Subsidized Healthy Food Prescription Program

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    404
  • sponsor
    University of Calgary
Updated on 17 October 2021
hyperglycemia
hemoglobin a1c

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 subsidies to purchase healthy foods through a subsidized healthy food prescription program. 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 subsidized healthy food prescription 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 subsidized healthy food prescription program compared to a healthy food prescription only in reducing blood glucose levels among adults who are experiencing food insecurity and persistent hyperglycemia.

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 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, quantified via hemoglobin A1C, among adults who are experiencing food insecurity and persistent hyperglycemia. Secondary outcomes include blood glucose levels quantified via fructosamine, the proportion of patients with elevated hemoglobin A1C (i.e. 8.5%), diet quality and skin carotenoid levels, intermediate clinical outcomes (blood lipids, blood pressure, BMI, waist circumference, need for anti-hyperglycemic medication/insulin) and patient-reported outcomes (psychosocial well-being, self-rated health, diabetes self-efficacy, diabetes self-management, diabetes distress, diabetes competing demands, perceived financial barriers to chronic disease care, hypoglycemic episodes, household food insecurity).

Methods: 404 adults who are experiencing food insecurity and persistent hyperglycemia (i.e., hemoglobin A1C 7-12%) 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. Need for anti-hyperglycemic medication/insulin will be quantified via administrative health records.

Details
Condition NIDDM, Diabetes Mellitus, diabetic complication, type 2 diabetes mellitus, diabetic complications, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2, Diet, Healthy, Diet, Healthy, Diet, Healthy, Diet, Healthy, Diet, Healthy
Treatment Healthy food subsidy, Healthy food prescription
Clinical Study IdentifierNCT04725630
SponsorUniversity of Calgary
Last Modified on17 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults (18-85 years) with type 2 diabetes (or diabetes of unknown etiology)
Persistent hyperglycemia (i.e. hemoglobin A1C 7-12%)
Are currently experiencing food insecurity
Can communicate in English or have someone to translate

Exclusion Criteria

A1c <7% 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)
Are functionally dependent
Limited life expectancy (< 2 years), per referring provider's expectation
Have experienced diabetic ketoacidosis or a hyperglycemic hyperosmolar emergency in the past year
Have a history of recurrent severe hypoglycemia or hypoglycemic unawareness
Diagnosis of dementia (e.g., Alzheimer's disease, vascular dementia)
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 6 months
Plan to leave for Canada for more than 2 weeks in the next 6 months
Unable to complete data collection at 6 months (e.g., due to moving)
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