Healthy Food Incentives for Type 2 Diabetes

Overseen By Sharlette Dunn, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Eating disorders, Pregnancy, Metabolic decompensation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 months

597 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Dana Olstad, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for adults aged 18-85 with type 2 diabetes and persistent high blood sugar, who struggle to afford healthy food. Participants must speak English or have a translator, not plan extensive travel outside Canada, be able to shop at certain supermarkets, and not live in meal-providing facilities.

Inclusion Criteria

Can communicate in English or have someone to translate

You have long-lasting high blood sugar levels (hemoglobin A1C 6.5-12%).

Currently having trouble getting enough food to eat or finding it hard to afford basic needs.

Exclusion Criteria

Your A1c level is below 6.5% or above 12%.

Plan to leave for Canada for more than 2 weeks in the next 12 months

You are showing signs of metabolic problems like weight loss, excessive thirst, and frequent urination.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a healthy food prescription pamphlet and a weekly incentive to purchase healthy foods for 12 months

12 months

Baseline, 6 months, 12 months, 18 months

Follow-up

Participants are monitored for changes in blood glucose levels, diet quality, and other health outcomes

6 months

Follow-up assessments at 6 months, 12 months, 18 months

Treatment Details

Interventions

• Healthy food incentive
• Healthy food prescription
• Healthy food subsidy

Trial Overview The study tests if giving incentives to buy healthy foods can better control blood sugar in diabetics facing food insecurity than just prescribing healthy foods. It includes a randomized controlled trial comparing these two approaches.

Participant Groups

Group I: Subsidized Healthy Food Prescription Incentive Experimental Treatment 2 Interventions

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 II: Healthy Food Prescription Comparison Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Nu Skin Enterprises

Industry Sponsor

Trials

4

Recruited

780+

Nu Skin

Collaborator

Trials

1

Recruited

600+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Alberta Blue Cross

Collaborator

Trials

1

Recruited

600+

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+