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Healthy Food Incentives for Type 2 Diabetes
N/A
Waitlist Available
Led By Dana Olstad, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline (0 months) and follow-up (6 months, 12 months, 18 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate the reach, effectiveness, adoption, implementation, and maintenance of a healthy food prescription incentive program among adults who are experiencing food insecurity and persistent hyperglycemia.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the interventions involve dietary changes rather than medications, typical drug side effects are not expected. However, participants may experience changes in their diet-related health status.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline (0 months) and follow-up (6 months, 12 months, 18 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline (0 months) and follow-up (6 months, 12 months, 18 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood glucose levels via hemoglobin A1C
Secondary study objectives
Anti-hyperglycemic Medication/Insulin
Barriers to Care for People with Chronic Health Conditions scores
Blood Lipids
+16 moreOther study objectives
MacArthur Scale of Subjective Social Status scores
Medication Adherence
Perceived Income Adequacy
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 Location
Who is running the clinical trial?
Nu Skin EnterprisesIndustry Sponsor
3 Previous Clinical Trials
178 Total Patients Enrolled
Nu SkinUNKNOWN
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,476 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your A1c level is below 6.5% or above 12%.Adults between 18 and 85 years old with type 2 diabetes or diabetes of unknown cause.You are showing signs of metabolic problems like weight loss, excessive thirst, and frequent urination.You had a serious diabetic emergency in the past year.You have been diagnosed with an eating disorder like anorexia nervosa or bulimia.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.You had a low blood sugar event in the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Subsidized Healthy Food Prescription Incentive
- Group 2: Healthy Food Prescription Comparison
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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