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
Colleen Norris,
Tyler Williamson,
Richard Oster,
Dana Lee Olstad,
Laura White,
David J T Campbell,
Sharlette Dunn,
Kim D Raine,
Mary L'Abbé,
Richard Lewanczuk,
Lorraine L Lipscombe,
Eldon Spackman,
Reed Beall,
Kienan Williams,
Sara Scott,
Gabrielle L Zimmermann,
Kerry A McBrien,
Kieran J D Steer,
Catherine B Chan,
Sheila Tyminski,
Seth Berkowitz,
Alun L Edwards,
Terry Saunders-Smith,
Saania Tariq,
Naomi Popeski,
Sara Nejatinamini,
Aruba Naser,
Carlota Basualdo-Hammond,
Petra O’Connell,
Judy Seidel,
Jason Cabaj
Affiliations
Colleen Norris
6 Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada
Tyler Williamson
Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Richard Oster
Department of Agricultural, Food & Nutritional Sciences, University of Alberta, Edmonton, Alberta, Canada
Dana Lee Olstad
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Laura White
CR UK & UCL Cancer Trials Centre, University College London, London, UK
David J T Campbell
Medicine, University of Calgary, Calgary, Alberta, Canada
Sharlette Dunn
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Kim D Raine
School of Public Health, University of Alberta, 3-300 Edmonton Clinic Health Academy, Edmonton, Alberta, Canada
Mary L'Abbé
Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
Richard Lewanczuk
Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Calgary, Alberta, Canada
Lorraine L Lipscombe
Women`s College Research Institute, Women’s College Hospital, Toronto, Ontario, Canada
Eldon Spackman
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Reed Beall
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Kienan Williams
Alberta Health Services, Calgary, Alberta, Canada
Sara Scott
Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Gabrielle L Zimmermann
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Kerry A McBrien
Department of Family Medicine, G012 Health Sciences Centre, 3330 Hospital Drive NW, Calgary, Alberta, Canada
Kieran J D Steer
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Catherine B Chan
Department of Agricultural, Food & Nutritional Sciences, University of Alberta, Edmonton, Alberta, Canada
Sheila Tyminski
Nutrition Services, Alberta Health Services, Edmonton, Alberta, Canada
Seth Berkowitz
Division of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Gatineau, Quebec, Canada
Alun L Edwards
Department of Medicine, Cumming School of Medicine, University of Calgary Foothills Medical Centre, Calgary, Alberta, Canada
Terry Saunders-Smith
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Saania Tariq
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Naomi Popeski
Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Sara Nejatinamini
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Aruba Naser
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Carlota Basualdo-Hammond
Nutrition Services, Alberta Health Services, Edmonton, Alberta, Canada
Petra O’Connell
Diabetes, Obesity and Nutrition Strategic Clinical Network, Alberta Health Services, Calgary, Alberta, Canada
Judy Seidel
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Jason Cabaj
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Introduction The high cost of many healthy foods poses a challenge to maintaining optimal blood glucose levels for adults with type 2 diabetes mellitus who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid acute care use. We will use a type 2 hybrid-effectiveness design to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of a healthy food prescription incentive programme for adults experiencing food insecurity and persistent hyperglycaemia. A randomised controlled trial (RCT) will investigate programme effectiveness via impact on glycosylated haemoglobin (primary outcome), food insecurity, diet quality and other clinical and patient-reported outcomes. A modelling study will estimate longer-term programme effectiveness in reducing diabetes-related complications, resource use and costs. An implementation study will examine all RE-AIM domains to understand determinants of effective implementation and reasons behind programme successes and failures.Methods and analysis 594 adults who are experiencing food insecurity and persistent hyperglycaemia will be randomised to a healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297). Both groups will receive a healthy food prescription. The incentive group will additionally receive a weekly incentive (CDN$10.50/household member) to purchase healthy foods in supermarkets for 6 months. Outcomes will be assessed at baseline and follow-up (6 months) in the RCT and analysed using mixed-effects regression. Longer-term outcomes will be modelled using the UK Prospective Diabetes Study outcomes simulation model-2. Implementation processes and outcomes will be continuously measured via quantitative and qualitative data.Ethics and dissemination Ethical approval was obtained from the University of Calgary and the University of Alberta. Findings will be disseminated through reports, lay summaries, policy briefs, academic publications and conference presentations.Trial registration number NCT04725630.Protocol version Version 1.1; February 2022