Diet, HealthyNCT04725630
Healthy Food Prescription Incentive Program
A study testing Healthy food incentive and Healthy food prescription in people with Diet, Healthy and Diabetes Mellitus, Type 2, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diet, Healthy, Diabetes Mellitus, Type 2, Diabetes Complications
- What is being tested?
- Healthy food incentive and Healthy food prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2021to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Healthy Food Prescription Incentive Program for Adults With Type 2 Diabetes Who Are Experiencing Food Insecurity
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.
Read more
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.
Read the 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.
- Being tested
- Healthy food incentive, Healthy food prescription
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy food incentiveBehavioural
$10.50/week/household member for 12 months to purchase healthy foods in participating supermarkets.
Healthy food prescriptionBehavioural
A one-time healthy food prescription pamphlet
| Study group | Role | What they receive |
|---|---|---|
| Subsidized Healthy Food Prescription Incentive | Experimental | 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. Receives: Behavioral: Healthy food incentive; Behavioral: Healthy food prescription |
| Healthy Food Prescription Comparison | Active comparator | 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). Receives: Behavioral: Healthy food prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose levels via hemoglobin A1C
Difference between intervention and comparison groups in blood glucose levels measured by hemoglobin A1C
Measured: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Secondary outcomes (20)
Blood glucose levels via elevated hemoglobin A1C
Difference between intervention and comparison groups in proportion of patients with elevated hemoglobin A1C (>/=8.5%)
Measured: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Blood glucose levels via fructosamine
Difference between intervention and comparison groups in blood glucose levels via fructosamine
Measured: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Overall diet quality by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019
Difference between intervention and comparison groups in mean diet quality by Healthy Eating Index-2015 scores and by Healthy Eating Food Index-2019 scores
Measured: Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months)
Diet quality sub-scores by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019
Difference between intervention and comparison groups in diet quality component scores by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019
Measured: Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months)
Fruit and vegetable intake via skin carotenoids
Difference between intervention and comparison groups in skin carotenoids
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Blood Lipids
Difference between intervention and comparison groups in blood lipids including total-, HDL- and LDL-cholesterol, triglycerides, apolipoprotein B
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Blood Pressure
Difference between intervention and comparison groups in both systolic and diastolic blood pressure
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Body Mass Index
Difference between intervention and comparison groups in Body Mass Index
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Waist Circumference
Difference between intervention and comparison groups in waist circumference
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Anti-hyperglycemic Medication/Insulin
Difference between intervention and comparison groups in need for anti-hyperglycemic medication and/or insulin.
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
World Health Organization-5 Well-Being Scale scores
Difference between intervention and comparison groups in World Health Organization Well-Being Scale scores. The World Health Organization Well-Being scale will be used to assess experiences of well-being in the last 2 weeks with scores ranging from 0 (worst possible quality of life) to 25 (best imaginable quality of life).
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Stanford Diabetes Self-efficacy Scale scores
Difference between intervention and comparison groups in Stanford Diabetes Self-efficacy Scale scores. The Stanford Diabetes Self-efficacy Scale will be used to assess confidence in completing activities related to diabetes. Scores range from 8 (not confident at all) to 80 (totally confident).
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Diabetes Self-Management Questionnaire scores
Difference between intervention and comparison groups in ability to self manage diabetes- related activities. The Diabetes Self-Management Questionnaire will be used to assess effective self-care behaviour, with a score of 0 indicating least effective self-care behaviour and 10 indicating most effective self-care.
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Problem Areas in Diabetes Scale scores
Difference between intervention and comparison groups in Diabetes Scale scores. The Problem Areas in Diabetes Scale will assess emotional distress related to diabetes. Scores can range from 0-100, with scores above 40 indicating higher levels of emotional burnout and scores below 10 indicating denial when combined with poor glycemic control.
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
EQ-5D-5L scores
Difference between intervention and comparison groups in self-reported overall health. The EQ-5D-5L is a 5-item tool that will be used to assess health factors such as mobility, self care, usual activities, pain, anxiety. Level 1 scores indicate "no problems", levels 2-4 scores indicate more frequent problems, level 5 indicates extreme impairments.
