Healthy Food Prescription Incentive Program

NCT ID: NCT04725630

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 597 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-29
• Study Completion Date: 2025-03-07

Brief 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.

Detailed 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 incentives for individuals 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 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 healthy food prescription incentive program among adults who are experiencing food insecurity and persistent hyperglycemia. The randomized controlled trial will examine the effectiveness of a healthy food prescription incentive program compared to a healthy food prescription alone in improving 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: 594 adults who are experiencing food insecurity and persistent hyperglycemia (i.e., hemoglobin A1C 6.5-12%) from urban and rural primary care clinics will be randomized to a 12 month healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297).

The healthy food prescription incentive 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 incentive provides a weekly incentive of $10.50/household member to purchase healthy foods in participating supermarkets for 12 months. The intervention will be delivered over 12 months to allow sufficient time for dietary changes to be reflected in several A1c cycles.

At baseline (0 months) and follow-up (12 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 household 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. At 6 months and 18 months participants will have their blood glucose levels measured. They will also report their dietary intake via two 24-hour dietary recalls and their household food insecurity status.

Conditions

Diet, Healthy; Diabetes Mellitus, Type 2; Diabetes Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Subsidized Healthy Food Prescription Incentive

Participants will receive a one-time healthy food prescription pamphlet from their healthcare provider and a weekly incentive of $10.50/household member to purchase healthy foods in supermarkets for 12 months. The list of incentive-eligible foods includes whole, minimally processed foods with little to no added fat, sugar or salt from all food groups.

Group Type: EXPERIMENTAL

Healthy food incentive

Intervention Type: BEHAVIORAL

$10.50/week/household member for 12 months to purchase healthy foods in participating supermarkets.

Healthy food prescription

Intervention Type: BEHAVIORAL

A one-time healthy food prescription pamphlet

Healthy Food Prescription Comparison

Participants will receive a one-time healthy food prescription pamphlet from their healthcare provider. The pamphlet closely mimics current standard of care for patients with diabetes in Alberta (i.e., nutrition counselling).

Group Type: ACTIVE_COMPARATOR

Healthy food prescription

Intervention Type: BEHAVIORAL

A one-time healthy food prescription pamphlet

Interventions

Healthy food incentive

$10.50/week/household member for 12 months to purchase healthy foods in participating supermarkets.

Intervention Type: BEHAVIORAL

Healthy food prescription

A one-time healthy food prescription pamphlet

Intervention Type: BEHAVIORAL

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 <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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Innovates Health Solutions

OTHER

Sponsor Role: collaborator

Alberta Health services

OTHER

Sponsor Role: collaborator

Alberta Blue Cross

UNKNOWN

Sponsor Role: collaborator

Nu Skin Enterprises

INDUSTRY

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dana Lee Olstad

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dana Olstad, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Primary Care Clinics

Multiple Locations, Alberta, Canada

Countries

Canada

References

Olstad DL, Beall R, Spackman E, Dunn S, Lipscombe LL, Williams K, Oster R, Scott S, Zimmermann GL, McBrien KA, Steer KJD, Chan CB, Tyminski S, Berkowitz S, Edwards AL, Saunders-Smith T, Tariq S, Popeski N, White L, Williamson T, L'Abbe M, Raine KD, Nejatinamini S, Naser A, Basualdo-Hammond C, Norris C, O'Connell P, Seidel J, Lewanczuk R, Cabaj J, Campbell DJT. Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies. BMJ Open. 2022 Feb 15;12(2):e050006. doi: 10.1136/bmjopen-2021-050006.

Reference Type: DERIVED

PMID: 35168964 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

REB20-0543

Identifier Type: -

Identifier Source: org_study_id