Clinical trial NCT04725630: Healthy Food Prescription Incentive Program
Official title: A Healthy Food Prescription Incentive Program for Adults With Type 2 Diabetes Who Are Experiencing Food Insecurity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diet, Healthy
Diabetes Mellitus, Type 2
Diabetes Complications
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
name: Alberta Health services
name: Alberta Blue Cross
name: Nu Skin Enterprises
name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-01-27
Enrollment: 597
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Blood glucose levels via hemoglobin A1C
timeFrame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Secondary outcomes:
measure: Blood glucose levels via elevated hemoglobin A1C
timeFrame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
measure: Blood glucose levels via fructosamine
timeFrame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
measure: Overall diet quality by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019
timeFrame: Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months)
measure: Diet quality sub-scores by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019
timeFrame: Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months)
measure: Fruit and vegetable intake via skin carotenoids
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Blood Lipids
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Blood Pressure
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Body Mass Index
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Waist Circumference
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Anti-hyperglycemic Medication/Insulin
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: World Health Organization-5 Well-Being Scale scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Stanford Diabetes Self-efficacy Scale scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Diabetes Self-Management Questionnaire scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Problem Areas in Diabetes Scale scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: EQ-5D-5L scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Hypoglycemic Episodes
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Barriers to Care for People with Chronic Health Conditions scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Health Canada's Household Food Security Survey Module scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
measure: Diabetes Competing Demands scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
Other outcomes:
measure: MacArthur Scale of Subjective Social Status scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Work Productivity and Activity Impairment scores
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Perceived Income Adequacy
timeFrame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
measure: Medication Adherence
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Physical Activity Adherence
timeFrame: Assessed at Baseline (0 months) and Follow-up (12 months)
measure: Subgroup analyses
timeFrame: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
measure: Proportion of energy from ultra-processed foods
timeFrame: Assessed twice at Baseline (0 months) and twice at Follow-up (6 months, 12 months, 18 months)
Locations:
city: Multiple Locations
country: Canada
facility: Primary Care Clinics
state: Alberta
Study officials:
affiliation: University of Calgary
name: Dana Olstad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.