Healthy Food Prescription Incentive Program

NCT04725630 | Completed

• 1 other identifier: REB20-0543
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Blood glucose levels via hemoglobin A1C

  Difference between intervention and comparison groups in blood glucose levels measured by hemoglobin A1C

  Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)

Secondary Outcomes (20)

• Blood glucose levels via elevated hemoglobin A1C

  Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)

• Blood glucose levels via fructosamine

  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

  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

  Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months)

• Fruit and vegetable intake via skin carotenoids

  Assessed at Baseline (0 months) and Follow-up (12 months)

Other Outcomes (7)

• MacArthur Scale of Subjective Social Status scores

  Assessed at Baseline (0 months) and Follow-up (12 months)

• Work Productivity and Activity Impairment scores

  Assessed at Baseline (0 months) and Follow-up (12 months)

• Perceived Income Adequacy

  Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)

Study Arms (2)

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.

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).

Behavioral: Healthy food prescription

Interventions

Healthy food incentive BEHAVIORAL

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

Subsidized Healthy Food Prescription Incentive

Healthy food prescription BEHAVIORAL

A one-time healthy food prescription pamphlet

Healthy Food Prescription Comparison; Subsidized Healthy Food Prescription Incentive

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Innovates Health Solutions: collaborator
• Alberta Health services: collaborator
• Alberta Blue Cross: collaborator
• Nu Skin Enterprises: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Primary Care Clinics

Various Cities, Alberta, Canada

Location

Related Publications (1)

• 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.

  PMID: 35168964 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dana Olstad, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators will be blinded to group allocation during data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: May 29, 2021
• Primary Completion: February 28, 2024
• Study Completion: March 7, 2025
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)