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Healthy Food Incentives for Type 2 Diabetes

N/A

Recruiting

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

Study 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.Check my eligibility

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.See study design

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline (0 months) and follow-up (6 months, 12 months, 18 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood glucose levels via hemoglobin A1C

Secondary outcome measures

Anti-hyperglycemic Medication/Insulin

Barriers to Care for People with Chronic Health Conditions scores

Blood Lipids

+16 more

Other outcome measures

MacArthur Scale of Subjective Social Status scores

Medication Adherence

Perceived Income Adequacy

+4 more

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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nu SkinUNKNOWN

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,343 Previous Clinical Trials

26,452,499 Total Patients Enrolled

Alberta Blue CrossUNKNOWN

Media Library

Healthy food prescription Clinical Trial Eligibility Overview. Trial Name: NCT04725630 — N/A

Type 2 Diabetes Research Study Groups: Subsidized Healthy Food Prescription Incentive, Healthy Food Prescription Comparison

Type 2 Diabetes Clinical Trial 2023: Healthy food prescription Highlights & Side Effects. Trial Name: NCT04725630 — N/A

Healthy food prescription 2023 Treatment Timeline for Medical Study. Trial Name: NCT04725630 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the necessary qualifications to join this research endeavor?

"This clinical trial is recruiting 594 diabetic individuals whose ages range from 18 to 85. Connected requirements are that the candidates must be able to communicate in English or have someone who can translate for them, possess hyperglycemia (i.e., hemoglobin A1C 6.5-12%), and encounter food insecurity as well as financial hardship when attempting to make ends meet."

Answered by AI

How many participants have been accepted into this experiment?

"Affirmative. According to the information from clinicaltrials.gov, this medical experiment is currently seeking participants and was initially published on May 29th 2021. The latest update of the study happened on September 26th 2022, with 594 patients needed for enrolment at a single site."

Answered by AI

Does this medical trial encompass the geriatric population?

"This study seeks to enrol patients aged between 18 and 85, while those younger than 18 or older than 65 may participate in 206 and 1111 trials respectively."

Answered by AI

Is it possible to volunteer for this research endeavor?

"This clinical trial, which was initially posted on May 29th 2021, is currently enlisting participants. Recent updates to the study were recorded as recently as September 26th 2022."

Answered by AI

Recent research and studies

BMJ OpenJournal

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

Olstad, Dana Lee, Reed Beall, Eldon Spackman, Sharlette Dunn, Lorraine L Lipscombe, Kienan Williams, Richard Oster, et al.. 2022. “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. BMJ. doi:10.1136/bmjopen-2021-050006.

clinicaltrials.govStudy

Healthy Food Prescription Incentive Program

Dana Olstad 2021. "Healthy Food Prescription Incentive Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725630.