid effectiveness-implementation design, we will conduct three concurrent studies (i.e. randomized controlled trial, implementation study, modelling study) to examine the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of a subsidized healthy food prescription program among adults who are experiencing food insecurity and persistent hyperglycemia. The randomized controlled trial will examine the effectiveness of a subsidized healthy food prescription program compared to a healthy food prescription only in improving average blood glucose levels among adults who are experiencing food insecurity and persistent hyperglycemia. Methods: 404 adults who are experiencing food insecurity and persistent hyperglycemia (i.e., hemoglobin A1C 8-12%) from urban and rural primary care clinics will be randomized to a 6 month subsidized healthy food prescription intervention (n=202) or a healthy food prescription comparison group (n=202). The subsidized healthy food prescription program consists of the following two core elements: 1) The one-time healthy food prescription pamphlet is a low literacy resource comprised of a pre-printed healthy food prescription that outlines an evidence-based healthy dietary pattern; 2) The healthy food subsidy provides $1.50/day/household member to purchase healthy foods in participating supermarkets for 6 months. The intervention will be delivered over 6 months to allow sufficient time for dietary changes to be reflected in two A1c cycles. At baseline (0 months) and follow-up (6 months), participants will access a pilot-tested web-based platform to provide responses to sociodemographic and health-related items, and a variety of patient-reported outcomes, including food insecurity. To assess diet quality, dietary intake will be assessed via two 24-hour dietary recalls at each time point using the Automated Self-Administered Dietary Assessment Tool for Canada (ASA24-Canada-2018). Clinical measurements (biochemical and physical measurements) will be obtained to assess blood glucose, blood lipids, BMI, blood pressure, skin carotenoids, and waist circumference.
Tracking Information
- NCT #
- NCT04725630
- Collaborators
- Alberta Innovates Health Solutions
- Alberta Health Services
- Alberta Blue Cross
- Nu Skin
- Investigators
- Principal Investigator: Dana Olstad, PhD University of Calgary