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.
Eligible Conditions
- Type 2 Diabetes
- Diabetes Complications
- Healthy Eating
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 23 Secondary · Reporting Duration: Assessed at Baseline (0 months) and Follow-up (6 months, 12 months, 18 months)
Month 12
Anti-hyperglycemic Medication/Insulin
Barriers to Care for People with Chronic Health Conditions scores
Blood Lipids
Blood Pressure
Body Mass Index
Diabetes Competing Demands scores
Diabetes Self-Management Questionnaire scores
EQ-5D-5L scores
Fruit and vegetable intake via skin carotenoids
Hypoglycemia
MacArthur Scale of Subjective Social Status scores
Medication Adherence
Physical Activity Adherence
Problem Areas in Diabetes Scale scores
Stanford Diabetes Self-efficacy Scale scores
Waist Circumference
Work Productivity and Activity Impairment scores
World Health Organization-5 Well-Being Scale scores
Month 18
Blood Glucose
Blood glucose levels via fructosamine
Blood glucose levels via hemoglobin A1C
Health Canada's Household Food Security Survey Module scores
Perceived Income Adequacy
Subgroup analyses
Month 6
Blood glucose levels via elevated hemoglobin A1c
Medication/Insulin
Month 18
Diet quality sub-scores by Healthy Eating Index-2015
Diet quality sub-scores by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019
Intake of ultra-processed foods
Overall diet quality by Healthy Eating Food Index - 2019
Overall diet quality by Healthy Eating Index-2015
Overall diet quality by Healthy Eating Index-2015 and by Healthy Eating Food Index-2019
Proportion of energy from ultra-processed foods
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Healthy Food Prescription Comparison
1 of 3
Subsidized Healthy Food Prescription Intervention
1 of 3
Subsidized Healthy Food Prescription Incentive
1 of 3
Active Control
Experimental Treatment
594 Total Participants · 3 Treatment Groups
Primary Treatment: Healthy food subsidy · No Placebo Group · N/A
Subsidized Healthy Food Prescription InterventionExperimental Group · 2 Interventions: Healthy food subsidy, Healthy food prescription · Intervention Types: Behavioral, Behavioral
Subsidized Healthy Food Prescription IncentiveExperimental Group · 2 Interventions: Healthy food incentive, Healthy food prescription · Intervention Types: Behavioral, Behavioral
Healthy Food Prescription Comparison
Behavioral
ActiveComparator Group · 1 Intervention: Healthy food prescription · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at baseline (0 months) and follow-up (6 months, 12 months, 18 months)
Who is running the clinical trial?
Nu SkinUNKNOWN
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,233 Previous Clinical Trials
24,676,058 Total Patients Enrolled
Alberta Blue CrossUNKNOWN
University of CalgaryLead Sponsor
706 Previous Clinical Trials
493,127 Total Patients Enrolled
Alberta Innovates Health SolutionsOTHER
49 Previous Clinical Trials
104,258 Total Patients Enrolled
Alberta Health servicesOTHER
145 Previous Clinical Trials
309,524 Total Patients Enrolled
Dana Olstad, PhDPrincipal InvestigatorUniversity of Calgary
Eligibility Criteria
Age 18 - 85 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are currently experiencing food insecurity and/or report that it is difficult/very difficult to make ends meet.
You have persistent hyperglycemia (i.e
References
- 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.
- 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.
- Dana Olstad 2021. "Healthy Food Prescription Incentive Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725630.
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Conditions
Cancer Related
Treatments