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Hypoglycemic Episodes
Difference between intervention and comparison groups in frequency of hypoglycemic episodes. Frequency of hypoglycemic episodes is measured using a single question ("In the past year, how many times have you had a severe low blood sugar reaction, such as passing out or needing help to treat the reaction?"). Categorical responses include 0, 1-3, 4-6, 7-11, 12 or more. Severe hypoglycemia is indicated at 4 or more times.
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Barriers to Care for People with Chronic Health Conditions scores
Difference between intervention and comparison groups in barriers to care. The Barriers to Care for People with Chronic Health Conditions - Economic Barriers to Care scale and Insurance scale will assess economic related barriers in accessing care, which includes services, equipment, and/or medication. Responses of "always", "often", or "sometimes" indicate economic barriers are present.
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Health Canada's Household Food Security Survey Module scores
Difference between intervention and comparison groups in experiences of household food insecurity. Health Canada's 18-item Household Food Security Survey Module will be used to assess experiences of marginal (1 affirmative response), moderate (2-5 affirmative responses) and severe (≥ 6 affirmative responses) household food insecurity in the past 6 months.
Measured: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Diabetes Competing Demands scores
Difference between intervention and comparison groups in Diabetes Competing Demands scores. The Diabetes Competing Demands 2-item scale will be used to assess the frequency of trade-offs between food, medicine, and diabetes supplies. A response of "often" or "sometimes" to either question indicates trade-offs have occurred.
Measured: Assessed at Baseline (0 months) and Follow-up (12 months)
Dose-response analyses
Dose-response analysis will examine whether outcomes depended on the value of healthy food incentives earned and/or redeemed
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start29 May 2021
- Primary completion28 Feb 2024
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Alberta Health services, Alberta Blue Cross, Nu Skin Enterprises, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dana Lee Olstad, University of Calgary
- Investigators
- Dana Olstad, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725630
- Sponsor's protocol ID
- REB20-0543
- Status last verified
- Jun 2026
- First submitted
- 19 Jan 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35168964
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Healthy Food Prescription Incentive Program for Adults With Type 2 Diabetes Who Are Experiencing Food Insecurity
- ClinicalTrials.gov ID
- NCT04725630
- Acronym / sponsor ID
- REB20-0543
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Alberta Health services, Alberta Blue Cross, Nu Skin Enterprises, Canadian Institutes of Health Research (CIHR)
- Study start
- 29 May 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subsidized Healthy Food Prescription Incentive | Experimental | Behavioral: Healthy food incentive, Behavioral: Healthy food prescriptionParticipants 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. |
| Healthy Food Prescription Comparison | Active comparator | Behavioral: Healthy food prescriptionParticipants 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy food incentive$10.50/week/household member for 12 months to purchase healthy foods in participating supermarkets. | Behavioural | Subsidized Healthy Food Prescription Incentive |
| Healthy food prescriptionA one-time healthy food prescription pamphlet | Behavioural | Healthy Food Prescription Comparison, Subsidized Healthy Food Prescription Incentive |
Primary outcome
Blood glucose levels via hemoglobin A1C
Time frame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Difference between intervention and comparison groups in blood glucose levels measured by hemoglobin A1C
20 secondary outcomes
Blood glucose levels via elevated hemoglobin A1C
Time frame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Blood glucose levels via fructosamine
Time frame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Overall diet quality by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019
Time frame: Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months)
Diet quality sub-scores by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019
Time frame: Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months)
Fruit and vegetable intake via skin carotenoids
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Blood Lipids
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Blood Pressure
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Body Mass Index
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Waist Circumference
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Anti-hyperglycemic Medication/Insulin
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
World Health Organization-5 Well-Being Scale scores
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Stanford Diabetes Self-efficacy Scale scores
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Diabetes Self-Management Questionnaire scores
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Problem Areas in Diabetes Scale scores
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
EQ-5D-5L scores
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Hypoglycemic Episodes
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Barriers to Care for People with Chronic Health Conditions scores
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Health Canada's Household Food Security Survey Module scores
Time frame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Diabetes Competing Demands scores
Time frame: Assessed at Baseline (0 months) and Follow-up (12 months)
Dose-response analyses
Time frame: 0-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Derived from this study: PubMed 35168964Olstad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Olstad, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy food incentive and Healthy food prescription in people with Diet, Healthy and Diabetes Mellitus, Type 2, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose levels via hemoglobin A1C (time frame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.