597 Participants Needed

Healthy Food Incentives for Type 2 Diabetes

DO
SD
Overseen BySharlette Dunn, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

DO

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.
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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
2Treatment groups
Experimental Treatment
Active Control
Group I: Subsidized Healthy Food Prescription IncentiveExperimental Treatment2 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 ComparisonActive Control1 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).

Find a Clinic Near You

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+
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